“GMP, GHP, GLP Practices Relevant to Minor

Forest Produce Processing. HACCP & its

implementation”

“ Aakansha Management Consultancy”

Journey to food safety
Introduction of Trainer

 SUDHIR SUDHAKAR KALSULKAR

 Food Technologist I.C.T Mumbai (Formerly UDCT)
 23 yrs. of experience including Mfg. and FOOD safety management
 Auditor ISO 9001, ISO 22000 , BRC and FSSC
 GMP plus International registered consultant –Netherlands for feed safety
 FOSTAC trainer
 WASH auditor-QCI
People have right to expect the food they eat
to be safe and suitable for consumption
Food safety
What is food safety ?
Food safety is an important issue to consumers and Food business
operators.
If food become unsafe, it may lead to food born illness, injury and in the
worst case scenario it cause death.

Definition
assurance that food will not cause an adverse health effect for the
consumer when it is prepared and/or consumed in accordance with its
intended use

Making food safe to eat free from disease causing agents (hazards)
Why do we need
Food Safety?
 Why do we need Food Safety ?

Because eating unsafe food leads to food borne illness.

Food borne illness and foodborne injury are at best unpleasant; at worst, they can be
fatal.

 Food from Unsafe

Sources
 Inadequate Cooking
 Improper Holding
Temperatures
 Contaminated
Equipment
 Poor Personal Hygiene
 Why do we need
Food Safety?

But there are also other consequences.

Outbreaks of foodborne illness can damage trade, brand image and tourism,
and lead to loss of economy/earnings, unemployment and litigation.

Food spoilage is wasteful, costly and can adversely affect trade and consumer
confidence.
 Why do we need
Food Safety?
 International food trade, and foreign travel, are increasing, bringing important social and economic
benefits.

 But this also makes the spread of illness around the world easier.

 Eating habits too, have undergone major change in many countries over the last two decades and
new food production, preparation and distribution techniques have developed to reflect this.

 Effective hygiene control, therefore, is vital to avoid the adverse human health and economic
consequences of foodborne illness, food borne injury, and food spoilage.

 Everyone, including farmers and growers, manufacturers and processors, food handlers and
consumers, has a responsibility to assure that food is safe and suitable for consumption.
Responsibility

Everyone, including primary producers, importers, manufacturers and

processors, food warehouse/logistics operators, food handlers, retailers, and
consumers, has a responsibility to ensure that food is safe and suitable for
consumption.
Food Business Operators (FBOs) should be aware of and understand the
hazards associated with the food they produce, transport, store and sell, and
the measures required to control those hazards relevant to their business, so
that food reaching consumers is safe and suitable for use.
Why food becomes unsafe?
A food becomes unsafe when it is attacked by biological, chemical and
physical hazards
example
 Spoilage
 Adulteration
 Food poisoning
 Receiving spoiled and contaminated raw material
 Cross contamination
 Food recall
 Food frauds etc.
HACCP
HAZARD ANALYSIS CRITICAL CONTROL POINTS
Hazard analysis and critical control points, or HACCP is a systematic
preventive approach to food safety from biological, chemical, physical
hazards and more recently radiological hazards in production processes that
can cause the finished product to be unsafe and designs measures to reduce
these risks to a safe level. In this manner, HACCP attempts to avoid hazards
rather than attempting to inspect finished products for the effects of those
hazards. The HACCP system can be used at all stages of a food chain,
from food production and preparation processes including packaging,
distribution, etc
Hazards
What is Hazards?
A hazard is a potential source of harm. Substances, events, or circumstances
can constitute hazards when their nature would allow them, even just
theoretically, to cause damage to health, life, property, or any other interest
of value. The probability of that harm being realized in a specific incident,
combined with the magnitude of potential harm, make up its risk, a term
often used synonymously in colloquial speech.
Codex definition
Hazard - a biological, chemical or physical agent in, or condition of, food
with the potential to cause an adverse health effect
Food safety Hazards (ISO 22000:2018)
biological, chemical or physical agent in food (3.18) with the potential to
cause an adverse health effect
Foundation

Before implementation of HACCP – HAZARD ANALYSIS

CRITICAL CONTROL POINT -Food safety system
The following are the prerequisite programs to build up the foundation for food safety
must be in place
GAP- Good agricultural practices
GMP- Good manufacturing practises
GHP-Good hygiene practices
GSP- Good storage practices
GLP- Good laboratory practices
GMP –Good manufacturing practices
Good Manufacturing Practices (GMP) is a system that ensures that the goods produced
by various manufacturing facilities are consistently produced and controlled according
to specified quality standards. There are GMP systems for everything from cosmetics to
pharmaceutical products to, of course, food.
GMP looks at every aspect of the manufacturing process to guard against potential risks
that can prove detrimental to the products being produced. Cross-contamination,
mislabeling, and adulteration are just a few of the things GMP aims to prevent.
The FDA regulates the Current Good Manufacturing Practices (CGMP), and therefore
requires companies to abide by their specified guidelines. They are considered "Current"
because, as new information is discovered, the Good Manufacturing Practices released
by the government will change to reflect the new finding(s).
These Practices are made to be flexible, to better allow companies to adjust them to fit
their specific needs. However, to meet the GMP and CGMP guidelines, certain areas still
have to be met accordingly.
GMP –Good manufacturing practices
WHY GMP IS IMP?
 GMP help ensure the proper design, monitoring, and control of the
manufacturing processes and facilities.
 Companies that adhere to these standards help to assure the identity,
strength, and quality of their products.
 When implemented, GMP can help to cut down on facility losses and
waste and also help to protect the company, consumer, and the
environment from harm.
WHAT GOES INTO GOOD MANUFACTURING PRACTICES
IN FOOD INDUSTRY MANUFACTURERS?

1. Sanitation and hygiene

2. Suitable facility and locations
3. Equipment's
4. Raw material and storage
5. Personal
6. Validation and qualification
7. Complaint handling
8. Documentation and record keeping
9. Inspection and quality audits
Good hygiene practices
Good Hygiene Practices (GHPs):
Fundamental measures and conditions applied at any step within the food chain to
provide safe and suitable food.

Good Hygiene Practices are the set of requirements to prevent contamination of food
in order to provide safe food to the consumers. Food borne illnesses can result from
contamination due to improper practices like when there is lack of environmental
hygiene and poor sanitation. mixed and inappropriate transportation.
WHAT GOES INTO GOOD MANUFACTURING
PRACTICES IN FOOD INDUSTRY MANUFACTURERS?

 Primary production
 Environmental hygiene
 Hygiene production of food sources
 Handling , storage and transport
 Cleaning , maintenance and personal hygiene
 Establishment Design and Facilities
 Control of operations
 Maintenance and sanitation
 Personal Hygiene
 Transportation
 Product information and consumer awareness
 Training
Good manufacturing practise and Good
hygiene practise

 In order to avoid adverse human health and economic consequences it is

absolutely follow good manufacturing practises (GMP) and good hygiene
practices(GHP)
 GMP and GHPs are the general principles that lay a firm foundations to
ensuring safe food.
 It is a responsibility of FBO to make sure that GMP and GHP are followed
correctly.
Codex Alimentarius Commission (CAC)
Codex Alimentarius The Codex Alimentarius Commission develops and adopts food
standards that serve as a reference for international food trade.
To implement HACCP in the food processing plant GMP and GHP are the general
principals that lay a firm foundation to ensure food safety.
Codex Alimentarius commission has given this course of practices or prps to protect the
health of customer and to ensure fare trade practices.
GENERAL PRINCIPLES OF FOOD HYGIENE
 CXC 1-1969
 Adopted in 1969. Amended in 1999. Revised in 1997, 2003, 2020. Editorial corrections
in 2011.
Covers GMP and GHP.
PREREQUISITE PROGRAMME(GMP & GHP)
PREREQUISITE PROGRAMME(GMP & GHP)
Section 2 :PRIMARY PRODUCTION
Primary production should be managed in a way that ensures that food is safe and
suitable for its intended use. Where necessary, this will include:
 avoiding the use of areas where the environment poses a threat to the safety of
food;
 controlling contaminants, pests and diseases of animals and plants in such a way as
not to pose a threat to food safety,
 adopting practices and measures to ensure food is produced under appropriately
hygienic conditions.
2.1 ENVIRONMENTAL HYGIENE
Potential sources of contamination from the environment should be considered.
In particular, primary food production should not be carried on in areas where the
presence of potentially harmful substances would lead to an unacceptable level of
such substances in food.
PREREQUISITE PROGRAMME(GMP & GHP)
2.2 HYGIENIC PRODUCTION OF FOOD SOURCES
The potential effects of primary production activities on the safety and suitability of food
should be considered at all times. In particular, this includes identifying any specific
points in such activities where a high probability of contamination may exist and taking
specific measures to minimize and, if possible, eliminate that probability.
Producers should as far as practicable implement measures to:
 control contamination from soil, water, feedstuffs, fertilizers (including natural
fertilizers), pesticides, veterinary drugs or any other agent used in primary production;
 protect food sources from fecal and other contamination (e.g. zoonotic foodborne
agents);
 control plant and animal health so that it does not pose a threat to human health
through food consumption, or adversely affect the suitability of the product (e.g.
observe the withdrawal period of veterinary drugs and pesticides, keeping records
where applicable); and
 manage waste and store harmful substances appropriately.
PREREQUISITE PROGRAMME(GMP & GHP)
2.3 Handling, Storage and Transport
Procedures should be in place to:
 sort food to remove material which should not be used for human consumption;
 dispose of any rejected material in a hygienic manner; and
 protect food from contamination by pests, or by chemical, physical or microbiological contaminants
or other objectionable substances during handling (e.g. sorting, grading, washing), storage and
transport. Care should be taken to prevent deterioration and spoilage through appropriate measures
which may include controlling temperature, humidity, and/or other controls.
2.4 Cleaning, Maintenance and Personnel Hygiene
Appropriate facilities and procedures should be in place to ensure that:
 cleaning and maintenance are carried out effectively and do not compromise food safety (e.g.
ensuring equipment used in harvest is not a source of contamination); and
 an appropriate degree of personal hygiene is maintained to ensure personnel are not a source of
contamination (e.g. by human faces).
PREREQUISITE PROGRAMME(GMP & GHP)
SECTION 3: ESTABLISHMENT - DESIGN OF FACILITIES AND EQUIPMENT
Depending on the nature of the operations, and the risks associated with them,
premises, equipment and facilities should be located, designed and constructed to
ensure that:
 contamination is minimized;
 design and layout permit appropriate maintenance, cleaning and disinfection and
minimize airborne contamination;
 surfaces and materials, in particular those in contact with food, are non-toxic for their
intended use;
 where appropriate, suitable facilities are available for temperature, humidity and
other controls;
 there is effective protection against pest access and harbourage; and
 there are sufficient and appropriate washroom facilities for personnel.
Attention to good hygienic design and construction, appropriate location, and the
provision of adequate facilities is necessary to enable contaminants to be effectively
controlled.
PREREQUISITE PROGRAMME(GMP & GHP)
3.1 Location and structure
3.1.1 Establishment
Establishments should not be located anywhere where, after considering such
protective measures, it is clear that there will remain a threat to food safety or suitability.
In particular, establishments should normally be located away from:
 environmentally polluted areas and industrial activities which pose a serious threat of
contaminating food;
 areas subject to flooding unless sufficient safeguards are provided;
 areas prone to infestations of pests;
 areas where wastes, either solid or liquid, cannot be removed effectively.
PREREQUISITE PROGRAMME(GMP & GHP)

3.1.2 Design and layout of food establishment

Should permit adequate maintenance and cleaning
cross-contamination is minimized or prevented.
Areas having different levels of hygiene control (e.g. the raw material and finished
product areas) should be separated to minimize cross-contamination through measures
such as physical separation (e.g. walls, partitions) and/or location (e.g. distance), traffic
flow (e.g. one-directional production flow), airflow, or separation in time, with suitable
cleaning and disinfection between uses.
PREREQUISITE PROGRAMME(GMP & GHP)
3.1.3 Internal structures and fittings
Should be soundly built of durable materials, which are easy to maintain, clean and, where appropriate, easy to
disinfect. They should be constructed of non-toxic and inert materials according to intended use and normal
operating conditions.
following specific conditions should be satisfied where necessary to protect the safety and suitability of food:
 the surfaces of walls, partitions and floors should be made of impervious materials that are easy to clean and,
where necessary, disinfect;
 walls and partitions should have a smooth surface up to a height appropriate to the operation;
 floors should be constructed to allow adequate drainage and cleaning;
 ceilings and overhead fixtures (e.g. lighting) should be constructed to be shatterproof where appropriate, and
finished to minimize the build-up of dirt and condensation and the shedding of particles;
 windows should be easy to clean, be constructed to minimize the build-up of dirt and, where necessary, be fitted
with removable and cleanable insect-proof screens; and
 doors should have smooth, non-absorbent surfaces, be easy to clean and, where necessary, disinfect.
 Work surfaces that come into direct contact with food should be in sound condition, durable, and easy to clean,
maintain and disinfect. They should be made of smooth, non-absorbent materials, and inert to the food, to
detergents and to disinfectants under normal operating conditions.
PREREQUISITE PROGRAMME(GMP & GHP)

3.1.4 Temporary/mobile food establishments and vending machines

 Establishments and structures covered here include market stalls, street vending
vehicles, vending machines and temporary premises such as tents and marquees.
 Such premises and structures should be located, designed and constructed to avoid,
as far as reasonably practicable, the contamination of food and the harbouring of
pests. Adequate facilities for toileting and washing hands should be provided, where
appropriate.
PREREQUISITE PROGRAMME(GMP & GHP)
3.2 Facilities
 3.2.1 Drainage and waste disposal facilities
 Adequate drainage and waste disposal systems and facilities should be provided
and well maintained. They should be designed and constructed so that the
likelihood of contaminating food or the water supply is avoided. For plumbing, steps
should be taken to prevent backflow, cross-connections, and backup of sewer
gases. It is important that drainage does not flow from highly contaminated areas
(such as toilets or raw production areas) to areas where finished food is exposed to
the environment.
 Waste should be collected, disposed of by trained personnel and, where
appropriate, disposal records maintained. The waste disposal site should be located
away from the food establishment to prevent pest infestation. Containers for waste,
by-products and inedible or hazardous substances should be specifically identifiable,
suitably constructed and, where appropriate, made of impervious material.
 Containers used to hold hazardous substances prior to disposal should be identified
and, where appropriate, be lockable to prevent intentional or accidental
contamination of food.
PREREQUISITE PROGRAMME(GMP & GHP)

3.2.2 Cleaning facilities

Adequate, suitably designated facilities should be provided for cleaning utensils and
equipment. Such facilities should have an adequate supply of hot and/or cold water,
where required. A separate cleaning area should be provided for tools and equipment
from highly contaminated areas like toilets, drainage and waste disposal areas. Where
appropriate, facilities for washing food should be separate from facilities for cleaning
utensils and equipment, and separate sinks should be available for hand washing and
food washing.
PREREQUISITE PROGRAMME(GMP & GHP)
3.2.3 Personnel hygiene facilities and toilets
Adequate washing and toilet facilities should be available so that an appropriate
degree of personal hygiene can be maintained and to avoid personnel contaminating
food. Such facilities should be suitably located and should not be used for other
purposes such as storage of food or items that contact food.
They should include:
 adequate means of washing and drying hands, including soap (preferably liquid
soap), wash basins and, where appropriate, a supply of hot and cold (or suitably
temperature controlled) water;
 hand washing basins of an appropriate hygienic design, ideally with taps not
operated by hands; where this is not possible, appropriate measures to minimize
contamination from the taps should be in place; and
 suitable changing facilities for personnel, if needed.
 Handwashing basins should not be used for washing food or utensils.
PREREQUISITE PROGRAMME(GMP & GHP)

3.2.4 Temperature
Depending on the nature of the food operations undertaken, adequate facilities
should be available for heating, cooling, cooking, refrigerating and freezing food,
for storing refrigerated or frozen foods, and, when necessary, controlling ambient
temperatures to ensure the safety and suitability of food.

.
PREREQUISITE PROGRAMME(GMP & GHP)
3.2.5 Air quality and ventilation
Adequate means of natural or mechanical ventilation should be provided, in particular
to:
 minimize air-borne contamination of food, for example, from aerosols and
condensation droplets;
 help control ambient temperatures;
 control odours which might affect the suitability of food; and
 control humidity to ensure the safety and suitability of food (e.g. to prevent an
increase in moisture of dried foods that would allow growth of microorganisms and
production of toxic metabolites).
 Ventilation systems should be designed and constructed so that air does not flow
from contaminated areas to clean areas; the systems should be easy to maintain
and clean.
PREREQUISITE PROGRAMME(GMP & GHP)

3.2.6 Lighting
Adequate natural or artificial lighting should be provided to enable the food business to
operate in a hygienic manner. Lighting should be such that it does not adversely impact
the ability to detect defects of, or contaminants in, food or the examination of facilities
and equipment for cleanliness. The intensity should be adequate to the nature of the
operation. Light fittings should, where appropriate, be protected to ensure that food is
not contaminated by breakages of lighting elements
PREREQUISITE PROGRAMME(GMP & GHP)
3.2.7 Storage
Adequate and, where necessary, separate facilities for the safe and hygienic storage of
food products, food ingredients, food packaging materials and non-food chemicals
(including cleaning materials, lubricants, fuels), should be provided. Storage should allow
for segregation of raw and cooked foods or allergenic and non-allergenic food.
Food storage facilities should be designed and constructed to:
 facilitate adequate maintenance and cleaning;
 avoid pest access and harborage;
 enable food to be effectively protected from contamination, including allergen
cross-contact, during storage; and
 where necessary, provide an environment which minimizes the deterioration of food
(such as by temperature and humidity control).
 The type of storage facilities required will depend on the nature of the food.
Separate, secure, storage facilities for cleaning materials and hazardous substances
should be provided.
PREREQUISITE PROGRAMME(GMP & GHP)

3.3 Equipment
Equipment and containers coming into contact with food should be suitable for food
contact; designed, constructed and located to ensure that they can be adequately
cleaned (other than containers which are single-use only); disinfected (where
necessary); and maintained or discarded as necessary to avoid the contamination of
food, according to hygienic design principles. Equipment and containers should be
made of materials that are non-toxic according to intended use. Where necessary,
equipment should be durable and movable or capable of being disassembled to
allow for maintenance, cleaning, disinfection and to facilitate inspection for pests.
PREREQUISITE PROGRAMME(GMP & GHP)
3.3.2 Food control and monitoring equipment
Equipment used to cook, heat, cool, store or freeze food should be designed to achieve
the required food temperatures as rapidly as necessary in the interests of food safety
and suitability, and to maintain food temperatures effectively.
Such equipment should also be designed to allow temperatures to be monitored, where
necessary, and controlled. Where appropriate, monitoring equipment should be
calibrated to ensure that temperatures of food processes are accurate.
Where necessary, such equipment should have effective means of controlling and
monitoring humidity, air-flow and any other characteristics likely to have an effect on the
safety or suitability of food.
PREREQUISITE PROGRAMME(GMP & GHP)

SECTION 4: TRAINING AND COMPETENCE

All those engaged in food operations who come directly or indirectly into contact with
food should have sufficient understanding of food hygiene to ensure they have
competence appropriate to the operations they are to perform.
Training is fundamentally important to any food hygiene system and the competence of
personnel.
Adequate hygiene training, and/or instruction and supervision of all personnel involved
in food-related activities contribute to ensuring the safety of food and its suitability for
consumption.
 Awareness and Responsibilities
 Training Programmes
 Instruction and Supervision
 Refresher Training
PREREQUISITE PROGRAMME(GMP & GHP)

SECTION 5: ESTABLISHMENT MAINTENANCE, CLEANING AND DISINFECTION, AND PEST

CONTROL
To establish effective systems that:
• ensure appropriate establishment maintenance;
• ensure cleanliness and, when necessary, adequate disinfection;
• ensure pest control;
• ensure waste management; and
• monitor effectiveness of cleaning and disinfection, pest control and waste
management procedures.
PREREQUISITE PROGRAMME(GMP & GHP)
5.2 Pest control systems
Pests (e.g. birds, rodents, insects etc.) pose a major threat to the safety and suitability of
food. Pest infestations can occur where there are breeding sites and a supply of food.
GHPs should be employed to avoid creating an environment conducive to pests. Good
building design, layout, maintenance, and location, along with cleaning, inspection of
incoming materials and effective monitoring, can minimize the likelihood of infestation
and thereby limit the need for pesticides.
5.2.2 Prevention
5.2.3 Harbourage and infestation
5.2.4 Monitoring and detection
5.2.5 Control of pest infestation .
PREREQUISITE PROGRAMME(GMP & GHP)

5.3 Waste management

 Suitable provision should be made for the removal and storage of waste. Waste
should, as far as possible, be collected and stored in covered containers and should
not be allowed to accumulate and overflow in food handling, food storage, and
other working areas or the adjoining environment in a manner that compromises
food safety and suitability. Personnel responsible for waste removal (including
hazardous waste) should be properly trained so they do not become a source of
cross-contamination.
 Waste storage areas should be easily identifiable, be kept appropriately clean, and
be resistant to pest infestation. They should also be located away from processing
areas.
PREREQUISITE PROGRAMME(GMP & GHP)
SECTION 6: PERSONAL HYGIENE
To ensure that those who come directly or indirectly into contact with food:
• maintain appropriate personal health;
• maintain an appropriate degree of personal cleanliness; and
• behave and operate in an appropriate manner.
Personnel who do not maintain an appropriate degree of personal cleanliness, who
have certain illnesses or conditions or who behave inappropriately, can contaminate
food and transmit illness to consumers through food.
Food businesses should establish policies and procedures for personal hygiene. FBOs
should ensure all personnel are aware of the importance of good personal hygiene and
understand and comply with practices that ensure food safety and suitability.
PREREQUISITE PROGRAMME(GMP & GHP)
6.1 Health Status
 Personnel known or suspected to be ill or carrying a disease likely to be transmitted through food
should not enter any food handling area if there is a likelihood of their contaminating food. Any
person so affected should immediately report illness or symptoms of illness to the management.
 It may be appropriate for personnel to be excluded for a specific time after symptoms resolve or,
for some illnesses, to get medical clearance before returning to work.
6.2 Illness and Injuries
Some symptoms of illnesses that should be reported to management so that the need for possible
exclusion from food handling and/or medical examination can be considered include:
 jaundice; diarrhoea;

 vomiting; Fever

 sore throat with fever; visibly infected skin lesions (boils, cuts, etc.); and

 discharges from the ear, eye or nose.

Personnel with cuts and wounds should, where necessary, be assigned to work in areas where they
will have no direct contact with food. Where personnel are permitted to continue working, cuts and
wounds should be covered by suitable waterproof plasters and, where appropriate, gloves.
Appropriate measures should be applied to ensure plasters do not become a source of
contamination (e.g. plasters of contrasting colour compared to the food and/or detectable using a
metal detector or x-ray detector).
PREREQUISITE PROGRAMME(GMP & GHP)
6.3 Personal Cleanliness
 Personnel should maintain a high degree of personal cleanliness and, where
appropriate, wear suitable protective clothing, head and beard covering, and
footwear. Measures should be implemented to prevent cross-contamination by
personnel through adequate hand washing and, where necessary, the wearing of
gloves. If gloves are worn, appropriate measures should be applied to ensure the
gloves do not become a source of contamination.
 Personnel, including those wearing gloves, should clean their hands regularly,
especially when personal cleanliness may affect food safety. In particular they
should wash hands:
 at the start of food handling activities;
 when returning to work after breaks;
 immediately after using the toilet; and

 after handling any contaminated material, such as waste or raw and unprocessed
foods where this could result in contamination of other food items.
 In order not to contaminate food, personnel should wash hands with soap and water
and rinse and dry them in a manner that does not recontaminate the hands. Hand
sanitizers should not replace hand washing and should be used only after hands
have been washed.
PREREQUISITE PROGRAMME(GMP & GHP)
6.4 Personal Behaviour
When engaged in food handling activities personnel should refrain from behaviour
which could result in contamination of food, for example:
 smoking or vaping;
 spitting;
 chewing, eating, or drinking;
 touching the mouth, nose or other places of possible contamination; and
 sneezing or coughing over unprotected food.
Personal effects such as jewellery, watches, pins or other items such as false nails/eye
lashes should not be worn or brought into food handling areas if they pose a threat to
the safety and suitability of food.
PREREQUISITE PROGRAMME(GMP & GHP)
6.5 Visitors and other persons from outside the establishment
Visitors to food businesses, including maintenance workers, in particular to
food manufacturing, processing or handling areas, should, where appropriate,
be instructed and supervised, wear protective clothing and adhere to the
other personal hygiene provisions for personnel. Visitors should be guided
through a hygiene policy of the business prior to visits and encouraged to
report any type of illness/injury that may pose cross-contamination issues
PREREQUISITE PROGRAMME(GMP & GHP)
SECTION 7: CONTROL OF OPERATION
To produce food that is safe and suitable for human consumption by: formulating design
requirements with respect to raw materials and other ingredients,
composition/formulation, production, processing, distribution, and consumer use to be
met as appropriate to the food business;
designing, implementing, monitoring and reviewing effective control systems as
appropriate to the food business.

If operations are not controlled appropriately, food may become unsafe or unsuitable
for consumption.
PREREQUISITE PROGRAMME(GMP & GHP)

7.1 Description of products and processes

 Product description
 Process description
 Consideration of the effectiveness of GHPs
 Monitoring and corrective action
 Verification
PREREQUISITE PROGRAMME(GMP & GHP)
7.2 Key aspects of GHPs
 7.2.1 Time and temperature control
 7.2.2 Specific process steps
 7.2.3 Microbiological, physical, chemical and allergen specifications
 7.2.4 Microbiological contamination
 7.2.5 Physical contamination
 7.2.6 Chemical contamination
 7.2.7 Allergen Management
 7.2.8 Incoming Materials
 7.2.9 Packaging
PREREQUISITE PROGRAMME(GMP & GHP)

7.3 Water
7.4 Documentation and Records
7.5 Recall Procedures - removal from the market of unsafe food
PREREQUISITE PROGRAMME(GMP & GHP)
SECTION 8: PRODUCT INFORMATION AND CONSUMER AWARENESS
Appropriate information about food should ensure that:
 adequate and accessible information is available to the next FBO in the food chain
or the consumer to enable them to handle, store, process, prepare and display the
product safely and correctly;
 consumers can identify allergens present in foods; and
 the lot or batch can be easily identified and removed/returned if necessary.

Consumers should be given enough information on food hygiene to enable them to:
 be aware of the importance of reading and understanding the label;
 make informed choices appropriate to the individual, including about allergens; and
 prevent contamination and growth or survival of foodborne pathogens by storing,
preparing and using food correctly.
PREREQUISITE PROGRAMME(GMP & GHP)
8.1 Lot Identification and Traceability

 Lot identification or other identification strategies are essential in product recall and also help effective stock
rotation. Each container of food should be permanently marked to identify the producer and the lot. The
General Standard for the Labelling of Prepackaged Foods (CXS 1-1985) applies.

 A traceability/product tracing system should be designed and implemented according to the Principles for
Traceability/Product Tracing as a Tool within a Food Inspection and Certification System (CXG 60-2006), especially
to enable the recall of the products, where necessary.

8.2 Product Information

 All food products should be accompanied by or bear adequate information to enable the next FBO in the food
chain or the consumer to handle, prepare, display, store, and/or use the product safely and correctly.

8.3 Product Labelling

 Prepackaged foods should be labelled with clear instructions to enable the next person in the food chain to
handle, display, store and use the product safely. This should also include information that identifies food
allergens in the product as ingredients or where cross-contact cannot be excluded. The General Standard for the
Labelling of Prepackaged Foods (CXS 1-1985) applies.

8.4 Consumer Education

 Consumer education program should cover general food hygiene. Such programs should enable consumers to
understand the importance of any product label information and following any instructions accompanying
products, and to make informed choices. In particular, consumers should be informed of the relationship
between time/temperature control, cross contamination and foodborne illness, and of the presence of allergens.
Consumers should also be informed of the WHO 5 Keys to Safer Food and educated to apply appropriate food
hygiene measures (e.g. proper hand washing, adequate storage and cooking and avoiding cross
contamination) to ensure that their food is safe and suitable for consumption.
PREREQUISITE PROGRAMME(GMP & GHP)
SECTION 9: TRANSPORTATION
Food may become contaminated or may not reach its destination in a suitable
condition for consumption, unless effective hygiene practices are taken prior to and
during transport, even where adequate hygiene practices have been taken earlier in
the food chain.
During transportation, measures should be taken where necessary to:
 protect food from potential sources of contamination, including allergen cross-
contact;
 protect food from damage likely to render the food unsuitable for consumption; and
 provide an environment which effectively controls the growth of pathogenic or
spoilage micro-organisms and the production of toxins in food.
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT

The HACCP system, which is science-based and systematic, identifies specific hazards
and measures for their control to ensure the safety of food.

HACCP is a tool to assess hazards and establish control systems that focus on control
measures for significant hazards along the food chain, rather than relying mainly on end-
product testing.

Development of a HACCP system may identify the need for changes in processing
parameters, in processing steps, in manufacturing technology, in end product
characteristics, in method of distribution, in the intended use or in the GHPs applied. Any
HACCP system should be capable of accommodating change, such as advances in
equipment design, processing procedures or technological developments.
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT

HACCP principles can be considered throughout the food chain from primary
production to final consumption ( FARM- FORK), and their implementation should be
guided by scientific evidence of risks to human health.

As well as enhancing food safety, implementation of HACCP can provide other

significant benefits, such as more efficient processes based on a thorough analysis of
capability, more effective use of resources by focusing on critical areas, and fewer
recalls through identification of problems before product is released.

In addition, the application of HACCP systems can aid review by competent authorities
and promote international trade by increasing confidence in food safety.
Biological hazards
 Biological hazards can cause illness and include:
 Bacteria: E.coli, Salmonella, Listeria, Campylobacter, Shigella
 Viruses: cold viruses, Hepatitis A, Norwalk virus
 Parasites: Giardia, Cryptosporidium, Trichinella, tapeworms
 Yeasts and moulds
 Any toxin produced by microbiological organisms is also a
biological hazard
Chemical hazards

Chemical hazards can cause injury or poisoning and

include:
 Naturally occurring substances (e.g.
allergens, plant specific toxins)
 Excessive, intentionally added chemicals:
antibiotics, pesticides, herbicides, fungicides,
nitrates
 Accidentally added chemicals: cleaning
chemicals, paint, pest control chemicals
Physical hazards

 Physical hazards are foreign

objects that can cause injury:
 Glass
 Metal grindings, screws,
nuts, bolts
 Stones, pebbles
 Needles
 Hard plastic
 Bones
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT
PRINCIPLES OF THE HACCP SYSTEM
The HACCP system is designed, validated and implemented in accordance with the
following seven principles:
PRINCIPLE 1
Conduct a hazard analysis and identify control measures.
PRINCIPLE 2
Determine the Critical Control Points (CCPs).
PRINCIPLE 3
Establish validated critical limits.
PRINCIPLE 4
Establish a system to monitor control of CCPs.
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT

PRINCIPLE 5
Establish the corrective actions to be taken when monitoring indicates a deviation from
a critical limit at a CCP has occurred.
PRINCIPLE 6
Validate the HACCP plan and then establish procedures for verification to confirm that
the HACCP system is working as intended.
PRINCIPLE 7
Establish documentation concerning all procedures and records appropriate to these
principles and their application.
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT

Application of HACCP
Prior to apply HACCP principles , FBO ensures that all prerequisite programs
such GMP, GHP ,GSP and GLP should be in place.
Legal requirements should meet
Five Pre steps
 Assemble HACCP Team and Identify Scope (Step 1)
 Describe product (Step 2)
 Identify intended use and users (Step 3)
 Construct flow diagram (Step 4)
 On-site confirmation of flow diagram (Step 5)
HACCP- HAZARD ANALYSIS CRITICAL
CONTROL POINT

 List all potential hazards that are likely to occur and associated with each
step, conduct a hazard analysis to identify the significant hazards, and
consider any measures to control identified hazards (Step 6/ Principle 1)
 Determine the Critical Control Points (Step 7/ Principle 2)
 Establish validated critical limits for each CCP (Step 8/ Principle 3)
 Establish a Monitoring System for Each CCP (Step 9/ Principle 4)
 Establish corrective actions (Step 10/ Principle 5)
 Validation of the HACCP Plan and Verification Procedures (Step 11/ Principle
6)
 Establish Documentation and Record Keeping (Step 12/ Principle 7)
Good Laboratory Practices

Good laboratory practice or good laboratory practices are accepted methods to carry
out activities or operations in a laboratory. The authorities and laboratory organizations
say that these practices help ensure safety. They also have a positive influence on the
quality of the result. For pharmaceutical companies, for example, GLP compliance is
extremely important.
According to the European Commission:
“The principles of Good Laboratory Practice (GLP) promote the quality and validity of
data generated in the testing of chemicals and prevent fraudulent practices.”
GLP is the part of quality assurance that ensures the organisations consistently produce
and control produce to high quality standards
Good Laboratory Practices
 Thank you!
“Aakansha Management Consultancy”
www.amcfoodsafety.com
 GENERAL PRINCIPLES OF FOOD HYGIENE
CXC 1-1969

Adopted in 1969. Amended in 1999. Revised in 1997, 2003, 2020. Editorial corrections in 2011.
CXC 1-1969 2

INTRODUCTION
People have the right to expect the food that they eat to be safe and suitable for consumption. Foodborne
illness and foodborne injury can be severe or fatal or have a negative impact on human health over the longer
term. Furthermore, outbreaks of foodborne illness can damage trade and tourism. Food spoilage is wasteful,
costly, threatens food security and can adversely affect trade and consumer confidence.
International food trade and the flow of travellers are increasing, bringing important social and economic
benefits. However, this also makes the spread of illness around the world easier. Eating habits have undergone
major changes in many countries and new food production, preparation, storage, and distribution techniques
have developed to reflect this. Effective food hygiene practices, therefore, are vital to avoid the adverse human
health and economic consequences of foodborne illness, foodborne injury, and food spoilage. Everyone,
including primary producers, importers, manufacturers and processors, food warehouse/logistics operators,
food handlers, retailers, and consumers, has a responsibility to ensure that food is safe and suitable for
consumption. Food Business Operators (FBOs) should be aware of and understand the hazards associated
with the food they produce, transport, store and sell, and the measures required to control those hazards
relevant to their business, so that food reaching consumers is safe and suitable for use.
This document outlines the general principles that should be understood and followed by FBOs at all stages
of the food chain and that provide a basis for competent authorities to oversee food safety and suitability.
Taking into account the stage in the food chain, the nature of the product, the relevant contaminants, and
whether the relevant contaminants adversely affect safety, suitability or both, these principles will enable food
businesses to develop their own food hygiene practices and necessary food safety control measures, while
complying with requirements set by competent authorities. While it is the FBOs’ responsibility to provide safe
food, for some FBOs this may be as simple as ensuring that the WHO 5 keys to Safer Food are adequately
implemented. The 5 keys are: ‘keep clean, separate raw and cooked, cook thoroughly, keep food at safe
temperatures and use safe water and raw materials.
FBOs need to be aware of hazards that may affect their food. FBOs need to understand the consequences of
these hazards for consumer health and should ensure that they are properly managed. Good Hygiene
Practices (GHPs) are the foundation of any effective control of hazards associated with their businesses. For
some FBOs effective implementation of GHPs will be sufficient to address food safety.
The sufficiency of the implemented GHP to address food safety could be determined through conducting a
hazard analysis and determining how to control identified hazards. However, not all FBOs have the expertise
to do this. If the FBO is not able to conduct a hazard analysis, the FBO may rely on information on appropriate
food safety practices from external sources such as that provided by competent authorities, academia or other
competent bodies (e.g. trade associations or professional societies) that has been based on the identification
of relevant hazards and controls. For example, requirements in regulations for production of safe food are
based on hazard analysis often conducted by competent authorities. Similarly, guidance documents from trade
associations and other organizations that describe food safety procedures are based on hazard analyses
conducted by experts knowledgeable about the hazards and controls needed to ensure the safety of specific
types of products. When external generic guidance is used the FBO should make sure that the guidance
corresponds with the activities of the establishment and ensure all relevant hazards are controlled.
All GHPs are important but some GHPs have a greater impact on food safety. Thus, for some GHPs, based
on safety concerns with the food, greater attention may be needed to provide safe food. For example, the
cleaning of equipment and surfaces which come into contact with ready-to-eat food should warrant greater
attention than other areas such as the cleaning of walls and ceilings, because if food contact surfaces are not
properly cleaned, this could lead to direct contamination of food. Greater attention may include a higher
frequency of application, of monitoring and of verification.
In some circumstances, the implementation of GHPs may not be sufficient to ensure food safety due to the
complexity of the food operation and/or specific hazards associated with the product or process, technological
advances (e.g. extending shelf-life through modified atmosphere packaging) or end use of the product (e.g.
products destined for a special dietary purpose). In such cases, when there are significant hazards identified
through hazard analysis as not being controlled by GHPs, they should be addressed in the HACCP plan.
Chapter One of this document describes GHPs, which are the basis of all food hygiene systems to support the
production of safe and suitable food. Chapter Two describes HACCP. HACCP principles can be applied
throughout the food chain from primary production to final consumption and their implementation should be
guided by scientific evidence of risks to human health. The table in Annex 1 provides a comparison of control
measures applied as GHPs and those applied at Critical Control Points (CCPs) with examples.
CXC 1-1969 3

OBJECTIVES
The General Principles of Food Hygiene: Good Hygiene Practices (GHPs) and the Hazard Analysis and Critical
Control Point (HACCP) System aim to:
 provide principles and guidance on the application of GHPs applicable throughout the food chain to
provide food that is safe and suitable for consumption;
 provide guidance on the application of HACCP principles;
 clarify the relationship between GHPs and HACCP; and
 provide the basis on which sector and product-specific codes of practice can be established.
SCOPE
This document provides a framework of general principles for producing safe and suitable food for consumption
by outlining necessary hygiene and food safety controls to be implemented in production (including primary
production), processing, manufacturing, preparation, packaging, storage, distribution, retail, food service
operation and transport of food, and where appropriate, specific food safety control measures at certain steps
throughout the food chain.
USE
General
The document is intended for use by FBOs (including primary producers, importers, manufacturers/processors,
food warehouse/logistics operators, food service operators, retailers and traders) and competent authorities,
as appropriate. It provides basic information to meet the needs of food businesses, irrespective of the nature
of product and size of food business, in the context of food trade. However, it should be noted that it is not
possible for the document to provide specific guidance for all situations and specific types of food businesses
and the nature and extent of food safety risks associated with individual circumstances.
There will be situations where some of the specific recommendations contained in this document are not
applicable. The fundamental question for each food business operator in every case is “what is necessary and
appropriate to ensure the safety and suitability of food for consumption?”
The text indicates where such questions are likely to arise by using the phrases “where necessary” and “where
appropriate”. In deciding whether a measure is necessary or appropriate, an evaluation of the likelihood and
severity of the hazard toward establishing the potential harmful effects to consumers should be made, taking
into account any relevant knowledge of the operation and hazards, including available scientific information.
This approach allows the measures in this document to be flexibly and sensibly applied with a regard for the
overall objectives of producing food which is safe and suitable for consumption. In so doing it takes into account
the wide diversity of food chain operations and practices and varying degrees of risk to public health involved
in producing and handling food.
Roles of Competent Authorities, Food Business Operators, and Consumers
Competent authorities are responsible for deciding how these general principles are best applied through
legislation, regulation or guidance to:
 protect consumers from illness, injury, or death caused by consumption of food;
 ensure FBOs implement an effective control system so that food is safe and suitable for consumption;
 maintain confidence in domestically and internationally traded food; and
 provide information that effectively communicates the principles of food hygiene to food business
operators and consumers.
FBOs should apply the hygienic practices and food safety principles set out in this document to:
 develop, implement and verify processes that provide food that is safe and suitable for its intended
use;
 ensure personnel are competent as appropriate to their job activities;
 build a positive food safety culture by demonstrating their commitment to providing safe and suitable
food and encouraging appropriate food safety practices;
 contribute to maintaining confidence in domestically and internationally traded food; and
 ensure that consumers have clear and easily understood information to enable them to identify the
presence of food allergens, protect their food from contamination, and prevent the growth/survival of
foodborne pathogens by storing, handling and preparing food correctly.
CXC 1-1969 4

Consumers should play their role by following relevant guidance and instructions for food handling, preparation,
and storage and applying appropriate food hygiene measures.
GENERAL PRINCIPLES
(i) Food safety and suitability should be controlled using a science-based preventive approach, for
example a food hygiene system. GHPs should ensure that food is produced and handled in an
environment that minimizes the presence of contaminants.
(ii) Properly applied prerequisite programmes, which include GHPs, should provide the foundation for an
effective HACCP system.
(iii) Each FBO should be aware of the hazards associated with the raw materials and other ingredients,
the production or preparation process, and the environment in which the food is produced and/or
handled, as appropriate to the food business.
(iv) Depending on the nature of the food, food process, and the potential for adverse health effects, to
control hazards it may be sufficient to apply GHPs, including, as appropriate, some that require more
attention than others, as they have a greater impact on food safety. When the application of GHPs
alone is not sufficient, a combination of GHPs and additional control measures at CCPs should be
applied.
(v) Control measures that are essential to achieve an acceptable level of food safety, should be
scientifically validated1.
(vi) The application of control measures should be subject to monitoring, corrective actions, verification,
and documentation, as appropriate to the nature of the food product and the size of the food business.
(vii) Food hygiene systems should be reviewed to determine if modifications are needed. This should be
done periodically and whenever there is a significant change that could impact the potential hazards
and/or the control measures (e.g. new process, new ingredient, new product, new equipment, new
scientific knowledge) associated with the food business.
(viii) Appropriate communication about the food and food process should be maintained among all relevant
parties to ensure food safety and suitability across the entire food chain.
Management Commitment to Food Safety
Fundamental to the successful functioning of any food hygiene system is the establishment and maintenance
of a positive food safety culture acknowledging the importance of human behaviour in providing safe and
suitable food. The following elements are important in cultivating a positive food safety culture:
 commitment of the management and all personnel to the production and handling of safe food;
 leadership to set the right direction and to engage all personnel in food safety practices;
 awareness of the importance of food hygiene by all personnel in the food business;
 open and clear communication among all personnel in the food business, including communication of
deviations and expectations; and
 the availability of sufficient resources to ensure the effective functioning of the food hygiene system.
Management should ensure the effectiveness of the food hygiene systems in place by:
 ensuring that roles, responsibilities, and authorities are clearly communicated in the food business;
 maintaining the integrity of the food hygiene system when changes are planned and implemented;
 verifying that controls are carried out and working and that documentation is up to date;
 ensuring that the appropriate training and supervision are in place for personnel;
 ensuring compliance with relevant regulatory requirements; and
 encouraging continual improvement, where appropriate, taking into account developments in science,
technology and best practice.

1 Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008)
CXC 1-1969 5

DEFINITIONS
For the purposes of this document the following definitions apply:
Acceptable level: A level of hazard in a food at or below which the food is considered to be safe according to
its intended use.
Allergen cross-contact: the unintentional incorporation of an allergenic food, or ingredient, into another food
that is not intended to contain that allergenic food or ingredient.
Cleaning: The removal of soil, food residues, dirt, grease or other objectionable matter.
Competent Authority: The government authority or official body authorized by the government that is
responsible for the setting of regulatory food safety requirements and/or for the organization of official controls
including enforcement.
Contaminant: Any biological, chemical or physical agent, foreign matter or other substances not intentionally
added to food that may compromise food safety or suitability.
Contamination: The introduction or occurrence of a contaminant in the food or food environment.
Control:
 when used as a noun: The state wherein correct procedures are being followed and any established
criteria are being met.
 when used a verb: To take all necessary actions to ensure and maintain compliance with established
criteria and procedures.
Control measure: Any action or activity that can be used to prevent or eliminate a hazard or reduce it to an
acceptable level.
Corrective action: Any action taken when a deviation occurs in order to re-establish control, segregate and
determine the disposition of the affected product if any and prevent or minimize reoccurrence of the deviation.
Critical Control Point (CCP): A step at which a control measure or control measures, essential to control a
significant hazard, is/are applied in a HACCP system.
Critical limit: A criterion, observable or measurable, relating to a control measure at a CCP which separates
acceptability from unacceptability of the food.
Deviation: Failure to meet a critical limit or to follow a GHP procedure.
Disinfection: Reduction by means of biological or chemical agents and/or physical methods in the number of
viable microorganisms on surfaces, in water or air to a level that does not compromise food safety and/or
suitability.
Flow diagram: A systematic representation of the sequence of steps used in the production or manufacture
of food.
Food business operator (FBO): The entity responsible for operating a business at any step in the food chain.
Food Handler: Any person who directly handles packaged or unpackaged food, equipment and utensils used
for food, or surfaces that come into contact with food and that is expected, therefore, to comply with food
hygiene requirements.
Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at all stages
of the food chain.
Food hygiene system: Prerequisite programmes, supplemented with control measures at CCPs, as
appropriate, that when taken as a whole, ensure that food is safe and suitable for its intended use.
Food safety: Assurance that food will not cause adverse health effects to the consumer when it is prepared
and/or eaten according to its intended use.
Food suitability: Assurance that food is acceptable for human consumption according to its intended use.
Good Hygiene Practices (GHPs): Fundamental measures and conditions applied at any step within the food
chain to provide safe and suitable food.
HACCP Plan: Documentation or set of documents, prepared in accordance with the principles of HACCP to
ensure control of significant hazards in the food business.
HACCP System: The development of a HACCP plan and the implementation of the procedures in accordance
with that plan.
CXC 1-1969 6

Hazard: A biological, chemical or physical agent in food with the potential to cause an adverse health effect.
Hazard analysis: The process of collecting and evaluating information on hazards identified in raw materials
and other ingredients, the environment, in the process or in the food, and conditions leading to their presence
to decide whether or not these are significant hazards.
Monitor: The act of conducting a planned sequence of observations or measurements of control parameters
to assess whether a control measure is under control.
Primary Production: Those steps in the food chain up to and including storage and, where appropriate,
transport of outputs of farming. This would include growing crops, raising fish and animals, and the harvesting
of plants, animals or animal products from a farm or their natural habitat.
Prerequisite programme: Programmes including Good Hygiene Practices, Good Agricultural Practices and
Good Manufacturing Practices, as well as other practices and procedures such as training and traceability,
that establish the basic environmental and operating conditions that set the foundation for implementation of
a HACCP system.
Significant hazard: A hazard identified by a hazard analysis, as reasonably likely to occur at an unacceptable
level in the absence of control, and for which control is essential given the intended use of the food.
Step: A point, procedure, operation or stage in the food chain, including raw materials, from primary production
to final consumption.
Validation of control measures: Obtaining evidence that a control measure or combination of control
measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring,
to determine whether a control measure is or has been operating as intended.

CHAPTER ONE
GOOD HYGIENE PRACTICES
SECTION 1: INTRODUCTION AND CONTROL OF FOOD HAZARDS
The development, implementation and maintenance of GHPs provide the conditions and activities that are
necessary to support the production of safe and suitable food at all stages of the food chain from primary
production through to handling of the final product. Applied generally, they assist in controlling hazards in food
products.
Knowledge of the food and its production process is essential for the effective implementation of GHPs. This
Chapter provides guidance for effective implementation of GHPs, including appropriate location, layout, design,
construction and maintenance of premises and facilities, and should be applied in conjunction with sector and
product-specific codes.
GHPs manage many sources of food hazards which could contaminate food products, e.g. persons who
handle food at harvest, during manufacturing, and during preparation; raw materials and other ingredients
purchased from suppliers; cleaning and maintaining the work environment; storage and display.
As previously noted, all FBOs should be aware of and understand hazards associated with their businesses,
and the control measures required to manage these hazards, as appropriate. FBOs should consider (using
external resources as needed) whether the application of GHPs alone is sufficient to manage some or all of
the hazards associated with the operation through control of their sources, e.g.
 Control of water quality – minimizes the presence of many potential hazards (e.g. biological, chemical,
physical);
 Control of faecal contamination – minimizes the potential for contamination with many foodborne
pathogens such as Salmonella, Campylobacter, Yersinia, pathogenic strains of E.coli;
 Control of food handler practices and hygiene – prevents many potential communicable diseases that
could be foodborne; and
 Control of food contact surfaces by cleaning – removes bacterial contaminants, including foodborne
pathogens, and allergens.
 CXC 1-1969 7

After consideration of the conditions and activities in the business, it may be determined that GHPs alone may
be sufficient to manage the hazards. However, it may also be determined that it is necessary to place greater
attention on some GHPs that are particularly important for food safety (e.g. increased stringency of cleaning
of a mincer for producing minced meat for raw or lightly cooked consumption compared to equipment used for
producing meat to be cooked prior to consumption; increased monitoring and/or verification of disinfection of
food contact surfaces).
Hazards that occur or are present at levels such that GHP procedures are not sufficient to provide safe food
should be managed by an appropriate combination of control measures that are capable of preventing
occurrence of hazards or eliminating or reducing them to an acceptable level. The control measures can be
identified in one or more steps throughout the production process. In the case in which significant hazards are
identified that need to be controlled after the implementation of GHPs, it will be necessary to develop and
implement a HACCP system (see Chapter 2).
SECTION 2: PRIMARY PRODUCTION
OBJECTIVES :
Primary production should be managed in a way that ensures that food is safe and suitable for its intended
use. Where necessary, this will include:
- an assessment of the suitability of water used where it may pose a hazard, for example, crop irrigation,
rinsing activities, etc.
− avoiding the use of areas where the environment poses a threat to the safety of food (e.g. contaminated
sites);
− controlling contaminants, pests and diseases of animals and plants, to the extent practicable, to minimize
the threat to food safety (e.g. appropriate use of pesticides and veterinary drugs);
− adopting practices and measures to ensure food is produced under appropriately hygienic conditions (e.g.
cleaning and maintaining harvest equipment, rinsing, hygienic milking practices).
RATIONALE:
To reduce the likelihood of introducing a contaminant which may adversely affect the safety of food, or its
suitability for consumption, at all stages of the food chain.

The types of activities involved in primary production may make eliminating or reducing some hazards difficult.
However, by applying prerequisite programmes such as Good Agricultural Practices (GAPs) and/or GHPs,
steps can be taken to minimize the occurrence and levels of hazards in the food chain, e.g. at milking for dairy
production, steps taken in the hygienic production of eggs, or the controls on irrigation water used for growing
salad crops. Not all provisions apply for all primary production situations and consideration will need to be
given by the FBO on the appropriateness of the measures to be taken.
2.1 Environmental control
Potential sources of contamination from the environment should be identified. In particular, primary production
should not be carried out in areas where the presence of contaminants would lead to an unacceptable level of
such contaminants in food, e.g. using polluted areas 2, locating near facilities emitting toxic or offensive odours
which could taint foodstuffs or near sources of contaminated water such as discharge of waste water from
industrial production or runoff from agricultural land with high faecal material or chemical residues, unless there
is a measure to reduce or prevent the contamination of food.

2Code of Practice Concerning Source Directed Measures to Reduce Contamination of Food with Chemicals (CXC 49-
2001)
 CXC 1-1969 8

2.2 Hygienic Production

The potential effects of primary production activities on the safety and suitability of food should be considered
at all times. In particular, this includes identifying any specific points in such activities where a high probability
of contamination may exist and taking specific measures to minimize and, if possible, eliminate that probability.
Producers should as far as practicable implement measures to:
 control contamination from soil, water, feedstuffs, fertilizers (including natural fertilizers), pesticides,
veterinary drugs or any other agent used in primary production;
 protect food sources from faecal and other contamination (e.g. zoonotic foodborne agents);
 control plant and animal health so that it does not pose a threat to human health through food
consumption, or adversely affect the suitability of the product (e.g. observe the withdrawal period of
veterinary drugs and pesticides, keeping records where applicable); and
 manage waste and store harmful substances appropriately.
2.3 Handling, Storage and Transport
Procedures should be in place to:
 sort food to remove material which should not be used for human consumption;
 dispose of any rejected material in a hygienic manner; and
 protect food from contamination by pests, or by chemical, physical or microbiological contaminants or
other objectionable substances during handling (e.g. sorting, grading, washing), storage and transport.
Care should be taken to prevent deterioration and spoilage through appropriate measures which may
include controlling temperature, humidity, and/or other controls.
2.4 Cleaning, Maintenance and Personnel Hygiene
Appropriate facilities and procedures should be in place to ensure that:
 cleaning and maintenance are carried out effectively and do not compromise food safety (e.g. ensuring
equipment used in harvest is not a source of contamination); and
 an appropriate degree of personal hygiene is maintained to ensure personnel are not a source of
contamination (e.g. by human faeces).
SECTION 3: ESTABLISHMENT - DESIGN OF FACILITIES AND EQUIPMENT

OBJECTIVES:
Depending on the nature of the operations and the associated risks, premises, equipment and facilities
should be located, designed and constructed to ensure that:
• contamination is minimized;
• design and layout permit appropriate maintenance, cleaning and disinfection and minimize airborne
contamination;
• surfaces and materials, in particular those in contact with food, are non-toxic for their intended use;
• where appropriate, suitable facilities are available for temperature, humidity and other controls;
• there is effective protection against pest access and harbourage; and
• there are sufficient and appropriate washroom facilities for personnel.
RATIONALE:
Attention to good hygienic design and construction, appropriate location, and the provision of adequate
facilities is necessary to enable contaminants to be effectively controlled.
 CXC 1-1969 9

3.1 Location and structure

3.1.1 Location of establishment
Food establishments should not be located where there is a threat to food safety or suitability and hazards
cannot be controlled by reasonable measures. The location of an establishment, including temporary/mobile
establishments, should not introduce any hazards from the environment that cannot be controlled. In particular,
unless sufficient safeguards are provided, establishments should normally be located away from:
 environmentally polluted areas and industrial activities which are reasonably likely to contaminate food;
 areas subject to flooding;
 areas prone to infestations of pests; and
 areas where wastes, either solid or liquid, cannot be removed effectively.
3.1.2 Design and layout of food establishment
The design and layout of food establishments should permit adequate maintenance and cleaning. The layout
of premises and the flow of operations, including the movements of personnel and material within the buildings,
should be such that cross-contamination is minimized or prevented.
Areas having different levels of hygiene control (e.g. the raw material and finished product areas) should be
separated to minimize cross-contamination through measures such as physical separation (e.g. walls,
partitions) and/or location (e.g. distance), traffic flow (e.g. one-directional production flow), airflow, or
separation in time, with suitable cleaning and disinfection between uses.
3.1.3 Internal structures and fittings
Structures within food establishments should be soundly built of durable materials, which are easy to maintain,
clean and, where appropriate, easy to disinfect. They should be constructed of non-toxic and inert materials
according to intended use and normal operating conditions. In particular, the following specific conditions
should be satisfied where necessary to protect the safety and suitability of food:
 the surfaces of walls, partitions and floors should be made of impervious materials that are easy to
clean and, where necessary, disinfect;
 walls and partitions should have a smooth surface up to a height appropriate to the operation;
 floors should be constructed to allow adequate drainage and cleaning;
 ceilings and overhead fixtures (e.g. lighting) should be constructed to be shatterproof where
appropriate, and finished to minimize the build-up of dirt and condensation and the shedding of
particles;
 windows should be easy to clean, be constructed to minimize the build-up of dirt and, where necessary,
be fitted with removable and cleanable insect-proof screens; and
 doors should have smooth, non-absorbent surfaces, be easy to clean and, where necessary, disinfect.
Work surfaces that come into direct contact with food should be in sound condition, durable, and easy to clean,
maintain and disinfect. They should be made of smooth, non-absorbent materials, and inert to the food, to
detergents and to disinfectants under normal operating conditions.
3.1.4 Temporary/mobile food establishments and vending machines
Establishments and structures covered here include market stalls, street vending vehicles, vending machines
and temporary premises such as tents and marquees.
Such premises and structures should be located, designed and constructed to avoid, as far as reasonably
practicable, the contamination of food and the harbouring of pests. Adequate facilities for toileting and washing
hands should be provided, where appropriate.
3.2 Facilities
3.2.1 Drainage and waste disposal facilities
Adequate drainage and waste disposal systems and facilities should be provided and well maintained. They
should be designed and constructed so that the likelihood of contaminating food or the water supply is avoided.
For plumbing, steps should be taken to prevent backflow, cross-connections, and backup of sewer gases. It is
important that drainage does not flow from highly contaminated areas (such as toilets or raw production areas)
to areas where finished food is exposed to the environment.
 CXC 1-1969 10

Waste should be collected, disposed of by trained personnel and, where appropriate, disposal records
maintained. The waste disposal site should be located away from the food establishment to prevent pest
infestation. Containers for waste, by-products and inedible or hazardous substances should be specifically
identifiable, suitably constructed and, where appropriate, made of impervious material.
Containers used to hold hazardous substances prior to disposal should be identified and, where appropriate,
be lockable to prevent intentional or accidental contamination of food.
3.2.2 Cleaning facilities
Adequate, suitably designated facilities should be provided for cleaning utensils and equipment. Such facilities
should have an adequate supply of hot and/or cold water, where required. A separate cleaning area should be
provided for tools and equipment from highly contaminated areas like toilets, drainage and waste disposal
areas. Where appropriate, facilities for washing food should be separate from facilities for cleaning utensils
and equipment, and separate sinks should be available for hand washing and food washing.
3.2.3 Personnel hygiene facilities and toilets
Adequate washing and toilet facilities should be available so that an appropriate degree of personal hygiene
can be maintained and to avoid personnel contaminating food. Such facilities should be suitably located and
should not be used for other purposes such as storage of food or items that contact food. They should include:
 adequate means of washing and drying hands, including soap (preferably liquid soap), wash basins
and, where appropriate, a supply of hot and cold (or suitably temperature controlled) water;
 hand washing basins of an appropriate hygienic design, ideally with taps not operated by hands; where
this is not possible, appropriate measures to minimize contamination from the taps should be in place;
and
 suitable changing facilities for personnel, if needed.
Handwashing basins should not be used for washing food or utensils.
3.2.4 Temperature
Depending on the nature of the food operations undertaken, adequate facilities should be available for heating,
cooling, cooking, refrigerating and freezing food, for storing refrigerated or frozen foods, and, when necessary,
controlling ambient temperatures to ensure the safety and suitability of food.
3.2.5 Air quality and ventilation
Adequate means of natural or mechanical ventilation should be provided, in particular to:
 minimize air-borne contamination of food, for example, from aerosols and condensation droplets;
 help control ambient temperatures;
 control odours which might affect the suitability of food; and
 control humidity to ensure the safety and suitability of food (e.g. to prevent an increase in moisture of
dried foods that would allow growth of microorganisms and production of toxic metabolites).
Ventilation systems should be designed and constructed so that air does not flow from contaminated areas to
clean areas; the systems should be easy to maintain and clean.
3.2.6 Lighting
Adequate natural or artificial lighting should be provided to enable the food business to operate in a hygienic
manner. Lighting should be such that it does not adversely impact the ability to detect defects of, or
contaminants in, food or the examination of facilities and equipment for cleanliness. The intensity should be
adequate to the nature of the operation. Light fittings should, where appropriate, be protected to ensure that
food is not contaminated by breakages of lighting elements.
 CXC 1-1969 11

3.2.7 Storage
Adequate and, where necessary, separate facilities for the safe and hygienic storage of food products, food
ingredients, food packaging materials and non-food chemicals (including cleaning materials, lubricants, fuels),
should be provided. Storage should allow for segregation of raw and cooked foods or allergenic and non-
allergenic food.
Food storage facilities should be designed and constructed to:
 facilitate adequate maintenance and cleaning;
 avoid pest access and harbourage;
 enable food to be effectively protected from contamination, including allergen cross-contact, during
storage; and
 where necessary, provide an environment which minimizes the deterioration of food (such as by
temperature and humidity control).
The type of storage facilities required will depend on the nature of the food. Separate, secure, storage facilities
for cleaning materials and hazardous substances should be provided.
3.3 Equipment
3.3.1 General
Equipment and containers coming into contact with food should be suitable for food contact; designed,
constructed and located to ensure that they can be adequately cleaned (other than containers which are single-
use only); disinfected (where necessary); and maintained or discarded as necessary to avoid the
contamination of food, according to hygienic design principles. Equipment and containers should be made of
materials that are non-toxic according to intended use. Where necessary, equipment should be durable and
movable or capable of being disassembled to allow for maintenance, cleaning, disinfection and to facilitate
inspection for pests.
3.3.2 Food control and monitoring equipment
Equipment used to cook, heat, cool, store or freeze food should be designed to achieve the required food
temperatures as rapidly as necessary in the interests of food safety and suitability, and to maintain food
temperatures effectively.
Such equipment should also be designed to allow temperatures to be monitored, where necessary, and
controlled. Where appropriate, monitoring equipment should be calibrated to ensure that temperatures of food
processes are accurate.
Where necessary, such equipment should have effective means of controlling and monitoring humidity, air-
flow and any other characteristics likely to have an effect on the safety or suitability of food.
SECTION 4: TRAINING AND COMPETENCE

OBJECTIVE:
All those engaged in food operations who come directly or indirectly into contact with food should have
sufficient understanding of food hygiene to ensure they have competence appropriate to the operations
they are to perform.
RATIONALE:
Training is fundamentally important to any food hygiene system and the competence of personnel.
Adequate hygiene training, and/or instruction and supervision of all personnel involved in food-related
activities contribute to ensuring the safety of food and its suitability for consumption.

4.1 Awareness and Responsibilities

Food hygiene training is fundamentally important to the food business. All personnel should be aware of their
role and responsibility in protecting food from contamination or deterioration. Personnel should have the
knowledge and skills necessary to enable them to handle food hygienically. Those who handle cleaning
chemicals or other potentially hazardous chemicals should be instructed in proper use to prevent
contamination of food.
 CXC 1-1969 12

4.2 Training Programmes

Elements to take into account in determining the extent of training required include:
 the nature of hazards associated with the food, e.g. its ability to sustain growth of pathogenic or
spoilage microorganisms, the existence of potential physical contaminants or known allergens;
 the manner in which the food is produced, processed, handled and packed, including the likelihood of
contamination;
 the extent and nature of processing or further preparation before consumption of the food;
 the conditions under which the food will be stored;
 the expected length of time before consumption of the food; and
 the use and maintenance of instruments and equipment associated with food.
Training programmes should also consider the knowledge and skill levels of the personnel being trained.
Topics to be considered for training programmes could include the following as appropriate to a person’s
duties:
 the principles of food hygiene applicable to the food business;
 the measures relevant to the food business that are used to prevent contaminants in food;
 the importance of good personal hygiene, including proper hand washing and wearing, when needed,
appropriate clothing, for food safety;
 the good hygiene practices applicable to the food business.
 appropriate actions to take when food hygiene problems are observed.
In addition, for retail and food service operations, whether personnel have direct customer interaction is a
factor in training, since it may be necessary to convey certain information about products (such as allergens)
to customers.
4.3 Instruction and Supervision
The type of instruction and supervision needed will depend on the size of the business, the nature of its
activities and the types of food involved. Managers, supervisors and/or operators/workers should have
sufficient knowledge of food hygiene principles and practices to be able to identify deviations and take
necessary action as appropriate to their duties.
Periodic assessments of the effectiveness of training and instruction programmes should be made, as well as
routine supervision and verification to ensure that procedures are being carried out effectively. Personnel
tasked to perform any activities used in food control should be trained adequately to ensure that they are
competent to perform their tasks and are aware of the impact of their tasks on the safety and suitability of the
food.
4.4 Refresher Training
Training programmes should be routinely reviewed and updated where necessary. Systems should be in place
to ensure that food handlers and personnel associated with the food business, such as maintenance staff,
remain aware of all procedures necessary to maintain the safety and suitability of food. Records should be
kept of training activities.
 CXC 1-1969 13

SECTION 5: ESTABLISHMENT MAINTENANCE, CLEANING AND DISINFECTION, AND PEST CONTROL

OBJECTIVES:
To establish effective systems that:
• ensure appropriate establishment maintenance;
• ensure cleanliness and, when necessary, adequate disinfection;
• ensure pest control;
• ensure waste management; and
• monitor effectiveness of cleaning and disinfection, pest control and waste management
procedures.
RATIONALE:
To facilitate the continuing effective control of food contaminants, pests, and other agents likely to
compromise food safety and suitability.

5.1 Maintenance and Cleaning

5.1.1 General
Establishments and equipment should be maintained in an appropriate condition to:
 facilitate all cleaning and disinfection procedures;
 function as intended; and
 prevent contamination of food, such as from pests, metal shards, flaking plaster, debris, chemicals,
wood, plastic, glass, paper.
Cleaning should remove food residues and dirt which may be a source of contamination, including allergens.
The cleaning methods and materials necessary will depend on the nature of the food business, the food type
and the surface to be cleaned. Disinfection may be necessary after cleaning, especially for food contact
surfaces.
Attention should be paid to hygiene during cleaning and maintenance operations so as not to compromise
food safety and suitability. Cleaning products suitable for food contact surfaces should be used in food
preparation and storage areas.
Cleaning and disinfection chemicals should be handled and used carefully and in accordance with
manufacturers’ instructions, for example, using the correct dilutions and contact times, and stored, where
necessary, separated from food, in clearly identified containers to avoid contamination of food.
Separate cleaning equipment and utensils, suitably designated, should be used for different hygiene zones
e.g. food and non-food contact surfaces.
Cleaning equipment should be stored in an appropriate place and in such a manner to prevent contamination.
Cleaning equipment should be kept clean, maintained and replaced periodically so as not to become a source
for cross-contamination of surfaces or food.
5.1.2 Cleaning and disinfection methods and procedures
Cleaning can be carried out by the separate or the combined use of physical methods, such as heat, scrubbing,
turbulent flow, and vacuum cleaning (or other methods that avoid the use of water), and chemical methods
using solutions of detergents, alkalis or acids. Dry cleaning or other appropriate methods for removing and
collecting residues and debris may be needed in some operations and/or food processing areas where water
increases the likelihood of microbiological contamination. Care should be taken to ensure cleaning procedures
do not lead to contamination of food, e.g. spray from pressure washing can spread contamination from dirty
areas, such as floors and drains, over a wide area and contaminate food contact surfaces or exposed food.
Wet cleaning procedures will involve, where appropriate:
 removing gross visible debris from surfaces;
 applying an appropriate detergent solution to loosen soil; and
 rinsing with water (hot water where appropriate) to remove loosened material and residues of
detergent.
 CXC 1-1969 14

Where necessary, cleaning should be followed by chemical disinfection with subsequent rinsing unless the
manufacturer’s instructions indicate that, on a scientific basis, rinsing is not required. Concentrations and
application time of chemicals used for disinfection should be appropriate for use and applied according to
manufacturers’ instructions for optimal effectiveness. If cleaning is not done effectively to remove soil to permit
the disinfectant to contact microorganisms or if sub-lethal concentrations of the disinfectant are used, the
microorganisms may persist.
Cleaning and disinfection procedures should ensure that all parts of the establishment are appropriately clean.
Where appropriate, programmes should be drawn up in consultation with relevant experts.
Written cleaning and disinfection procedures should be used, where appropriate. They should specify:
 areas, items of equipment and utensils to be cleaned, and, where appropriate, disinfected;
 responsibility for particular tasks;
 method and frequency of cleaning and, where appropriate, disinfection; and
 monitoring and verification activities.
5.1.3 Monitoring of Effectiveness
Application of cleaning and disinfection procedures should be monitored for effectiveness and periodically
verified by means such as visual inspections and audits to ensure the procedures have been applied properly.
The type of monitoring will depend on the nature of the procedures, but could include pH, water temperature,
conductivity, cleaning agent concentration, disinfectant concentration, and other parameters important to
ensure the cleaning and disinfection programme is being implemented as designed and verify its effectiveness.
Microorganisms can sometimes become tolerant to disinfecting agents over time. Cleaning and disinfection
procedures should follow the manufacturers’ instructions. Periodic review with disinfectant
manufacturers/suppliers, where feasible, should be conducted to help ensure the disinfectants used are
effective and appropriate. Rotation of the disinfectants could be considered to ensure inactivation of different
types of microorganisms (e.g. bacteria and fungi).
While effectiveness of cleaning and disinfecting agents and instructions for use are validated by their
manufacturers, measures should be taken for sampling and testing the environment and food contact surfaces
(e.g. protein and allergen test swabs, or microbiological testing for indicator organisms) to help verify that
cleaning and disinfection programmes are effective and being applied properly. Microbiological sampling and
testing may not be appropriate in all cases and an alternative approach might include observation of cleaning
and disinfection procedures, including the correct disinfectant concentration, to achieve the necessary results
and to make sure protocols are being followed. Cleaning and disinfection and maintenance procedures should
be regularly reviewed and adapted to reflect any changes in circumstances and documented as appropriate.
5.2 Pest control systems
5.2.1 General
Pests (e.g. birds, rodents, insects etc.) pose a major threat to the safety and suitability of food. Pest infestations
can occur where there are breeding sites and a supply of food. GHPs should be employed to avoid creating
an environment conducive to pests. Good building design, layout, maintenance, and location, along with
cleaning, inspection of incoming materials and effective monitoring, can minimize the likelihood of infestation
and thereby limit the need for pesticides.
5.2.2 Prevention
Establishments should be kept in good repair and condition to prevent pest access and to eliminate potential
breeding sites. Holes, drains and other places where pests are likely to gain access should be covered. Roll
up doors should close tightly against the floor. Wire mesh screens, for example on open windows, doors and
ventilators, will reduce the problem of pest entry. Animals should, wherever possible, be excluded from the
grounds of food processing establishments.
5.2.3 Harbourage and infestation
The availability of food and water encourages pest harbourage and infestation. Potential food sources should
be stored in pest-proof containers and/or stacked above the ground and preferably away from walls. Areas
both inside and outside food premises should be kept clean and free of waste. Where appropriate, refuse
should be stored in covered, pest-proof containers. Any potential harbourage, such as old and unused
equipment, should be removed.
Landscaping surrounding a food establishment should be designed to minimize attracting and harbouring pests.
 CXC 1-1969 15

5.2.4 Monitoring and detection

Establishments and surrounding areas should be regularly examined for evidence of infestation. Detectors and
traps (e.g. insect light traps, bait stations) should be designed and located so as to prevent potential
contamination of raw materials, products or facilities. Even if monitoring and detection are outsourced, FBOs
should review monitoring reports and, if necessary, ensure they or their designated pest control operators take
corrective action (e.g. eradication of pests, elimination of harbourage sites or invasion routes).
5.2.5 Control of pest infestation
Pest infestations should be addressed immediately by a qualified person or company and appropriate
corrective action taken. Treatment with chemical, physical or biological agents should be carried out without
posing a threat to the safety or suitability of food. The cause of infestation should be identified, and corrective
action taken to prevent a problem from reoccurring. Records should be kept of infestation, monitoring and
eradication.
5.3 Waste management
5.3.1 General
Suitable provision should be made for the removal and storage of waste. Waste should, as far as possible, be
collected and stored in covered containers and should not be allowed to accumulate and overflow in food
handling, food storage, and other working areas or the adjoining environment in a manner that compromises
food safety and suitability. Personnel responsible for waste removal (including hazardous waste) should be
properly trained so they do not become a source of cross-contamination.
Waste storage areas should be easily identifiable, be kept appropriately clean, and be resistant to pest
infestation. They should also be located away from processing areas.
SECTION 6: PERSONAL HYGIENE

OBJECTIVES:
To ensure that those who come directly or indirectly into contact with food:
• maintain appropriate personal health;
• maintain an appropriate degree of personal cleanliness; and
• behave and operate in an appropriate manner.
RATIONALE:
Personnel who do not maintain an appropriate degree of personal cleanliness, who have certain illnesses
or conditions or who behave inappropriately, can contaminate food and transmit illness to consumers
through food.

Food businesses should establish policies and procedures for personal hygiene. FBOs should ensure all
personnel are aware of the importance of good personal hygiene and understand and comply with practices
that ensure food safety and suitability.
6.1 Health Status
Personnel known or suspected to be ill or carrying a disease likely to be transmitted through food should not
enter any food handling area if there is a likelihood of their contaminating food. Any person so affected should
immediately report illness or symptoms of illness to the management.
It may be appropriate for personnel to be excluded for a specific time after symptoms resolve or, for some
illnesses, to get medical clearance before returning to work.
6.2 Illness and Injuries
Some symptoms of illnesses that should be reported to management so that the need for possible exclusion
from food handling and/or medical examination can be considered include:
 jaundice;
 diarrhoea;
 vomiting;
 fever;
 CXC 1-1969 16

 sore throat with fever;

 visibly infected skin lesions (boils, cuts, etc.); and
 discharges from the ear, eye or nose.
Personnel with cuts and wounds should, where necessary, be assigned to work in areas where they will have
no direct contact with food. Where personnel are permitted to continue working, cuts and wounds should be
covered by suitable waterproof plasters and, where appropriate, gloves. Appropriate measures should be
applied to ensure plasters do not become a source of contamination (e.g. plasters of contrasting colour
compared to the food and/or detectable using a metal detector or x-ray detector).
6.3 Personal Cleanliness
Personnel should maintain a high degree of personal cleanliness and, where appropriate, wear suitable
protective clothing, head and beard covering, and footwear. Measures should be implemented to prevent
cross-contamination by personnel through adequate hand washing and, where necessary, the wearing of
gloves. If gloves are worn, appropriate measures should be applied to ensure the gloves do not become a
source of contamination.
Personnel, including those wearing gloves, should clean their hands regularly, especially when personal
cleanliness may affect food safety. In particular they should wash hands:
 at the start of food handling activities;
 when returning to work after breaks;
 immediately after using the toilet; and
 after handling any contaminated material, such as waste or raw and unprocessed foods where this
could result in contamination of other food items.
In order not to contaminate food, personnel should wash hands with soap and water and rinse and dry them
in a manner that does not recontaminate the hands. Hand sanitizers should not replace hand washing and
should be used only after hands have been washed.
6.4 Personal Behaviour
When engaged in food handling activities personnel should refrain from behaviour which could result in
contamination of food, for example:
 smoking or vaping;
 spitting;
 chewing, eating, or drinking;
 touching the mouth, nose or other places of possible contamination; and
 sneezing or coughing over unprotected food.
Personal effects such as jewellery, watches, pins or other items such as false nails/eye lashes should not be
worn or brought into food handling areas if they pose a threat to the safety and suitability of food.
6.5 Visitors and other persons from outside the establishment
Visitors to food businesses, including maintenance workers, in particular to food manufacturing, processing or
handling areas, should, where appropriate, be instructed and supervised, wear protective clothing and adhere
to the other personal hygiene provisions for personnel. Visitors should be guided through a hygiene policy of
the business prior to visits and encouraged to report any type of illness/injury that may pose cross-
contamination issues.
 CXC 1-1969 17

SECTION 7: CONTROL OF OPERATION

OBJECTIVES:
To produce food that is safe and suitable for human consumption by:
• formulating design requirements with respect to raw materials and other ingredients,
composition/formulation, production, processing, distribution, and consumer use to be met as
appropriate to the food business;
• designing, implementing, monitoring and reviewing effective control systems as appropriate to the
food business.
RATIONALE:
If operations are not controlled appropriately, food may become unsafe or unsuitable for consumption.

Control of operation is achieved by having an appropriate food hygiene system in place. The following section
describes practices that can assist in the identification and application of appropriate controls, as well as
activities that should take place to ensure the operation is under control.
7.1 Description of products and processes
After consideration of the conditions and activities of the food business it may be necessary to pay greater
attention to some GHPs that are particularly important for food safety. In this case, the following provisions
could be considered.
7.1.1 Product description
An FBO that is producing, storing or otherwise handling food should have a description of the food. Products
may be described individually or in groups in a manner that does not compromise the awareness of hazards
or other factors such as suitability of the products for the purpose intended. Any grouping of food products
should be based on them having similar inputs and ingredients, product characteristics (such as pH, water
activity (aw)), process steps and/or intended purpose.
The description could include, as appropriate:
 the intended use of the food, e.g. whether it is ready-to-eat or whether it is intended for further
processing either by consumers or another business, for example raw seafood to be cooked;
 products intended for specific vulnerable consumer groups e.g. infant formula or food for special
medical purposes;
 any relevant specifications e.g. ingredient composition, aw, pH, type of preservation method used (if
any), or important characteristics associated with the food, such as any allergens present;
 any relevant limits established for the food by the competent authority or, in the absence thereof, set
by the FBO;
 instructions provided for further use, for example keep frozen until cooking, cook to a specified
temperature for a specified length of time, product shelf-life (use-by date);
 storage of product (e.g. refrigerated/frozen/shelf stable) and transport conditions required; and
 food packaging material used.
7.1.2 Process description
The FBO should consider all steps in the operation for a specific product. It may be helpful to develop a flow
diagram, which shows the sequence and interaction of all processing steps in the operation, including where
raw materials, ingredients and intermediate products enter the flow and where intermediate products, by-
products and waste are released or removed. The flow diagram could be used for a number of similar food
products that are produced using similar production or processing steps, to ensure all steps are captured. The
steps should be confirmed as accurate by an on-site review of the operation or process. For example, for
restaurants the flow diagram could be based on the general activities from the receipt of ingredients/raw
material, storage (refrigerated, frozen, room temperature), preparation before use (washing, defrosting), and
cooking or preparation of food.
 CXC 1-1969 18

7.1.3 Consideration of the effectiveness of GHPs

Having considered the product and process descriptions, an FBO should determine (using information relevant
to hazards and controls from various sources as appropriate) whether the GHPs and other programmes they
have in place are sufficient to address food safety and suitability or if some GHPs need greater attention. For
example, a cooked meat slicer may require specific and more frequent cleaning to prevent the build-up of
Listeria spp. on its meat contact surfaces, or a conveyor belt used in direct contact with the food, such as in
sandwich production, may require an increased frequency of cleaning or a specific cleaning programme. When
such increased attention on GHPs is insufficient to ensure food safety, it will be necessary to implement a
HACCP system (Chapter 2).
7.1.4 Monitoring and corrective action
The FBO should monitor the hygienic procedures and practices as relevant to the business and as applicable
to the hazard being controlled. Procedures could include defining methods of monitoring (including defining
responsible personnel, frequency and sampling regime if applicable) and monitoring records to be kept. The
frequency of monitoring should be appropriate to ensure consistent process control.
When monitoring results indicate a deviation, the FBO should undertake corrective action. Corrective action
should consist of the following actions, as appropriate:
 bringing the process back into control by, for example, altering temperature or timing, or concentration
of disinfectant;
 isolating any affected product and evaluating its safety and/or suitability;
 determining proper disposition of affected product that is not acceptable to market;
 identifying the cause that resulted in the deviation; and
 taking steps to prevent reoccurrence.
Records of corrective actions should be retained.
7.1.5 Verification
The FBO should undertake verification activities as relevant to the business, to check that GHP procedures
have been implemented effectively, monitoring is occurring, where planned, and that appropriate corrective
actions are taken when requirements are not met. Examples of verification activities could include the following,
as appropriate:
 review of GHP procedures, monitoring, corrective actions and records;
 review when any changes occur to the product, process and other operations associated with the
business; and
 assessment of the efficacy of cleaning.
Records of GHP verification activities should be kept, where appropriate.
7.2 Key aspects of GHPs
Some key aspects of GHPs such as those described in Sections 7.2.1. and 7.2.2, could be considered as
control measures applied at CCPs in the HACCP system.
7.2.1 Time and temperature control
Inadequate time and temperature control, e.g. during cooking, cooling, processing and storage, are among the
most common failures of operational control. These allow survival or growth of microorganisms that may cause
foodborne illness or food spoilage. Systems should be in place to ensure that temperature is controlled
effectively where it impacts the safety and suitability of food.
Time and temperature control systems should take into account:
 the nature of the food, e.g. its aw, pH, and likely initial level and types of microorganisms, such as
pathogenic and spoilage microflora;
 the impact on the microorganisms, e.g. time in growth/dangerous temperature zone;
 the intended shelf-life of the product;
 the method of packaging and processing; and
 how the product is intended to be used, e.g. further cooking/processing or ready-to-eat.
 CXC 1-1969 19

Such systems should also specify tolerable limits for time and temperature variations. Temperature control
systems that impact safety and suitability of food should be validated, and as appropriate, monitored and
recorded. Temperature monitoring and recording devices should be checked for accuracy and calibrated at
regular intervals or as needed.
7.2.2 Specific process steps
There are many individual processing steps for specific foods which contribute to the production of safe and
suitable food products. These vary depending on the product and can include key steps such as cooking,
chilling, freezing, drying and packaging.
The composition of a food can be important in preventing microbial growth and toxin production, e.g. in its
formulation by adding preservatives, including acids, salts, food additives or other compounds. When
formulation is used to control foodborne pathogens (e.g. adjusting the pH or aw to a level that prevents growth),
systems should be in place to ensure that the product is formulated correctly and that the controlling
parameters are monitored.
7.2.3 Microbiological3, physical, chemical and allergen specifications
Where microbiological, physical, chemical and allergen specifications are used for food safety or suitability,
such specifications should be based on sound scientific principles and state, where appropriate, sampling
parameters, analytical methods, acceptable limits and monitoring procedures. Specifications can help ensure
that raw materials and other ingredients are fit for purpose and contaminants have been minimized.
7.2.4 Microbiological contamination
Systems should be in place to prevent or minimize contamination of foods by microorganisms. Microbiological
contamination occurs through a number of mechanisms, including the transfer of microorganisms from one
food to another, e.g.:
 by direct contact or indirectly by food handlers;
 by contact with surfaces;
 from cleaning equipment;
 by splashing; or
 by airborne particles.
Raw, unprocessed food, where not considered ready-to-eat, which could be a source of contamination, should
be separated from ready-to-eat foods, either physically or by time, with effective intermediate cleaning and,
where appropriate, effective disinfection.
Surfaces, utensils, equipment, fixtures and fittings should be thoroughly cleaned and where necessary
disinfected after raw food preparation, particularly when raw materials with a potentially high microbiological
load such as meat, poultry, and fish have been handled or processed.
In some food operations, access to processing areas may need to be restricted or controlled for food safety
purposes. For example, where the likelihood of product contamination is high, access to processing areas
should be via a properly designed changing facility. Personnel may be required to put on clean protective
clothing (which may be of a differentiating colour from that worn in other parts of the facility), including head
and beard covering, footwear, and to wash their hands and where necessary sanitize them.
7.2.5 Physical contamination
Systems should be in place throughout the food chain to prevent contamination of foods by extraneous
materials, such as personnel belongings, especially any hard or sharp object(s), e.g. jewellery, glass, metal
shards, bone(s), plastic, wood fragments, that could cause injury or present a choking hazard. In manufacturing
and processing, suitable prevention strategies such as maintenance and regular inspection of equipment,
should be undertaken. Detection or screening devices which are appropriately calibrated should be used where
necessary (e.g. metal detectors, x-ray detectors). Procedures should be in place for personnel to follow in the
case of breakages (e.g. breakage of glass or plastic containers).

3Refer to the Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods
(CXG 21- 1997).
 CXC 1-1969 20

7.2.6 Chemical contamination

Systems should be in place to prevent or minimize contamination of foods by harmful chemicals, e.g. cleaning
materials, non-food grade lubricants, chemical residues from pesticides and veterinary drugs such as
antibiotics. Toxic cleaning compounds, disinfectants, and pesticide chemicals should be identified, safely
stored and used in a manner that protects against contamination of food, food contact surfaces, and food
packaging materials. Food additives and food processing aids that may be harmful if used improperly should
be controlled so they are only used as intended.
7.2.7 Allergen Management4
Systems should be in place to take into account the allergenic nature of some foods, as appropriate to the
food business. Presence of allergens, e.g. tree nuts, milk, eggs, crustacea, fish, peanuts, soybeans and wheat
and other cereals containing gluten and their derivatives (not an inclusive list; allergens of concern differ among
countries and populations), should be identified in raw materials, other ingredients and products. A system of
allergen management should be in place at receipt, during processing and storage to address the known
allergens. This management system should include controls put in place to prevent the presence of allergens
in foods where they are not labelled. Controls to prevent cross-contact from foods containing allergens to other
foods should be implemented, e.g. separation either physically or by time (with effective cleaning between
foods with different allergen profiles). Food should be protected from unintended allergen cross-contact by
cleaning and line change-over practice and/or product sequencing. Where cross-contact cannot be prevented
despite well-implemented controls, consumers should be informed. Where necessary food handlers should
receive specific training on allergen awareness and associated food manufacturing/processing practices and
preventive measures to reduce the risk to allergic consumers.
7.2.8 Incoming Materials
Only raw materials and other ingredients that are fit for purpose should be used. Incoming materials including
food ingredients should be procured according to specifications, and their compliance with food safety and
suitability specifications should be verified where necessary. Supplier quality assurance activities, such as
audits, may be appropriate for some ingredients. Raw materials or other ingredients should, where appropriate,
be inspected (e.g. visual examination for packages damaged during transportation, use-by-date and declared
allergens, or temperature measurement for refrigerated and frozen foods) for appropriate action before
processing. Where appropriate, laboratory tests could be conducted to check food safety and suitability of raw
materials or ingredients. These tests may be conducted by a supplier that provides a Certificate of Analysis,
the purchaser, or both. No incoming material should be accepted by an establishment if it is known to contain
chemical, physical or microbiological contaminants which would not be reduced to an acceptable level by
controls applied during sorting and/or processing where appropriate. Stocks of raw materials and other
ingredients should be subject to effective stock rotation. Documentation of key information for incoming
materials (e.g. supplier details, date of receipt, quantity etc.) should be maintained.
7.2.9 Packaging
Packaging design and materials should be safe and suitable for food use, provide adequate protection for
products to minimize contamination, prevent damage, and accommodate proper labelling. Packaging materials
or gases where used should not contain toxic contaminants and not pose a threat to the safety and suitability
of food under the specified conditions of storage and use. Any reusable packaging should be suitably durable,
easy to clean and, where necessary, to disinfect.
7.3 Water
Water, as well as ice and steam made from water, should be fit for its intended purpose based on a risk-based
approach5. They should not cause contamination of food. Water and ice should be stored and handled in a
manner that does not result in their becoming contaminated, and the generation of steam that will contact food
should not result in its contamination. Water that is not fit for use in contact with food (e.g. some water used
for fire control and for steam that will not directly contact food) should have a separate system that does not
connect with or allow reflux into the system for water that will contact food. Water recirculated for reuse and
water recovered from e.g. food processing operations, by evaporation and/or filtration should be treated where
necessary to ensure that the water does not compromise the safety and suitability of food.

4 See the Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020)
5 Microbiological Risk Assessment Series 33: Safety and Quality of Water Used in Food Production and Processing
 CXC 1-1969 21

7.4 Documentation and Records

Appropriate records for the food business operation should be retained for a period that exceeds the shelf-life
of the product or as determined by the competent authority.
7.5 Recall Procedures - removal from the market of unsafe food
FBOs should ensure effective procedures are in place to respond to failures in the food hygiene system.
Deviations should be assessed for the impact on food safety or suitability. Procedures should enable the
comprehensive, rapid and effective identification, and removal from the market by the involved FBO(s) and/or
return to the FBO by the consumers of any food that may pose a risk to public health. Where a product has
been recalled because of the likely presence of hazards that may represent an immediate health risk, other
products which are produced under similar conditions which may also present a hazard to public health should
be evaluated for safety and may need to be recalled. Reporting to the relevant competent authority should be
required and public warnings considered where product may have reached consumers and when return of
product to the FBO or removal from the market is appropriate. Recall procedures should be documented,
maintained, and modified where necessary based on the findings of periodic field trials.
Provision should be made for removed or returned products to be held under secure conditions until they are
destroyed, used for purposes other than human consumption, determined to be safe for human consumption,
or reprocessed in a manner to reduce the hazard to acceptable levels, where permitted by the competent
authority. The cause and extent of a recall and the corrective actions taken should be retained by the FBO as
documented information.
SECTION 8: PRODUCT INFORMATION AND CONSUMER AWARENESS

OBJECTIVES:
Appropriate information about food should ensure that:
• adequate and accessible information is available to the next FBO in the food chain or the consumer
to enable them to handle, store, process, prepare and display the product safely and correctly;
• consumers can identify allergens present in foods; and
• the lot or batch can be easily identified and removed/returned if necessary.
Consumers should be given enough information on food hygiene to enable them to:
• be aware of the importance of reading and understanding the label;
• make informed choices appropriate to the individual, including about allergens; and
• prevent contamination and growth or survival of foodborne pathogens by storing, preparing and
using food correctly.
RATIONALE:
Insufficient product information, and/or inadequate knowledge of general food hygiene, can lead to products
being mishandled at later stages in the food chain. Such mishandling can result in illness, or products
becoming unsuitable for consumption, even where adequate hygiene control measures have been
implemented earlier in the food chain. Insufficient product information about the allergens in food can also
result in illness or potentially death for allergic consumers.

8.1 Lot Identification and Traceability

Lot identification or other identification strategies are essential in product recall and also help effective stock
rotation. Each container of food should be permanently marked to identify the producer and the lot. The
General Standard for the Labelling of Prepackaged Foods (CXS 1-1985) applies.
A traceability/product tracing system should be designed and implemented according to the Principles for
Traceability/Product Tracing as a Tool within a Food Inspection and Certification System (CXG 60-2006),
especially to enable the recall of the products, where necessary.
8.2 Product Information
All food products should be accompanied by or bear adequate information to enable the next FBO in the food
chain or the consumer to handle, prepare, display, store, and/or use the product safely and correctly.
 CXC 1-1969 22

8.3 Product Labelling

Prepackaged foods should be labelled with clear instructions to enable the next person in the food chain to
handle, display, store and use the product safely. This should also include information that identifies food
allergens in the product as ingredients or where cross-contact cannot be excluded. The General Standard for
the Labelling of Prepackaged Foods (CXS 1-1985) applies.
8.4 Consumer Education
Consumer education programmes should cover general food hygiene. Such programmes should enable
consumers to understand the importance of any product label information and following any instructions
accompanying products, and to make informed choices. In particular, consumers should be informed of the
relationship between time/temperature control, cross contamination and foodborne illness, and of the presence
of allergens. Consumers should also be informed of the WHO 5 Keys to Safer Food and educated to apply
appropriate food hygiene measures (e.g. proper hand washing, adequate storage and cooking and avoiding
cross contamination) to ensure that their food is safe and suitable for consumption.
SECTION 9: TRANSPORTATION

OBJECTIVES:
During transportation, measures should be taken where necessary to:
• protect food from potential sources of contamination, including allergen cross- contact;
• protect food from damage likely to render the food unsuitable for consumption; and
• provide an environment which effectively controls the growth of pathogenic or spoilage micro-
organisms and the production of toxins in food.
RATIONALE:
Food may become contaminated or may not reach its destination in a suitable condition for consumption,
unless effective hygiene practices are taken prior to and during transport, even where adequate hygiene
practices have been taken earlier in the food chain.

9.1 General
Food should be adequately protected during transport 6 . The type of conveyances or containers required
depends on the nature of the food and the most appropriate conditions under which it should be transported.
9.2 Requirements
Where necessary, conveyances and bulk containers should be designed and constructed so that they:
 do not contaminate foods or packaging;
 can be effectively cleaned and, where necessary, disinfected and dried;
 permit effective separation of different foods or foods from non-food items that could cause
contamination where necessary during transport;
 provide effective protection from contamination, including dust and fumes;
 can effectively maintain the temperature, humidity, atmosphere and other conditions necessary to
protect food from harmful or undesirable microbial growth and deterioration likely to render it unsafe
or unsuitable for consumption; and
 allow any necessary temperature, humidity and other environmental conditions to be checked.
9.3 Use and Maintenance
Conveyances and containers for transporting food should be kept in an appropriate state of cleanliness, repair
and condition. Containers and conveyances for bulk food transport should be designated and marked for food
use and used only for that purpose, unless controls are taken to ensure that the safety and suitability of the
food are not compromised.
Where the same conveyance or container is used for transporting different foods, or non-foods, effective
cleaning and, where necessary, disinfection, and drying should take place between loads.

6 Code of Hygienic Practice for the Transport of Food in Bulk and Semi-Packed Food (CXC 47-2001)
CXC 1-1969 23

CHAPTER TWO
HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS
APPLICATION
INTRODUCTION
The first section of this Chapter sets out the seven principles of the Hazard Analysis and Critical Control Point
(HACCP) system. The second section provides general guidance for the application of the HACCP system
and the third section describes its application in 12 successive steps (Diagram 1), while recognizing that the
details of application may vary and a more flexible approach to application may be appropriate depending on
the circumstances and the capabilities of the food business operation. The HACCP system, which is science-
based and systematic, identifies specific hazards and measures for their control to ensure the safety of food.
HACCP is a tool to assess hazards and establish control systems that focus on control measures for significant
hazards along the food chain, rather than relying mainly on end-product testing. Development of a HACCP
system may identify the need for changes in processing parameters, in processing steps, in manufacturing
technology, in end product characteristics, in method of distribution, in the intended use or in the GHPs applied.
Any HACCP system should be capable of accommodating change, such as advances in equipment design,
processing procedures or technological developments.
HACCP principles can be considered throughout the food chain from primary production to final consumption,
and their implementation should be guided by scientific evidence of risks to human health. Although it is not
always feasible to apply HACCP at primary production, some of the principles can be applied and may be
incorporated into good practices programmes (e.g. Good Agricultural Practices (GAPs), etc.). It is recognised
that implementation of HACCP may be challenging for some businesses. However, HACCP principles can be
applied flexibly in individual operations, and businesses may use external resources (e.g. consultants) or adapt
a generic HACCP plan provided by the competent authority, academia or other competent bodies (e.g. trade
or industry associations) to the specific site circumstances. As well as enhancing food safety, implementation
of HACCP can provide other significant benefits, such as more efficient processes based on a thorough
analysis of capability, more effective use of resources by focusing on critical areas, and fewer recalls through
identification of problems before product is released. In addition, the application of HACCP systems can aid
review by competent authorities and promote international trade by increasing confidence in food safety.
The successful application of HACCP requires the commitment and involvement of management and
personnel and the knowledge and/or training in its application for the particular type of food business. A multi-
disciplinary approach is strongly recommended; this multi-disciplinary approach should be appropriate to the
food business operation and may include, for example, expertise in primary production, microbiology, public
health, food technology, environmental health, chemistry and engineering, according to the particular
application.
SECTION 1: PRINCIPLES OF THE HACCP SYSTEM
The HACCP system is designed, validated and implemented in accordance with the following seven principles:
PRINCIPLE 1
Conduct a hazard analysis and identify control measures.
PRINCIPLE 2
Determine the Critical Control Points (CCPs).
PRINCIPLE 3
Establish validated critical limits.
PRINCIPLE 4
Establish a system to monitor control of CCPs.
PRINCIPLE 5
Establish the corrective actions to be taken when monitoring indicates a deviation from a critical limit at a CCP
has occurred.
PRINCIPLE 6
Validate the HACCP plan and then establish procedures for verification to confirm that the HACCP system is
working as intended.
PRINCIPLE 7
Establish documentation concerning all procedures and records appropriate to these principles and their
application.
 CXC 1-1969 24

SECTION 2: GENERAL GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM

2.1 Introduction
Prior to application of a HACCP system by any FBO in the food chain, that FBO should have in place
prerequisite programmes, including GHPs established in accordance with Chapter One of this document, the
appropriate product and sector-specific Codex Codes of Practice, and in accordance with relevant food safety
requirements set by competent authorities. Prerequisite programmes should be well-established, fully
operational and verified, where possible, in order to facilitate the successful application and implementation of
the HACCP system. HACCP application will not be effective without prior implementation of prerequisite
programmes including GHPs.
For all types of food businesses, management awareness and commitment to food safety are necessary for
implementation of an effective HACCP system. The effectiveness will also rely upon management and
personnel having the appropriate HACCP training and competency. Therefore, ongoing training is necessary
for all levels of personnel, including managers, as appropriate to the food business.
A HACCP system identifies and enhances control of significant hazards, where necessary, over that achieved
by the GHPs that have been applied by the establishment. The intent of the HACCP system is to focus control
at Critical Control Points (CCPs). By specifying critical limits for control measures at CCPs and corrective
actions when limits are not met, and by producing records that are reviewed before product release, HACCP
provides consistent and verifiable control beyond that achieved by GHPs.
A HACCP approach should be customized to each food business. Hazards, control measures at CCPs and
their critical limits, CCP monitoring, CCP corrective actions and verification activities can be distinctive for a
particular situation and those identified in a Codex Code of Practice or other appropriate guidelines might not
be the only ones identified for a specific application or might be of a different nature.
The HACCP system should be reviewed periodically and whenever there is a significant change that could
impact the potential hazards and/or the control measures (e.g. new process, new ingredient, new product, new
equipment) associated with the food business. Periodic review should also be conducted when the application
of the HACCP principles has resulted in a determination that no CCPs are needed, in order to assess whether
the need for CCPs has changed.
2.2 Flexibility for small and/or less developed food businesses 7
The application of the HACCP principles to develop an effective HACCP system should be the responsibility
of each individual business. However, it is recognised by competent authorities and FBOs that there may be
obstacles that hinder the effective application of the HACCP principles by individual food businesses. This is
particularly relevant in small and/or less developed food businesses. Barriers to the application of HACCP in
small and less developed businesses (SLDBs) have been acknowledged and flexible approaches to the
implementation of HACCP in such businesses are available and encouraged. Some approaches may provide
ways to adapt the HACCP approach to assist competent authorities in supporting SLDBs, for example,
development of a HACCP-based system which is consistent with the seven principles of HACCP but does not
conform to the layout or steps described in this chapter. While it is recognized that flexibility appropriate to the
business is important when applying HACCP, all seven principles should be considered in developing the
HACCP system. This flexibility should take into account the nature of the operation, including the human and
financial resources, infrastructure, processes, knowledge and practical constraints, as well as the risk
associated with the produced food. Applying such flexibility e.g. recording only monitoring results when there
is a deviation instead of every monitoring result to reduce unnecessary burden of record keeping for certain
types of FBOs, is not intended to impact negatively on the efficacy of the HACCP system and should not
endanger food safety.
Small and/or less developed food businesses do not always have the resources and the necessary expertise
on site for the development and implementation of an effective HACCP system. In such situations, expert
advice should be obtained from other sources, which may include trade and industry associations, independent
experts and competent authorities. HACCP literature and especially sector-specific HACCP guides can be
valuable. HACCP guidance developed by experts relevant to the process or type of operation may provide a
useful tool for businesses in designing and implementing a HACCP plan. Where businesses are using expertly
developed HACCP guidance, it is essential that it is specific to the foods and/or processes under consideration.
A comprehensive explanation of the basis for the HACCP plan should be provided to the FBO. The FBO is
ultimately responsible for elaboration and implementation of the HACCP system and the production of safe
food.
The efficacy of any HACCP system will nevertheless rely on management and personnel having the

7 FAO/WHO Guidance to governments on the application of HACCP in small and/or less-developed food businesses.
 CXC 1-1969 25

appropriate HACCP knowledge and skills, therefore ongoing training is necessary for all levels of personnel,
including managers, as appropriate to the food business.
SECTION 3: APPLICATION
3.1 Assemble HACCP Team and Identify Scope (Step 1)
The FBO should ensure that the appropriate knowledge and expertise are available for the development of an
effective HACCP system. This may be achieved by assembling a multidisciplinary team responsible for
different activities within the operation, e.g. production, maintenance, quality control, cleaning and disinfection.
The HACCP team is responsible for developing the HACCP plan.
Where relevant expertise is not available in house, expert advice should be obtained from other sources, such
as trade and industry associations, independent experts, competent authorities, HACCP literature and HACCP
guides (including sector-specific HACCP guides). It may be possible that a well-trained individual with access
to such guidance is able to implement a HACCP System in house. A generic HACCP plan developed externally
may be used by FBOs where appropriate but should be tailored to the food operation.
The HACCP team should identify the scope of the HACCP system and applicable prerequisite programmes.
The scope should describe which food products and processes are covered.
3.2 Describe product (Step 2)
A full description of the product should be developed, including relevant safety information such as composition
(i.e. ingredients), physical/chemical characteristics (e.g. a w, pH, preservatives, allergens), processing
methods/technologies (heat-treatment, freezing, drying, brining, smoking, etc.), packaging, durability/shelf life,
storage conditions and method of distribution. Within businesses with multiple products, it may be effective to
group products with similar characteristics and processing steps for the purpose of development of the HACCP
plan. Any limits relevant to the food product already established for hazards should be considered and
accounted for in the HACCP plan, e.g. limits for food additives, regulatory microbiological criteria, maximum
allowed veterinary medicines residues, and times and temperatures for heat treatments prescribed by
competent authorities.
3.3 Identify intended use and users (Step 3)
Describe the use intended by the FBO and the expected uses of the product by the next FBO in the food chain
or the consumer; the description may be influenced by external information, e.g. from the competent authority
or other sources on ways in which consumers are known to use the product other than those intended by the
FBO. In specific cases (e.g. hospitals), vulnerable groups of the population may have to be considered. Where
foods are being produced specifically for a vulnerable population, it may be necessary to enhance process
controls, monitor control measures more frequently, verify controls are effective by testing products, or conduct
other activities to provide a high level of assurance that the food is safe for the vulnerable population.
3.4 Construct flow diagram (Step 4)
A flow diagram that covers all steps in the production of a specific product, including any applicable rework,
should be constructed. The same flow diagram may be used for a number of products that are manufactured
using similar processing steps. The flow diagram should indicate all inputs, including those of ingredients and
food contact materials, water and air if relevant. Complex manufacturing operations can be broken down into
smaller, more manageable modules and multiple flow diagrams that link together can be developed. The flow
diagrams should be used when conducting the hazard analysis as a basis for evaluating the possible
occurrence, increase, decrease or introduction of hazards. Flow diagrams should be clear, accurate and
sufficiently detailed to the extent needed to conduct the hazard analysis. Flow diagrams should, as appropriate,
include but not be limited to the following:
 the sequence and interaction of the steps in the operation;
 where raw materials, ingredients, processing aids, packaging materials, utilities and intermediate
products enter the flow;
 any outsourced processes;
 where applicable reworking and recycling take place;
 where end products, intermediate products, waste and by-products are released or removed.
3.5 On-site confirmation of flow diagram (Step 5)
Steps should be taken to confirm the processing activities against the flow diagram during all stages and hours
of operation and amend the flow diagram where appropriate. The confirmation of the flow diagram should be
performed by a person or persons with sufficient knowledge of the processing operation.
 CXC 1-1969 26

3.6 List all potential hazards that are likely to occur and associated with each step, conduct a hazard
analysis to identify the significant hazards, and consider any measures to control identified hazards
(Step 6/ Principle 1)
Hazard analysis consists of identifying potential hazards and evaluating these hazards to determine which of
them are significant for the specific food business operation. An example of a hazard analysis worksheet is
provided in Diagram 2. The HACCP team should list all potential hazards. The HACCP team should then
identify where these hazards are reasonably likely to occur at each step (including all inputs into that step)
according to the scope of the food business operation. Hazards should be specific, e.g. metal fragments, and
the source or reason for presence should be described, e.g. metal from broken blades after chopping. The
hazard analysis can be simplified by breaking down complex manufacturing operations and analysing steps in
the multiple flow diagrams described in step 4.
The HACCP team should next evaluate the hazards to identify which of these hazards are such that their
prevention, elimination, or reduction to acceptable levels is essential to the production of safe food (i.e.,
determine the significant hazards that have to be addressed in the HACCP plan).
In conducting the hazard analysis to determine whether there are significant hazards, wherever possible the
following should be considered:
 hazards associated with producing or processing the type of food, including its ingredients and process
steps (e.g. from surveys or sampling and testing of hazards in the food chain, from recalls, from
information in the scientific literature or from epidemiological data);
 the likelihood of occurrence of hazards, taking into consideration prerequisite programs, in the absence
of additional control;
 the likelihood and severity of adverse health effects associated with the hazards in the food in the
absence of control8;
 identified acceptable levels of the hazards in the food e.g. based on regulation, intended use, and
scientific information;
 the nature of the facility and the equipment used in making the food product;
 survival or multiplication of pathogenic microorganisms;
 production or persistence in foods of toxins (e.g. mycotoxins), chemicals (e.g. pesticides, drug residues,
allergens) or physical agents (e.g. glass, metal);
 the intended use and/or probability of product mishandling by potential consumers that could render
the food unsafe; and,
 conditions leading to the above.
The hazard analysis should consider not only the intended use, but also any known unintended use (e.g. a
soup mix intended to be mixed with water and cooked but known to commonly be used without a heat treatment
in flavouring a dip for chips) to determine the significant hazards to be addressed in the HACCP plan. (See
Diagram 2 for an example of a hazard analysis worksheet.)
In some cases, it may be acceptable for a simplified hazard analysis to be carried out by FBOs. This simplified
process identifies groups of hazards (biological, physical, chemical) in order to control the sources of these
hazards without the need for a comprehensive hazard analysis that identifies the specific hazards of concern.
There can be drawbacks to such an approach, as the controls can differ for hazards within a group, e.g.
controls for pathogenic spore-formers versus vegetative cells of microbial pathogens. Generic HACCP-based
tools and guidance documents provided by external sources, for example, by industry or competent authorities,
are designed to assist with this step and mitigate concerns about different controls needed for hazards within
a group.
Hazards which are such that their prevention, elimination or reduction to acceptable levels is essential to the
production of safe food (because they are reasonably likely to occur in the absence of control and reasonably
likely to cause illness or injury if present) should be identified and controlled by measures designed to prevent
or eliminate these hazards or reduce them to an acceptable level. In some cases, this may be achieved with
the application of good hygiene practices, some of which may target a specific hazard (for example, cleaning
equipment to control contamination of ready-to-eat foods with Listeria monocytogenes or to prevent food
allergens being transferred from one food to another food that does not contain that allergen). In other
instances, control measures will need to be applied within the process, e.g. at critical control points.

8FBOs may take advantage of risk assessments and risk management matrices established by a competent authority or
by international expert groups such as JEMRA.
 CXC 1-1969 27

Consideration should be given to what control measures, if any exist, can be applied to each hazard. More
than one control measure may be required to control a specific hazard. For example, to control L.
monocytogenes, a heat treatment may be needed to kill the organism in the food and cleaning and disinfection
may be needed to prevent transfer from the processing environment. More than one hazard may be controlled
by a specified control measure. For example, a heat treatment can control both Salmonella and E. coli O157:H7
when they are present as hazards in the food.
3.7 Determine the Critical Control Points (Step 7/ Principle 2)
The FBO should consider which among the available control measures listed during step 6, Principle 1 should
be applied at a CCP. Critical Control points are to be determined only for hazards identified as significant as
of the result of a hazard analysis. CCPs are established at steps where control is essential and where a
deviation could result in the production of a potentially unsafe food. The control measures at CCPs should
result in an acceptable level of the hazard being controlled. There may be more than one CCP in a process at
which control is applied to address the same hazard (e.g. the cook step may be the CCP for killing the
vegetative cells of a pathogenic spore-former, but the cooling step may be a CCP to prevent germination and
growth of the spores). Similarly, a CCP may control more than one hazard (e.g. cooking can be a CCP that
addresses several microbial pathogens). Determining whether or not the step at which a control measure is
applied is a CCP in the HACCP system can be helped by using a decision tree. A decision tree should be
flexible, given whether it is for use in production, slaughter, processing, storage, distribution or other processes.
Other approaches such as expert consultation may be used.
To identify a CCP, whether using a decision tree or other approach, the following should be considered:
 Assess whether the control measure can be used at the process step being analysed:
o If the control measure cannot be used at this step, then this step should not be considered as a
CCP for the significant hazard.
o If the control measure can be used at the step being analysed, but can also be used later in the
process, or there is another control measure for the hazard at another step, the step being
analysed should not be considered as a CCP.
 Determine whether a control measure at a step is used in combination with a control measure at
another step to control the same hazard; if so, both steps should be considered as CCPs.
The CCPs identified could be summarized in tabular format e.g. the HACCP worksheet presented in diagram 3,
as well as highlighted at the appropriate step on the flow diagram.
If no control measures exist at any step for an identified significant hazard, then the product or process should
be modified.
Establish validated critical limits for each CCP (Step 8/ Principle 3)
Critical limits establish whether a CCP is in control, and in doing so they can be used to separate acceptable
products from unacceptable ones. These critical limits should be measurable or observable. In some cases,
more than one parameter could have a critical limit designated at a particular step (e.g. heat treatments
commonly include critical limits for both time and temperature). Criteria often used include minimum and/or
maximum values for critical parameters associated with the control measure such as measurements of
temperature, time, moisture level, pH, aw, available chlorine, contact time, conveyor belt speed, viscosity,
conductance, flow rate, or, where appropriate, parameters that can be observed, such as a pump setting. A
deviation from the critical limit indicates that it is likely that unsafe food has been produced.
Critical limits for control measures at each CCP should be specified and scientifically validated to obtain
evidence that they are capable of controlling hazards to an acceptable level if properly implemented 9 .
Validation of critical limits may include conducting studies (e.g. microbiological inactivation studies). FBOs may
not always need to conduct or commission studies themselves to validate critical limits. Critical limits could be
based on existing literature, regulations or guidance from competent authorities, or studies carried out by a
third party e.g. studies conducted by an equipment manufacturer to determine the appropriate time,
temperature and bed depth for dry roasting tree nuts. Validation of control measures is further described more
fully in the Guidelines for the Validation of Food Safety Control Measures (CXG 69 – 2008).

9 Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008).
 CXC 1-1969 28

3.9 Establish a Monitoring System for Each CCP (Step 9/ Principle 4)

Monitoring of CCPs is the scheduled measurement or observation at a CCP relative to its critical limits. The
monitoring procedures should be able to detect a deviation at the CCP. Further, the monitoring method and
frequency should be capable of timely detection of any failure to remain within critical limits, to allow timely
isolation and evaluation of the product. Where possible, process adjustments should be made when monitoring
results indicate a trend towards a deviation at a CCP. The adjustments should be taken before a deviation
occurs.
Monitoring procedures for CCPs should be capable of timely detection of a deviation from the critical limit to
allow isolation of the affected products. The method and frequency of monitoring should take into account the
nature of the deviation (e.g. a drop in temperature or a broken sieve, rapid drop in temperature during
pasteurization, or a gradual increase in temperature in cold storage). Where possible, monitoring of CCPs
should be continuous. Monitoring of measurable critical limits such as processing time and temperature can
often be monitored continuously. Other measurable critical limits such as moisture level and preservative
concentration cannot be monitored continuously. Critical limits that are observable, such as a pump setting or
applying the correct label with appropriate allergen information are rarely monitored continuously. If monitoring
is not continuous, then the frequency of monitoring should be sufficient to ensure to the extent possible the
critical limit has been met and limit the amount of product impacted by a deviation. Physical and chemical
measurements are usually preferred to microbiological testing because physical and chemical tests can be
done rapidly and can often indicate the control of microbial hazards associated with the product and/or the
process.
The personnel doing the monitoring should be instructed on appropriate steps to take when monitoring
indicates the need to take action. Data derived from monitoring should be evaluated by a designated person
with knowledge and authority to carry out corrective actions when indicated.
All records and documents associated with monitoring CCPs should be signed or initialled by the person
performing the monitoring and should also report the results and timing of the performed activity.
3.10 Establish corrective actions (Step 10/ Principle 5)
Specific written corrective actions should be developed for each CCP in the HACCP system in order to
effectively respond to deviations when they occur. When critical limits at CCPs are monitored continuously and
a deviation occurs, any product being produced at the time the deviation occurs is potentially unsafe. When a
deviation in meeting a critical limit occurs and monitoring was not continuous, then the FBO should determine
what product may have been impacted by the deviation.
The corrective actions taken when a deviation occurs should ensure that the CCP has been brought under
control and food that is potentially unsafe is handled appropriately and does not reach consumers. Actions
taken should include segregating the affected product and analysing its safety to ensure proper disposition.
External experts may be needed to conduct evaluations regarding the safe use of products when a deviation
occurs. It may be determined that the product could be reprocessed (e.g. pasteurized) or the product could be
diverted to another use. In other situations, the product may need to be destroyed (e.g. contamination with
Staphylococcus enterotoxin). A root cause analysis should be conducted where possible to identify and correct
the source of the deviation in order to minimize the potential for the deviation to reoccur. A root cause analysis
could identify a reason for the deviation that limits or expands the amount of product impacted by a deviation.
Details of the corrective actions, including the cause of the deviation and product disposition procedures,
should be documented in the HACCP records. Periodic review of corrective actions should be undertaken to
identify trends and to ensure corrective actions are effective.
3.11 Validation of the HACCP Plan and Verification Procedures (Step 11/ Principle 6)
3.11.1 Validation of the HACCP Plan
Before the HACCP plan can be implemented, its validation is needed; this consists of making sure that the
following elements together are capable of ensuring control of the significant hazards relevant to the food
business: identifying the hazards, critical control points, critical limits, control measures, frequency and type of
monitoring of CCPs, corrective actions, frequency and type of verification and the type of information to be
recorded.
Validation of control measures and their critical limits is performed during the development of the HACCP plan.
Validation could include a review of scientific literature, using mathematical models, conducting validation
studies, and/or using guidance developed by authoritative sources 10.

10 Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008).
 CXC 1-1969 29

Where HACCP guidance developed by external experts, instead of the HACCP team, has been used to
establish the critical limits, care should be taken to ensure that these limits fully apply to the specific operation,
product or groups of products under consideration.
During the initial implementation of the HACCP system and after verification procedures have been established,
evidence should be obtained in operation to demonstrate that control can be achieved consistently under
production conditions.
Any changes having a potential impact on food safety should require a review of the HACCP system, and
when necessary a revalidation of the HACCP plan.
3.11.2 Verification Procedures
After the HACCP system has been implemented, procedures should be established to confirm that the HACCP
system is working effectively. These include procedures to verify that the HACCP plan is being followed and
controlling hazards on an ongoing basis, as well as procedures that show the control measures are effectively
controlling the hazards as intended. Verification also includes reviewing the adequacy of the HACCP system
periodically and, as appropriate, when changes occur.
Verification activities should be performed on an ongoing basis to ensure the HACCP system functions as
intended and continues to operate effectively. Verification, which includes observations, auditing (internal and
external), calibration, sampling and testing, and records review, can be used to determine if the HACCP system
is working correctly and as planned. Examples of verification activities include:
 reviewing monitoring records to confirm that CCPs are kept under control;
 reviewing corrective action records, including specific deviations, product disposition and any analysis
to determine the root cause of the deviation;
 calibrating or checking the accuracy of instruments used for monitoring and/or verification;
 observing that control measures are being conducted in accordance with the HACCP plan;
 sampling and testing, e.g. for microorganisms11 (pathogens or their indicators), chemical hazards such
as mycotoxins, or physical hazards such as metal fragments, to verify product safety;
 sampling and testing the environment for microbial contaminants and their indicators, such as Listeria;
and
 reviewing the HACCP system, including the hazard analysis and the HACCP plan (e.g. internal and/or
third-party audits).
Verification should be carried out by someone other than the person who is responsible for performing the
monitoring and corrective actions. Where certain verification activities cannot be performed in house,
verification should be performed on behalf of the business by external experts or qualified third parties.
The frequency of verification activities should be sufficient to confirm that the HACCP system is working
effectively. Verification of the implementation of control measures should be conducted with sufficient
frequency to determine that the HACCP plan is being implemented properly.
Verification should include a comprehensive review (e.g. reanalysis or an audit) of the HACCP system
periodically, as appropriate, or when changes occur, to confirm the efficacy of all elements of the HACCP
system. This review of the HACCP system should confirm that the appropriate significant hazards have been
identified, that control measures and critical limits are adequate to control the hazards, that monitoring, and
verification activities are occurring in accordance with the plan and are capable of identifying deviations, and
that corrective actions are appropriate for deviations that have occurred. This review can be carried out by
individuals within a food business or by external experts. The review should include confirmation that various
verification activities have been executed as intended.
3.12 Establish Documentation and Record Keeping (Step 12/ Principle 7)
Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures
should be documented. Documentation and record keeping should be appropriate to the nature and size of
the operation and sufficient to assist the business to verify that the HACCP controls are in place and being
maintained. Expertly developed HACCP guidance materials (e.g. sector-specific HACCP guides) may be
utilized as part of the documentation, provided that those materials reflect the specific food operations of the
business.

11Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Food (CXG 21-
1997).
 CXC 1-1969 30

Examples of documentation include:

 HACCP team composition;
 hazard analysis and the scientific support for the hazards included or excluded from the plan;
 CCP determination;
 critical limit determination and the scientific support for the limits set;
 validation of control measures; and
 modifications made to the HACCP plan.
Examples of records include:
 CCP monitoring activities;
 deviations and associated corrective actions; and
 verification procedures performed.
A simple record-keeping system can be effective and easily communicated to personnel. It may be integrated
into existing operations and may use existing paperwork, such as delivery invoices, and checklists to record,
for example, product temperatures. Where appropriate, records can also be maintained electronically.
3.13 Training
Training of personnel in food businesses, government and academia in HACCP principles and applications is
an essential element for the effective implementation of HACCP. As an aid in developing specific training to
support a HACCP plan, working instructions and procedures should be developed which define the tasks of
the operating personnel in charge of each Critical Control Point. Training programmes should be designed to
address the concepts at a level appropriate for the knowledge and skill level of the personnel being trained.
Training programmes should be reviewed periodically and updated where necessary. Re-training may be
needed as part of corrective actions for some deviations.
Cooperation between food business operations, trade groups, consumer organisations, and competent
authorities is vitally important. Opportunities should be provided for the joint training of food business operators
and competent authorities to encourage and maintain a continuous dialogue and create a climate of
understanding in the practical application of HACCP.
CXC 1-1969 31

Annex 1 - Comparison of control measures with examples.

Control measures applied as GHPs Control measures applied at CCPs
General conditions and activities for maintaining Specific to production process steps and a product or group of products and
hygiene, including creating the environment (inside necessary to prevent eliminate or reduce to acceptable level a hazard
and outside the food business) so as to ensure determined as significant by the hazard analysis.
production of safe and suitable food.
Generally, not specific to any hazard but results in
Scope reduction of likelihood of hazards occurring.
Occasionally a GHP activity may target a specific
hazard and this may be a GHP that requires greater
attention (e.g. cleaning and disinfection of food
contact surfaces for control of Listeria
monocytogenes in a ready-to-eat food processing
environment).
After consideration of the conditions and activities After a hazard analysis has been completed, for each hazard identified as
When identified? necessary to support the production of safe and significant, control measures are established at steps (CCPs) where a deviation
suitable food. would result in the production of a potentially unsafe food.
Where necessary, and generally not carried out by Validation should be carried out (Guidelines for the Validation of Food Safety
FBOs themselves (Guidelines for the Validation of Control Measures CXG 69-2008).
Food Safety Control Measures CXG 69-2008).
Validation data provided by competent authorities,
published scientific literature, information provided
by manufacturers of equipment/ food processing
Validation of the technology etc. is adequate e.g. cleaning
control measures compounds/products/equipment should be validated
by the manufacturer and it is generally sufficient for
the FBO to use cleaning
compounds/products/equipment according to
manufacturers’ instructions. The FBO should be
able to demonstrate it can follow manufacturers’
instructions.
CXC 1-1969 32

GHPs may be observable (e.g. visual checks, Critical limits at CCPs which separate acceptability from unacceptability of the
appearance) or measurable (e.g. ATP tests of food:
equipment cleaning, concentration of disinfectant),
Criteria and deviations may require an evaluation of the  measurable (e.g. time, temperature, pH, aw), or
impact on safety of the product (e.g. whether the  observable (e.g. visual checks of conveyor belt speed or pump settings, ice
cleaning of complex equipment such as meat slicers covering product).
is adequate).
When appropriate and necessary, to ensure Necessary to ensure critical limit is met:
procedures and practices are applied properly.
 Continuously during production or
Monitoring
Frequency dependent on the impact on the
product’s safety and suitability.  if not continuous, at appropriate frequency that ensures to the extent possible
the critical limit has been met.
 For procedures and practices: Necessary  For products: Necessary pre-determined actions.
 For products: Usually not necessary. Corrective  For procedures and practices: Necessary corrective actions to restore control
action should be considered on a case- by-case and prevent reoccurrence.
Corrective actions basis, as failure to apply some GHPs, such as
when deviation has failure to clean between products with different  Specific written corrective actions should be developed for each CCP in the
occurred allergen profiles, not rinsing after cleaning and/or HACCP plan in order to effectively respond to deviations when they occur.
disinfecting (where needed) or post maintenance  The corrective actions should ensure that the CCP has been brought under
equipment checks indicating missing machinery control and food that is potentially unsafe is handled appropriately and does
parts, may result in action on product. not reach consumers.
When appropriate and necessary, usually scheduled Necessary: Scheduled verification of implementation of control measures, e.g.
Verification (e.g. visual observation that equipment is clean through record review, sampling and testing, calibration of measuring equipment,
before use). internal audit.
Record keeping When appropriate and necessary, to allow the FBO Necessary to allow the FBO to demonstrate ongoing control of significant
(e.g. monitoring to assess whether GHPs are operating as intended. hazards.
records)
Documentation When appropriate and necessary to ensure GHPs Necessary to ensure the HACCP system is properly implemented.
(e.g. documented are properly implemented.
procedures)
CXC 1-1969 33

Diagram 1 – Logic Sequence for Application of HACCP

1. Assemble HACCP TEAM

2. Describe Product

3. Identify Intended Use

4. Construct Flow Diagram

5. On-site Confirmation of Flow Diagram

List all Potential Hazards

6. Conduct a Hazard Analysis to identify the significant hazard(s) See Diagram 2
Consider Control Measures

Determine CCPs
7.

8.
Establish validated Critical Limits for each CCP

9. Establish a Monitoring System for each CCP

10. Establish Corrective Actions

11. Validate the HACCP plan and establish Verification Procedures

12. Establish Documentation and Record Keeping

CXC 1-1969 34

Diagram 2 – Example of Hazard Analysis Worksheet

(1) (2) (3) (4) (5)
Does this Justify your decision for What measure(s) can be
Step* Identify potential potential column 3 applied to prevent or eliminate
hazards hazard the hazard or reduce it to an
introduced, need to be acceptable level?
controlled or addressed
enhanced at this in the
step HACCP
B = biological plan?

C = chemical
P = physical Yes No
B
C
P
B
C
P
B
C
P
*A hazard analysis should be conducted on each ingredient used in the food; this is often done at a “receiving”
step for the ingredient. Another approach is to do a separate hazard analysis on ingredients and one on the
processing steps.
CXC 1-1969 35

Diagram 3 – Example of a HACCP Worksheet

Critical
Control Monitoring
Points Significant
When Corrective Verification
(CCPs) Hazard(s) Critical Limits What How (Frequency) Who Actions Activities Records
GOOD FOOD LABORATORY PRACTICES (GFLPs)

GOOD FOOD LABORATORY

PRACTICES

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE
GOVERNMENT OF INDIA
NEW DELHI
2016

1
GOOD FOOD LABORATORY PRACTICES (GFLPs)

GOOD FOOD LABORATORY PRACTICES (GFLPs)

TABLE OF CONTENTS

S.NO. TITLE PAGE NO.

1. Describe the scope of testing normally applicable for a
3
food laboratory
2. Structure of Food Lab 4
3. Infrastructure and accommodation and related Requirement 7
4. Environment Conditions, Safety and related Requirements 12
5. Personnel related requirements 15
6. Test methods 17
7. Equipment 18
8. CRM’s and reference cultures 21
9. Calibration and performance assessment related 24
requirements.
10. Purchase of consumables/equipment related 26
11. Sampling and sample handling 27
12. Quality assurance measures - Guidance on Internal Quality 33
Control measures as well as external QC measures for types
of Parameters required to be tested by the food lab –
General chemical, residue and microbiological.
13. Record keeping 37
14. Reporting 38

2
GOOD FOOD LABORATORY PRACTICES (GFLPs)

1.0 SCOPE:

1.1 These Guidelines specify the general requirements for the competence to carry out
systematic sampling of food samples, conduct chemical, microbiological tests and
testing of packaging materials to ascertain the quality of food. It covers the tests
performed using standard methods, non-standard methods, and laboratory-developed
methods.

1.2 These Guidelines are applicable to all organizations performing tests to ascertain
the quality of food material including packaging material. These include, for example,
first-, second- and third-party laboratories, and laboratories where testing forms part of
inspection and product certification.

These Guidelines are applicable to all laboratories regardless of the number of

personnel or the extent of the scope of testing and/or calibration activities. When a
laboratory does not undertake one or more of the activities covered by this Standard,
such as sampling and the design/development of new methods, the requirements of
those clauses do not apply.

1.3 The notes given provide clarification/guidance of the text and examples. They do
not contain requirements and do not form an integral part of these Guidelines.

1.4 These Guidelines are for use by laboratories in developing their management
system for quality, administrative and technical operations. Laboratory customers,
regulatory authorities and accreditation bodies may also use it in confirming or
recognizing the competence of laboratories. This International Standard is not intended
to be used as the basis for certification of laboratories.

NOTE 1 The term 'management system' in these Guidelines means the quality,
administrative and technical systems that govern the operations of a laboratory.

NOTE 2 Certification of a management system is sometimes also called registration.

1.5 Compliance with regulatory, calibration of equipment/glassware and safety

requirements on the operation of laboratories is not covered by these Guidelines. These
Guidelines are over and above ISO/IEC 17025:2005 framed specially for those testing
laboratories engaged in sampling, conducting chemical and/ or microbiology tests and
testing of packaging materials to ascertain the quality of food. Laboratories seeking
accreditation as per ISO/IEC 17025:2005 should comply with the requirements of
ISO/IEC 17025:2005.

3
GOOD FOOD LABORATORY PRACTICES (GFLPs)

2.0 STRUCTURE OF FOOD LAB:

2.1 Personnel:

Personnel need to clearly understand the nature of the foods they are testing and
reasons for testing when undertaking contract review and method selection.

2.2 The Management Structure:

An up-to-date chart showing the organisational structure and lines of responsibility of

the laboratory is an important feature of the quality assurance programme and should
appear in the Quality Assurance Manual. When the laboratory is part of a larger
organisation it may also be desirable to have a chart showing the management and
operational relationships which control the input of work requested and the output of
results from the laboratory, the overall picture of the laboratory and the resources
available for it. The general structure of staff is shown in Figure 2.1.

The office of Head of Laboratory (other titles such as "Chief" or "Director" are often
used) may include a Deputy if the laboratory staff is sufficiently large. Usually, however,
the duties of the Head, in his or her absence, are assumed by a senior supervisor of the
analytical staff. The analytical and support staffs are discussed below in Sections 2.5
and 2.6, respectively. The administrative staffs includes all administrative assistance
such as a secretary, typing and filing clerks, a management assistant and a librarian (if
the laboratory library is of a size to need one). Basically the administrative staffs are
those persons generally involved in "office" or "paperwork" functions. These staffs are
very important to the smooth operation of a laboratory. It is false economy to understaff
the administrative group because their work often must then be done in part by the
analytical or support staff.

Figure 2.1 The staffing structure of a typical food testing laboratory is as follows:
Head of Laboratory
Officer –in- Officer –in- charge Officer –in- Officer –in-
Charge (Microbiological charge charge
(Chemistry Section) (Biotech. (Administrative
Section) Section) Section)
Team Leaders Team Leaders Team Leaders Secretarial Staff
Technical Technical Technical Supporting Staff
Staff/Analyst Staff/Analyst Staff/Analyst
Supporting Staff Supporting Staff Supporting Staff

4
GOOD FOOD LABORATORY PRACTICES (GFLPs)

2.2 Head of the Laboratory:

Although the duties of the head of the laboratory are many, some may be delegated and
others undertaken by other parts of the food control administration. The laboratory
Head may have to give evidence in court or write documents used in court, in which
case he must have a thorough understanding of food and related law and court
procedure. There will also be involvement in committee work and relations with other
organizations. The laboratory Head is usually the spokesman for the laboratory in many
instances.

Note: In case of FSSAI labs, the Head must prepare work plans with the food safety
officers (FSO) and overall food control authorities. Sampling plans agreed with the FSO
should aim at areas of concern and major abuses.

2.3 Supervisors:

The supervisor is the on-site manager of the laboratory. Having supervisors assigned to
specific units or areas of work permits the Head to more effectively plan for execution
the total workload of the laboratory.

Supervisors can be expected to do analytical work in addition to their supervisory

duties. However, if their group exceeds five professional analysts, it is best not to
require additional analytical work except for occasional problem solving and trouble-
shooting. A reasonable maximum number of analysts for one person to supervise is 10
to 12. This can be more if nonprofessional support staff is added.

A supervisor's duties can include the following:

1. Assisting the Head in overall laboratory work planning and planning the work of
the group supervised.
2. Receiving and assigning samples for analysis, within the group.
3. Answering questions and assisting in solving analytical problems posed by
individual analysts.
4. Reviewing the reports of completed work and making appropriate
recommendations.
5. Ensuring that the group has the necessary supplies and equipment to do the work.
6. Ensuring that proper laboratory safety and housekeeping practices are followed by
the group.
7. Recommending to the Head new instruments or equipment needed, and training
needs of individual analysts.
8. Recommending appropriate disciplinary action when needed to enforce laboratory
rules or regulations.
9. Supposed to manage the entire laboratory in the absence of the Head.

5
GOOD FOOD LABORATORY PRACTICES (GFLPs)

Supervisors should train one or more analysts in their group to serve as backups, to
supervise the group in the supervisor's absence. The back-ups should be given some
formal classroom training in supervision in addition to on-the job experience.

2.4 Team Leaders:

Another important, and often overlooked, position is Team Leader. A team leader is a
senior analyst who has been assigned a small group, usually not more than 4, to do a
specific task or type of analysis. The leader has no supervisory functions as such, but is
the coordinator of the group's activities and is the contact point for the supervisor.

Team leaders are most useful when a large number of a repetitive type of analysis is to
be done in a specified period of time. This could be a specific analytical survey or an
emergency public health problem requiring screening analysis. The leader usually
works along with the group in addition to the coordinative function. Such experience is
often useful to determine if the assigned leader has potential as a future supervisor.

2.5 Analytical Staff:

The basic job of the analytical staff is to analyze the samples received and to issue a
report. They may also be required to appear in court as fact or expert witnesses to give
evidence in relation to a report. They may also be called onto offer advice to industry
and trade, to assist in improvement of food quality, or advice on conformity with
standards or other legal requirements. This can involve the laboratory staff in factory
visits and even requests to carry out experimental work. Whether or not the laboratory
undertakes such work will be a matter of organizational policy. The decision will
depend on a number of factors, including the availability of alternative facilities, the
nature of individual ownership, etc. The integrity of the analyst is paramount, and
superiors must be informed of any conflict of interest that arises. As in the case of food
inspectors, it is proper for the analysts to have no vested interest in regulated
industries. This requirement is mandatory in many countries.

2.6 Support Staff

The support staffs of a laboratory is those persons working in and for the laboratory
who are not conducting analyses or are not involved in administrative duties. Some
examples of duties include:

1. Glassware washing.
2. Cleaning and housekeeping maintenance.
3. Disposal of sample reserves (when no longer required).
4. Pest control.

6
GOOD FOOD LABORATORY PRACTICES (GFLPs)

5. Heavy lifting and moving.

Support staffs typically have little or no educational qualifications beyond the ability to
read and write. However, they must be willing and able to learn not only their duties,
but also laboratory safety procedures. It is most important that sufficient persons are
hired as support. The work they do must be done by someone and this is usually an
analyst or technician when there is insufficient support staff. There is no fixed module
for numbers of support workers, but 15-20% of the number of analytical staff is often
sufficient.

3.0 INFRASTRUCTURE AND ACCOMMODATION AND RELATED REQUIREMENTS:

3.1 General Principles:

Facilities must allow the laboratory's work to proceed both effectively and safely.

Laboratory design should reflect the general features of the work programme
anticipated in the long-term (10-20 years) rather than the specific pattern of current
work.

3.2 Design of the Laboratory:

Even though the final design of the laboratory is made by architects and engineers, the
analytical staff should be involved in some of the decisions that will ultimately affect
their working environment and conditions. The food control laboratory have several
functions such as chemical analysis of foods for proximate composition, trace metals,
additives, GM testing, nutrients and toxicants, some basic food microbiology analysis
and product organoleptic evaluation .

3.3 General Considerations:

Laboratory layout should be devised with efficiency in mind. For example, the distances
staff have to walk for the different steps of the analytical processes they undertake
should be as short as possible, though bearing in mind that some procedures may have
to be segregated from others for analytical and/or safety reasons.

There is often a 5 year period from the decision in principle to build a new laboratory to
when it is accepted and operational. Also there will usually be an expectation that it will
not require major alteration for a further 10 years. Given that the work load may change
in this time span there are real disadvantages in designing a laboratory just to reflect
the detail of the currently anticipated work load. Even within a given work volume,

7
GOOD FOOD LABORATORY PRACTICES (GFLPs)

events may demand that the relative emphasis given to the different types of analyses
may change. Additionally, advances in instrumentation and analytical methodology may
alter the space and environmental requirements for a particular analysis. There is an
argument for designing a laboratory in terms of "generic" activities and "specialised"
activities.

Generic activities can be categorized as "wet chemistry" which will require extensive
provision of fixed benches with water, power, sinks, fume cupboards, reagent shelves,
glassware cleaning and storage, as compared to "instrument rooms" where less
extensive servicing (though with additional piped gas supplies and perhaps stabilised
power supplies) and flexible arrangements of movable tables/benches may be
adequate.

Specialised rooms may be required for "clean air" work (e.g. on some environmental
contaminants) or for work with substances which need to be handled with special care
either for safety or for cross-contamination reasons, e.g. radioactive materials and some
particularly toxic substances or for storage and dispensing of standards of pure
compounds which are being analysed at trace levels elsewhere in the laboratory. A
specialised room for large-scale and/or dusty sample preparation activities, e.g.
grinding, blending, mixing, stirring will be invaluable, particularly if work is envisaged
on heterogeneous analytes (e.g. aflatoxins in nuts or figs where primary samples of 30
kg are sometimes needed). With this approach the important design parameters are
those concerned with correctly identifying the needs for specialised activities and with
estimating the relative needs for the generic activities of "wet chemistry", "instrument
room" and - for that matter - "food microbiology" if, as is often the case, that is to be
carried out in the same premises.

Offices are needed for management and for clerical staff. There must be toilet and
washing facilities for all staff. Eating, drinking, and smoking are always discouraged, and
should be prohibited, in the laboratory proper. It is the responsibility of management to
provide an appropriate alternative area for these activities. A separate staff room,
however small, deserves consideration since it not only provides a greater degree of
safety to laboratory personnel but also helps to ensure sample integrity. To provide for
a prompt exit in the event of fire or other emergency, at least two entrances/exits must
be provided for each laboratory whenever possible.

3.4 The Chemical Laboratory:

From a quality assurance standpoint, the design features which are important are those
which can lead to erroneous results or to "lost" work, leading to missed deadlines and
cost overruns. Erroneous results can arise from test materials becoming contaminated
(e.g. by dust) or by cross-contamination from another sample or from a standard. Whilst
good working practices will usually control most situations satisfactorily, a design

8
GOOD FOOD LABORATORY PRACTICES (GFLPs)

which provides complete segregation of trace analyses from highly concentrated

formulations and from pure substances used in preparing analytical standards is
virtually essential: the segregation must apply to all facilities for washing/cleaning
equipment, washing and storage of glassware, use of protective clothing and even
transfer of notebooks and records.

Design features which avoid dust, whether from environmental sources or from other
samples are highly desirable from the quality assurance standpoint. Dust contamination
of test materials is essentially sporadic and uneven; as such it is likely it will often be
missed by the normal quality control checks. Design should aim for dust avoidance by
using glass-fronted reagent shelves, keeping work-tops clear of unnecessary "static"
items, regular cleaning of work surfaces with absorbent cloths, floor and furniture
designed so that they can be cleaned with vacuum cleaners with suitable exhaust filters
or absorbent mops. Designs which involve cleaning by the traditional "duster and
brush" approach which simply spread contamination more widely should be avoided.
Ventilation intakes and fume cupboard exhausts must be sited carefully so as to avoid
re-circulation of laboratory air and the associated risk of contamination of test materials
and hazard to laboratory staff.

3.4.1 Equipment and Instruments:

The complexity of equipping a laboratory and the consequent delay in production of

useful results should not be underestimated. In the early stages, the requirements for
equipment may seem large and complex but once the laboratory is established, the
running costs are relatively low. It is sometimes not appreciated by the non-technical
administrator that an analysis may require 10 or 20 individual items and that if even
one is not available the analysis cannot be carried out. On the other hand, many items
are common to different analyses so that, once the many hundreds of items required in
a food control laboratory have been provided, there comes a point at which productivity
can rise sharply and investment decrease. The logistical problems of maintenance,
repair and replacement of equipment are also considerable. Adequate provision must
be made for obtaining spares and replacement parts and for their storage. It is false
economy if staff are being paid but cannot do an important part of their work due to a
lack of relatively inexpensive equipment. Some of the instruments and equipment
needed for chemical analysis by a modern food control laboratory are: (for purposes of
this listing, 'instruments' are measuring devices and 'equipment' are processing devices.
Apparatus made primarily of glass are not included).

Some of the instruments and equipment needed for chemical analysis by a modern food
control laboratory are: (for purposes of this listing, 'instruments' are measuring devices
and 'equipment' are processing devices. Apparatus made primarily of glass are not
included).repeated.

9
GOOD FOOD LABORATORY PRACTICES (GFLPs)

Instruments:

1. Analytical Balance
2. pH meter
3. Spectrophotometer, UV-visible, double-beam
4. Spectrophotometer, atomic absorption
5. High Performance Liquid Chromatograph (with UV and differential refractive
index detectors)
6. Gas Chromatograph (with flame ionization and electron capture detectors)

Equipment:

1. Blender
2. Grinder
3. Pulverizing hammer mill
4. Air oven, forced draft
5. Vacuum oven, with pump
6. Muffle furnace
7. Centrifuge
8. Refrigerator
9. Freezer
10. Heaters and hot plates
11. Steam and water baths
12. Water distillation still or deionizer

All of the above equipments and instruments are moveable, although the larger or more
sensitive units are generally not moved, once placed. The major items of fixed
equipment constructed in place are the fume hoods. The extensive use of solvents,
ashing and noxious chemicals in food analysis, requires more fume hoods than other
types of laboratory work. In fact, to experienced food analysts, there never seem to be
enough hoods, even in a well-equipped laboratory. Fume hoods may be purchased pre-
fabricated with outlets for services. The material of construction is most important,
especially if the hood has to withstand acid fumes in general and perchloric acid in
particular. The supplier must be given full details of the use to which the fume hood will
be put. Hoods can be constructed out of local materials such as wood, preferably hard
woods, coated with epoxy resins. Such should never be used for acid digestions, but only
for solvent extraction work.

3.4.3 Utilities:

Electricity must either be a stable supply, or the voltage must be stabilized by either one
large stabilizer for the whole laboratory, or by a unit for each of the instruments

10
GOOD FOOD LABORATORY PRACTICES (GFLPs)

requiring it. The lab should have sufficient number of electrical sockets. There must be
several cold water taps per bench to allow for rinsing, condensers, etc., but hot water
can be restricted to those sinks where apparatus is washed. In a larger laboratory a
distribution system for distilled or deionized water would be advantageous. Fume
hoods should have adequate provision for water taps, compressed air valves, electrical
sockets etc.

Special methods, such as trace analysis, usually require distillation from glass apparatus
of water initially partially purified by distillation or deionization. The initial purification
produces water very low in salts, but if the original supply contains organic matter this
may not be removed, and traces of resin material may be present. A steady supply of
compressed air is required for an atomic absorption spectrophotometer (AAS) and is
very useful to have available at the bench. A compressor is suitable for use with the
instrument but if used for other purposes at the same time it must be capable of
supplying those needs without affecting the AAS supply. Apart from the inaccuracy that
will result from a change in the flame characteristics, sudden failure of the air may
result in a flashback, which is expensive if the mixing chamber is destroyed, and could
be dangerous. However, it must be emphasized that manufacturers design this part of
the instrument to be as safe as possible under flashback conditions. Therefore, in many
ways it is probably better to have a separate air supply to the AAS. This instrument also
has to be provided with a ventilation hood to remove gases formed during operation,
particularly if nitrous oxide is used as the fumes are very toxic.

Utility services require a large space but need to be concealed for aesthetic reasons, yet
require an easy access for repair purposes. To satisfy these conflicting demands, the
main runs may be in voids above false ceilings and in floor ducts. Secondary services are
then run to outlet points on benches taken from floor level along the wall behind
benches in voids especially incorporated in the design of the bench fittings. Frequent
access points are provided for maintenance purposes.

Drain pipes should be of high density polythene or copolymer polypropylene with

screwed joints. These show good resistance to most organic and inorganic chemicals.
The drainage lines may be embedded in the flooring. As it is not acceptable to discharge
laboratory wastes directly into the sewerage system, all waste from laboratory sinks
and other waste fittings should be led first into dilution pots (about 5 litre capacity)
before being released into the main sewers. Buildings can be designed to include a large
dilution tank where all laboratory sink waste is directed before entering the sewerage
system.

11
GOOD FOOD LABORATORY PRACTICES (GFLPs)

4. ENVIRONMENT CONDITIONS, SAFETY AND RELATED REQUIREMENTS:

4.1 Environmental Control:

Adequate control of temperature, humidity and dust is important to staff comfort,

instrumental performance and safe working (e.g. with flammable solvents). If they are
to perform properly optical instruments often require stable temperature conditions.
Electronic equipment may have prescribed operating ranges for environmental
temperature and humidity. Computers may need to be protected from strong magnetic
fields from other equipment; any staff or visitors with heart pace-makers must avoid
such fields. Cooling water, either from mains supplies or localised refrigeration may be
necessary for the proper functioning of some equipment. Test materials, reagents,
standards may need to be stored under controlled conditions. Some substances are
affected by sunlight or fluorescent lights and must be protected from it. Delicate
balances and optical instruments may need to be protected from vibration (e.g. from
blenders, shakers and centrifuges) or may even need stabilised supports. All these
needs have to be identified and documented so that proper procedures for monitoring
them and taking necessary action can be included in the quality assurance system.

Records will be needed which show that: samples are received, stored, handled and
analysed under environmental conditions that will not adversely affect analyses;
temperature, humidity and light controls are adequate in sensitive areas to protect
samples, extracts from them, personnel and equipment; the results of environmental
sampling in laboratory areas are recorded; these should include records of air-flow
rates across fume cupboard apertures.

4.2 Housekeeping Control:

As with any other aspect of the laboratory's activities, the responsibility for
housekeeping activities must be clearly defined. Cleaning staff and laboratory staff must
each have clear instructions as to their respective duties in relation to:

1. cleaning of floors, vertical surfaces (e.g. cupboards, walls, windows and

doors),
2. horizontal surfaces (e.g. work surfaces, shelves), equipment, interiors of
refrigerators, freezers, fume cupboards, controlled environment stores
3. control of the contents of refrigerators, freezers, fume cupboards, controlled
environment stores
4. checking the performance of air-conditioning and dust extraction equipment
and fume-cupboards
5. pest control

12
GOOD FOOD LABORATORY PRACTICES (GFLPs)

The quality assurance programme will include work schedules, records of observations
and of action required/taken covering housekeeping activities of this nature.

4.3 Safety Features:

The building and laboratory design should include a number of safety features
including:

1. The fire areas of corridors should be formed of concrete blocks.

2. Services should include a shower sprinkler system near each doorway so that a
worker can take an immediate shower, clothes and all, in the case of accidental
general contact with corrosive or poisonous liquids or fire.
3. There should be built-in eye wash fountains or at least portable eyewash stations
(obtainable from most chemical supply firms).
4. The traffic flow, the egress pattern and the proportions of the laboratory are all
safety considerations. It must always be possible to leave the laboratory safely
irrespective of the initial site of a fire. Serious thought must be given to the number
and location of fire extinguishers and stand pipe systems, and to the availability of
sprinkler systems.
5. Laboratories should be well-lit so that the operator does not have to peer too
closely over potentially hazardous material in order to see what he is doing. There
should be ample working space and bench tops and other surfaces should be kept
clear of all material except that in current use.
6. Benches are best without shelves, only services, these being operated from the
front so that the operator does not have to stretch across the bench. It is still
common to see reagents on shelving at the back of benches (or above the centre of
double-width benches) but it is probably safer if such reagents can be kept on side
- shelve or in trays which are brought to the bench as required.
7. Flooring needs to be of a non – slip material, resistant to acids and solvents, but not
so hard as to be tiring to stand on for a few hours at a time. No material is entirely
satisfactory. Well-laid linoleum and a filled epoxy resin on top of concrete are
among the best available. It is advisable not to polish laboratory floors.
8. Pollutants generated within the laboratory must be removed safely, quickly and
efficiently. In particular, toxic or noxious gases must be removed expeditiously
through a duct system that does not exhaust near the building air conditioning
intake.
9. The building must be planned for security. Restriction of access is of considerable
importance because of the extremely valuable and sensitive equipment used in the
laboratory work as well as to protect the integrity of official samples.
10. It is very advisable to have an efficient fire and smoke detection system with
appropriate alarms. Common fire detection equipment is usually either rate-of-
temperature-rise or fixed-temperature detector using a substance of known

13
GOOD FOOD LABORATORY PRACTICES (GFLPs)

melting point. There are advantages (and disadvantages) to each type of detector
and the laboratory Head should select the one he feels best fits his laboratory.

Designing a laboratory to afford protection against every kind of hazard should be

aimed at, but, the level of safety for the most general applications and to provide
supplementary systems in areas of higher hazard has to be achieved.

A safe solvent storage area is ideally separate from the laboratory building in a stand-
alone structure. It can be a small building of one room and some possible design
features are: (reasons are given in parenthesis)

1. Construction of cement blocks or bricks. (Only non-flammable materials surround

the solvents.)
2. For a stand-alone building, double walls with insulation between. The exterior wall
can be material other than block or brick. (Provides insulation from the sun and
makes air conditioning more effective.)
3. An epoxy film to cover the entire floor plus 10 cm up the base of the walls. (Any
solvent spillage will pool and evaporate, rather than soak through the floors or
walls.)
4. A copper pipe (about 25 mm) inside the room, which goes through the floor and is
embedded about 2 m in earth. (A ground pipe to bleed off any static electricity
charges - which often build up when solvents are poured).All metal objects in the
room are to be attached to the pipe using heavy guage single strand copper wire.
Also, attach a short wire with an alligator clip. (This grounds all metal. The clip is
used to ground any metal cans used for solvent transfer.)
5. Storage shelves of metal and connected by wire to each other and the grounding
pipe.
6. Air conditioning is external, with the entrance duct at the top of one corner of the
room and the exit duct at the base of the opposite corner.(The room must be cooled
as many solvents will boil at hot outside temperatures. The air entrance on top and
exit on the bottom diagonally across the room, will cool the room and will also serve
to sweep and remove any solvent fumes on the floor - solvent fumes are generally
heavier than air and will pool on the floor.)
7. The door is of metal and fire-rated for at least one hour, with a positive closure. It
must seal well when closed. The door sill is at least 10cm high. (Fire doors are metal
sheathed around cement. The closure, the sea land the high sill all act to prevent
escape of solvent, either floor spillage or fumes.)
8. Air conditioner exits duct with a fire baffle (to prevent flashback) and ducted to exit
in the outside air at building roof height. (Fumeshave a better chance of being
carried away by breezes and someone smoking nearby will not present a fire risk.)
9. An extinguisher system, which should be carbon dioxide or Freon type and not
water sprinklers.

14
GOOD FOOD LABORATORY PRACTICES (GFLPs)

5.0 PERSONNEL RELATED REQUIREMENTS:

1. The personnel should be technically competent to perform their duties as allotted

to them whether operating on specific equipments/ performing tests /evaluating
results/signing the reports.

2. Qualification for doing specific tasks shall be judged on the basis of their education,
training, specific experience and demonstrated skill.

3. Regular and refresher training should be organized to keep the personnel update
in their domain of activity.

4. Specific job description for each personnel should be defined with their role and
responsibility.

5. Personnel should wear proper uniform and protective clothing’s, etc as required
depending upon the test method.

6. While doing test no phone calls/ cell calls should be attended to avoid any type
hazards and carelessness while performing the test.

7. Normally blank determination along with the known-standards must be carried

out in duplicate/ replicate to check the accuracy of the results obtained and human
error etc.

8. All the analysis records must be documented either through hardcopy or through
soft copy to demonstrate that the tests are really been carried out.

9. Random checking of the result should be done inter-laboratory and intra-

laboratory to check the proficiency of the personnel.

10. In case of hazardous analysis, special precautions as provided in the methods

should be taken for self and surroundings.

11. While opening and closing the laboratory room, safety precaution should be taken
care of depending upon the nature of the laboratory, equipment and test method.
Special care should be taken for microbiological lab. Instructions in this regard
must be displayed in the lab.

12. In case of contractual appointment, technical competency of the personnel should

be judged and they should be put on job only after they are trained and their
competency in the respective field is established.

15
GOOD FOOD LABORATORY PRACTICES (GFLPs)

13. Alternative arrangement of personnel should exist in case one is not available but
not at the cost of their technical competency.

14. Personnel should be medically fit depending upon the test method he is deployed
to avoid any hazards.

15. Special precaution should be taken by the personnel during break time to ensure
that tests are carried out as per prescribed method and no relaxation is given in
the test method.

16. Calculation should be rechecked on random basis by the supervisor.

17. Daily wages should not be put to job.

18. The personnel at the time of working in the laboratory should be alert and
concentrate on their work only.

19. Supervisory officer should randomly watch the analysis activity and guide from
time to time to increase the competency of analyst.

20. Eating habits should be avoided in the laboratory.

21. First Aid box should be available in the lab. along with emergency Telephone no.
of hospital/doctors/contact person.

22. During odd times person should avoid working lonely.

23. Fuming chamber must be used for test requiring ash, protein determination,
evaporation of solvents etc.

24. While pouring down acids etc in the basin, water taps should be kept on slowly.

25. Electrical equipments should be handled with great care.

26. Poisonous and hazardous chemicals must be kept under safe custody.

27. Manual sucking from mouth of liquid should be done with bulb type pipette.

28. Competency of the personnel should be judged regularly by giving unknown

samples.

29. No external or internal pressure should be put on analyst.

16
GOOD FOOD LABORATORY PRACTICES (GFLPs)

30. Output should not be linked with quantum of work. More emphasis should be on
quality output or results.

6.0 TEST METHODS:

1. The laboratory shall use only official methods depending on the requirement of
the test, its sensitivity and nature of the commodity which is being tested and
quality/safety factors to be determined.

2. In case of non-official method, validation of the methods as per set norms is a

must and their range of detection/quantification, L.O.D./L.O.Q. limitations etc.
must be established.

3. Selection of method is very important depending upon the requirement of the

test and customer requirement.

4. Estimation of uncertainty of measurement should be available for each method

in context of the food commodity and test to be done.

5. External calibration of the equipment is a must annually or depending upon its

use. However in case of any equipment being used very frequently, internal
calibration facility should be available and done regularly with a record thereof.

6. Glass apparatus should be calibrated.

7. In case of standard chemicals required in testing, whose purity can alter the
result should be certified reference material with proper traceability.

8. In case of recovery and PPM level extraction from a food commodity, percentage
recovery must be established for each food and the contaminant/constituent
which have to be determined and the calculation should take care of such
recovery.

9. Sometimes official methods do not prescribe the interfering material in the test
method, limitations ,its sensitivity, range of detection and qualification,
capability of the equipments being used, due to change of the sophisticated
equipment as prescribed in the method for a particular model/ technology.
Hence it is necessary to establish the suitability of such methods for their
particular test and equipment, etc before giving the results. Obviously the
method needs to be validated internally for its particular use using particular
equipment.

17
GOOD FOOD LABORATORY PRACTICES (GFLPs)

10. Standard solution/CRM Solution should be stored at required temperature and

condition and its strength should be checked regularly and record thereof should
be maintained.

11. Calculation should be done and rounded off while reporting the results to the
required level of standard.

12. SOP as far as possible should be available for test method along with the
protocol.

13. Method should be available while performing any test to follow exactly the test
method prescribed. No short cuts should be followed and tests should not be
done on a memory basis alone.

14. Purity of the solvents, water being used and other chemicals should be checked
regularly and a record thereof should be maintained.

15. In case of any controversy or marginal results, only reference methods should be
used.

16. In case of micro biological analysis standard culture must be available to

establish the confirmation of the microbes. SWAB testing must be done for
inoculation room and media preparation room regularly to ensure that it is not
contaminated.

17. The results should be recorded commensurating with the calibration of the glass
apparatus etc e.g. in case of a burette, the result should be reported only to the
displayed capabilities of the burette.

18. Special precaution should be taken for pipetting and ejecting the solution from
the pipette. The solution should not be blown by air through mouth.

19. All the apparatuses specially glass should be contamination free and should be
cleaned and rinsed thoroughly before use. No chemicals should be used after its
expiry or otherwise if it looks like deteriorated or decomposed.

7.0 EQUIPMENTS:

1. All the equipments being used should be under permanent control of the
laboratory and should be capable of in context of the test method.

18
GOOD FOOD LABORATORY PRACTICES (GFLPs)

2. The equipment must be calibrated depending upon the requirements by an

outside accredited lab and/or internally as the case may be.

3. In case the sophisticated instruments are shifted from one place to another the
same should be re-calibrated.

4. Depending upon the uses, the equipments should be internally calibrated either
daily or at a periodically interval as the case may be.

5. Instruction manual, operation manual and other details of the equipments like
calibration, due date of calibration, safety precaution, etc must be available at the
side of the equipment.

6. Each equipment should be uniquely identifiable.

7. The equipment should be placed and test must be performed under a proper
environmental condition as prescribed. Normally the room should be dust-free,
air conditioned with controlled humidity. Special condition needs to be followed
in case of equipment being used in case of micro biological analysis like Air
handling unit, etc.

8. Each sophisticated equipment should have IQ, OQ and PQ Certificate from the
manufacturer.

9. LOD/LOQ/ Range of detection/ range of quantification must be established for

each equipment in context of the test method, nature of the food commodity,
constituent to be determined. The reason being that normally in official
methods, the model of the equipment being used along with its accessories
becomes old whereas due to technological advancement a model of the
equipments are upgraded along with accessories and software, hence the LOD,
LOQ, etc must be established and should be checked as claimed by the
manufacturer which may not commensurate with the limits given in the official
methods. SOP must be available for operation.

10. Equipments not working should be placed under a tag “ out of order”

11. Software being used in the equipment must be validated and a record thereof
should be available.

12. Maintenance plan of the equipment should be available and should be done
under annual maintenance contract.

19
GOOD FOOD LABORATORY PRACTICES (GFLPs)

13. Equipments should not be subjected to overloading or mishandling which could

give erroneous results.

14. In case the equipment send outside the laboratory for repair, etc. proper
procedure of packing and transportation as prescribed by the manufacturer
should be followed.

15. Intermediate checks of the equipments must be done through known and
certified standards regularly. The equipment should be handled by technically
competent and trained personnel only. Such personnel should be trained on
routine maintenance and minor repair of the equipments.

16. Proper procedure as prescribed by the manufacturer should be followed for

cleaning of the equipments and its accessories before and after use.

17. The SOP for safe handling, transportation, storage, use and plant maintenance of
the equipments must be available to ensure proper functioning and to prevent
deterioration /contamination.

18. Do and don’ts regarding important instruction should be available along with
side of the equipments and should be visible all the time.

19. Due care should be taken to ensure constant voltage supply of electricity as
required for the equipment to avoid fluctuation and thus variation in results.

20. After return of the equipment from repair, the same procedure should be
followed as that for new equipment to ensure that the results rendered by the
equipments are as per capability of the equipment. In such cases the
instruments needs to be recalibrated before put to use.

21. Equipments where gases are being used, the purity of the gas should be as per
requirement of the equipment/test method.

22. Gas cylinders should be put outside the laboratory room at a well secured and
approachable place.

23. Temperature and humidity of the room where the equipments are placed must
be recorded daily. In case of micro biological laboratory, special precaution
should be taken as per requirement of the test method for environmental
conditions especially in case of isolation and determination of pathogens.

24. In case of a mobile food testing laboratory a separate SOP should be available
and the equipments used in such laboratory should be technologically sturdy to

20
GOOD FOOD LABORATORY PRACTICES (GFLPs)

avoid variation in results. Calibration of such equipments needs to be done very

frequently preferable daily before being put to use.

25. Software being used in the equipment should be capable of achieving the
accuracy required and should be complied with the specification related to the
test method.

26. Software should be upgraded and validated from time to time.

27. Obsolete equipments giving erroneous results in context of the requirement of

the test method should not be put to use.

28. The equipment should be placed on a vibration free platform.

29. Daily cleaning of the equipment should be done by trained personnel as per SOP

30. Proper safety precautions should be taken for equipments running round the
clock in the absence of the personnel.

8.0 CERTIFIED REFERENCE MATERIALS / STANDARDS AND REFERENCE

CULTURES:

Testing, validation/calibration, standardization & reference materials are inter-related

due to dependent on each other. Without proper reference materials, it is not possible
to make up any idealized and reliable measurement system. As per the lab quality
assurance procedure reference materials are required for all types of testing and
validation/calibration. These are widely used for validation/calibration of an apparatus
and testing procedure, assessing the true value.

The reference materials are generally used for, to develop and validate accurate method
of analysis ensuring traceable measurement results at the working level, to calibrate
measurement system and to demonstrate the accuracy of results, assure the long term
adequacy and integrity of measurement quality assurance programme and monitor the
lab performance, use in inter laboratory comparison and proficiency testing
programme.

The laboratory shall ensure to maintain the reference standards, which are certified by
the competent body having traceability to a national/international system like NIST etc.
The certificate provided by the supplier/manufacturer shall be maintained in the
laboratory for records.

21
GOOD FOOD LABORATORY PRACTICES (GFLPs)

The reference standards having high purity, critical characteristics and require to store
in special condition and hence its, to be stored in appropriate special condition as per
the requirements. The substances are to be kept in sealed vial and shall be stored in dry
place, away from heat, sunlight & moisture.

The reference material of various parameters such as metals, pesticides, antibiotics,

volumetric standards etc. may be received from standard brand like Sigma, Aldrich,
Fluka, Riedel-de-Haen, Dr. Ehrenstrofer Gmbh, Merck, Supelco etc. in regular intervals
accompanying with certificates with proper label. The certificates shall include the
name of the standard, the purity, uncertainty at a stated level of confidence, expiry/
validity/ shelf life, QC release, chemical formula / structure, assay/potency level of
confidence / chromatogram, storage condition etc. The same shall be verified for the
label, certificate & condition during receiving of the standards.

The reference standard solutions are required for sample analysis, quantification and
QC checks. The laboratory shall be prepared the standard solution as needed like stock /
primary, intermediate & working solution and wherever applicable the purity shall be
considered during preparation. The standard solutions shall be kept in screw capped
glass vials, standard volumetric flasks/stoppered conical flask (transparent/amber
coloured) in air-conditioned room / refrigerate /deep freezer depending upon storage
condition & requirements.

The standards shall be prepared from bulk reference standard materials received from
the market as A grade material. The selection criteria for the bulk material intended to
accept as working standard in assay and purity of substances. For accepting the
material to be taken as working standard the molecule must be subjected to chemical
characterization. First the standard stock solution to be prepared from which different
working standard is made. The preparation of standards is generally carried out in
regular interval as per the requirement / laboratory protocol and the records of those
are to be maintained and labelled with concentration & date of preparation.

The preparation of working standard is generally carried out during analysis/

whenever necessary and records of these are to be maintained.

The intermediate checks of the standards shall be checked in regular interval to ensure
the performance, stability & integrity of the standards and records of those are
maintained with Quality Control Chart / Levey-Jennings Chart etc.

The shelf life / expiration date declared by the reference standards providing
organization is generally applied to unopened condition that have to store at
recommended temperature. Hence it is the responsibility of the laboratory to maintain
the critical characterization, performance, stability & integrity of the standards through

22
GOOD FOOD LABORATORY PRACTICES (GFLPs)

proper handling, storage etc & same shall be ensured by the intermediate checks in
regular interval / as per the laboratory protocol.

For some reference standards the shelf life / expiration date may not declared by the
reference standards providing organization, in those cases the following shelf life may
be considered when the standards are stored un opened at recommended temperature
1. Room temperature items, which are not temperature sensitive and usually
are stabled for five years from the date of receipt.
2. Refrigerated items usually are stabled for two years from the date of receipt.
3. Freezer items usually are stabled for one year from the date of receipt

However it is the primary responsibilities of the laboratory to ensure the performance,

stability & integrity of the standards through intermediate checks in regular interval /
as per the laboratory protocol.

Reagent solution/standard solutions shall be prepared in established manner, for

preparation of reagents the testing personnel refers to be relevant reference. After their
preparation, those are to be stored in appropriate storage condition i.e. protected from
light, tightly stoppered, refrigerated etc. Wherever, it is recommended reagents are to
be prepared freshly. All the reagents/solutions bottles shall be properly labelled with
name, date of preparation, concentration etc.

All reference standards shall be kept under responsible person to maintain proper
storage, transport, security, integrity, mishandling etc and the relevant records are also
to be maintained. The utmost care & protection shall be taken during handling &
preparation of standards to avoid cross contamination & health hazard.

The reference culture/microbial pure cultures are used establishing acceptable

performance of media, performance of the kits, validation of methods and
assessing/evaluating the laboratory performance. The reference microbial strains are
directly collected by laboratory from recognized national or international collection
(ATCC, MTCC, NCIM etc) with traceability. Generally the reference strains are received
in lyophilized stage or deep-frozen stage. If the reference strain has been thawed they
shall not be refrozen.

The reference microbial stains are used for Quality control; internal quality control and
performance of culture media in terms of productivity, selectivity, performance
evaluation and interpretation of result. The reference cultures are received either on
slant form or in lyophilized forms in vials.

On receipt the reference cultures, requires to revive in the laboratory. The active
cultures shall be sub-cultured on to recommended medium and incubated at
temperature specified. For lyophilized culture the outer surface of the vials is

23
GOOD FOOD LABORATORY PRACTICES (GFLPs)

disinfected, wrapped with thick cotton wool and neck of the culture vials is broken. The
contents transfer into 3 to 5 ml of recommended broth medium and mixed properly.
The suspension is to streak on the recommended agar plate and incubates at specified
temperature. Reference cultures to be checked for its purity, homogeneity, and typical
morphology. Subsequently they have to check for characteristic reaction in selective
medium and biochemical reactions. Whenever necessary, serological test as per
analytical procedure is also to be carried out to check the pure culture.

Sub-culturing from original stock in regular intervals as working culture for routine use
and records to be maintained. The intermediate checks on the purity and biochemical
characterization also to be checked. All the working cultures are properly locate with
name, date etc. & to be kept under proper storage condition.

All reference standards / pure culture stains are to be kept under responsible person to
maintain proper storage, transport, security, integrity, mishandling etc and the relevant
records are also to be maintained. The utmost care & protection shall be taken during
handling of microbial pure cultures for to avoid cross contamination & health hazard.
The laboratory has to maintain procedures / instruction for all.

[Sources of reference materials are at Annexure 8.1]

9. CALIBRATION AND PERFORMANCE ASSESSMENT RELATED REQUIREMENTS:

For accurate test results, lab shall be ensured that the equipments which are suitable for
intended purpose and capable of providing valid results, such instruments would be
regularly inspected, checked & calibrated accordingly. So laboratory should establish a
schedule for the calibration and performance verification of equipments/instruments,
which will be direct influence on the test results.

The calibrations to be done by in-house (internal)/external agencies/competent body

having traceability to a national / international standard (NABL accredited lab)
depending upon the type of equipment / instruments.

Laboratory management has to first segregate and classify the instrument, require
external and internal calibration. The interval / frequency of calibration has to decide
by the laboratory considering the equipment/instruments type, uses, experience and
need base, previous performance of the equipment etc.

Regarding external calibration laboratory has to collect the information from the
calibration agencies / laboratories to ascertain the facility / capability to fulfil the
laboratory requirements, status of accreditation, charges etc and based on the same the
competent calibration agencies / laboratories can offer for the calibration job. The
calibration for the instruments like balance etc is recommended to perform on site and

24
GOOD FOOD LABORATORY PRACTICES (GFLPs)

others may be sent to workshop/workplace. The laboratory shall ensure calibration

status / performance status of the instruments / equipments goes outside of the
laboratory control after return / put into service.

It is the laboratory responsibility to verify / check the calibration certificate in terms of

the lab requirements, traceability to the primary standard, ensure the capability /
calibration range, uncertainty, due date of next calibration (if require) etc and
laboratory has to evaluate the services. All records are to be maintained.

The sophisticated instruments such as GC / GC-MS, HPLC/ LC MS MS, AAS/ AES, ICP-
MS/ OES, UV-VIS Spectrophotometer etc. are recommended to check the performance
verification & operational qualification (OQPV) al least once in a year / depending upon
criticality of the uses of the instruments through the service providers / OEM. It is the
responsibility of the laboratory to verify / calibrate the instruments to ensure the
performance in regular basis / before put into use / analysis by use reference standards
etc.

The equipments like thermometer, pressure gauge, humidity meter, laboratory may
calibrate through external calibration agencies with proper traceability in regular
intervals / as per the lab protocol and the laboratory may use the same equipments as
standards for verification.

Where the certain criteria e.g. temperature, humidity etc has a direct effect in the result
of the test, the measuring device should be appropriate in quality to achieve the perfect
accuracy and those devices should be calibrated (internally/externally) traceable to
national/international standards.

In case of incubators, water baths, ovens, furnace etc. the stability of temperature,
uniformity of temperature distribution and time required to achieve the equilibrium are
to establish initially by experienced personnel. The documented monitoring system of
operating temperature is also be maintained.

Other equipments/instruments like conductivity meter, pH meter, refractometer and

other similar devices are to be verified in regular interval and prior to use with
reference standard.

Laboratory also ensures that the performance of the lab autoclave is also capable to
meet the specified time and temperature, pressure. Devices used for
controlling/monitoring of operating cycles are verified as well as calibrated. Laboratory
is also ensuring to maintain records of autoclave operation including
temperature/pressure and time for every cycle. In addition to monitoring the
effectiveness of the autoclave operation during its cycle also be checked by use of
chemical/biological indicator for monitoring sterilization/decontamination purpose
when a load has been processed.

25
GOOD FOOD LABORATORY PRACTICES (GFLPs)

The weight and balance are also to be calibrated traceably at regular interval / as per
the lab protocol. The performance of the weighing balance to be checked in regular
interval / every time before use.

The volumetric equipment such as dispenser/diluters, pipettes, volumetric flasks etc.

used in lab are to be checked to ensure the performance of the equipment. The
equipments shall be checked for the accuracy of the delivered volume against the set
volume and the precision of the repeat deliveries also be measured. Laboratory shall
obtain the certified specific tolerance supplies from manufacturer/companies and
calibrate through external agencies with traceability. The laboratory may also follow
internal verification and intermediate checks on accuracy. The lab also ensures to
provide a dedicated balance as reference to carry out the in-house calibration
verification of glass wares etc.

The status of calibration (internal / external) of all the equipments/instruments

including frequency of calibration, date of last calibration, due date of next calibration,
plan and procedures shall be maintained by the laboratory

10. PURCHASE OF CONSUMABLES/ EQUIPMENTS :

The laboratory should be maintained a proper system on purchase service & supplies
of all media, chemical, reagents & other requirements/appliance, consumables to avoid
undesirable, unconfirmed supplies of them and also ensure there should not be any
effect on the of test analysis / result.

Requirements like name of the chemicals, appliances, glassware’s, consumables, brand

name, quantity, Management, rate contract/ comparative quotation, quantity available
in stock shall be well documented by the laboratory.

Purchase shall be made in a systematic manner through a proper purchase / laboratory

protocol considering different aspect like quarter/half year/annual requirements,
pattern of previous consuming, approximate cost etc. Regarding purchase of
equipments / instruments laboratory shall be need based considering the laboratory
requirements, indented for use, accuracy / sensitivity, sophistication / latest version,
future plan / work load etc.

On arrival of all the purchase materials, the laboratory shall be received & verified with
reference to the order placed and the relevant criteria like quantity, brand, code,
certificate of analysis, date of expiry , guarantee / warranty, condition of the items on
arrival etc. The necessary entries / documents shall be maintained.

All instructions related to the purchase like storage, handling, inventory, responsibility
etc shall be maintained & documented by the laboratory and followed in a systematic
way.

26
GOOD FOOD LABORATORY PRACTICES (GFLPs)

The items/ supplies will effect on test result and the laboratory shall be evaluated the
same to ensure the quality. Records are also to be maintained.

It is the responsibility of the laboratory to verify the certificates, reports etc related to
services opt by the laboratory from the calibration agencies, equipment / instrument
manufacturer / service providers etc..

Laboratory shall evaluate the performance of the supplier & service providers in regular
intervals and approved list supplier & service providers with all details shall be
maintained.

The laboratory must be maintained procedures / instruction & documents / records for
all.

11. SAMPLING & SAMPLE HANDLING:

Sampling for testing or analysis is a process of taking a representative portion from a

material or product to test (e.g. by physical measurements, chemical analysis,
microbiological examination), typically for the purposes of identification, quality
control, or regulatory assessment. The sampling is a significant role in testing activities
as it reflects the ultimate test results.

It is not mandatory that all the laboratories shall be involved in sampling activities.
However the laboratory involves in sampling shall maintain at least the following

The laboratory policy & declaration on sampling.

The laboratory should have authorized personnel / sampler with adequate knowledge,
training etc on sampling.

The laboratory shall maintain the sampling plan & procedure in respects of the products
/ materials that shall include selection, withdrawn & preparation of samples during
sampling. The same shall be based on appropriate statistical method / regulatory
guidelines / references.

Work instruction shall be maintained for the personnel involve in sampling activities.

The laboratory should have all facilities like tools, equipments / instruments etc
requires for various sampling.
The laboratory shall maintain the relevant data & operation related to sampling,
procedure use, location, date / time of sampling, identification of sampler, other specific
requirements like environmental conditions, transportation, statistics the sampling
procedures are based upon etc and documents shall be maintained.

27
GOOD FOOD LABORATORY PRACTICES (GFLPs)

All incoming samples shall receive through the receiving section maintained and
supervised by laboratory responsible person. On receiving section the laboratory
responsible personnel initially checked the relevant overall criteria like sample
identity/labelling, mode of transportation, condition of the sample including packaging,
sample quantity, verification of fees (whenever necessary), parameter to be tested etc
against the customer declaration / requirements. Any abnormalities / deviation /
doubts from the normal condition, suitability of the sample for tests etc , the same shall
be clarified from the customer / laboratory responsible personnel before accepting the
samples for registration / testing. In case microbiological test samples, the same shall
be received in the sterilized container/sample box etc. The laboratory documentation
system shall includes all relevant information such as customer details, date of receipt,
condition of the sample on receipt, sample quantity, transportation , parameters to be
tested ,observation/remark (if any) etc.

The laboratory shall maintain a system on traceability of all accepted samples and the
same shall be maintained throughout the retention of the sample in the laboratory
without any confusion.

The laboratory must have all infrastructures, facilities for storage and preserve the
samples depending on the physical, chemical and microbiological properties to
maintain the sample integrity, security, avoid loss / damage, deterioration etc. The
laboratory must have proper documented system on retention & disposal of the tested /
remnant / reference samples. The retained samples may also use for retesting and the
internal quality assurance purpose. Wherever necessary the specific storage like deep
freezer, refrigerator etc shall be provided and during storage the environmental
conditions shall be maintained, monitored & documented.

The laboratory must have documented system, procedures, instructions & facilities for
conditioning and preparation of sample according to the standard method or laboratory
protocol to maintain the homogeneity, avoid loss / damage of the test sample.

The laboratory should ensure to maintain a proper documented system procedure for
handling of test items including sample receiving, storage, transportation, retention /
disposal, integrity, avoid and prevent loss/damage of the test samples.

11.1 General Principles:

The identity, homogeneity and integrity of the materials being handled by the
laboratory must be ensured throughout the time they are under the control of the
laboratory e.g. from sample receipt to data report and authorized disposal of the
surplus material.

28
GOOD FOOD LABORATORY PRACTICES (GFLPs)

The analytical data report must reflect the composition of the received material as a
whole.

11.2 General:

Sampling is a defined procedure whereby a part of the substance material or product is

taken to provide for testing or calibration of a representative sample of the whole.
Sampling may also be required by the appropriate specification for which the substance
material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis)
the sample may not be representative but is determined by availability.

The sampling procedure should describe the selection, sampling plan, withdrawal or
preparation of sample from a substance, material or product to yield the required
information. If the customer requires deviations, additions or exclusions from the
documented sampling procedure, these shall be recorded in detail with appropriate
sampling data and shall be included in all documents containing test and /or calibration
results.

The laboratory shall have the procedure for recording relevant data and operations
relating to sampling that forms part of the testing and calibrations that is undertaken.
These records shall include the sampling procedure used, the Identification of the
sampler, environmental conditions (if relevant) and diagrams and other equivalent
means to identify the sampling location as necessary.

11.3 Samples may be conveniently classified under two broad divisions:

I. Formal samples – These are samples taken to determine if the food complies
with national or local laws or regulations and
II. Informal Samples – These are samples taken for the purpose of monitoring or as
part of survey work.

Formal follow-up samples can be taken if informal samples receive adverse

laboratory reports. Formal or informal sample are also taken under others such
as follow-up to a consumer complaint.

11.4 Sample Collection:

Work scheduling is greatly facilitated by arranging a sampling programme for routine

monitoring with the inspectorate. As part of a general food control programme there is
need to:

1. Regularly inspect foods at different stages in the manufacture and

distribution chains, using planned surveillance programme.

29
GOOD FOOD LABORATORY PRACTICES (GFLPs)

2. carry out general surveys of the quality of the food supply through
random sampling and analysis.
3. monitor certain specific problem areas with regards to food safety –
specific potential risks, e.g. level of metallic contaminants pesticide
residues, mycotoxins etc.
4. inspect foods for export, for certification of quality (if needed)
5. inspect food import. This is best done on all imported consignments by
formal sampling carried out systematically in a manner representative of
the lot.
6. formal sampling should also be done on locally produced food products
based on the food inspector’s observations or because a random or
investigatory samples under the regular programme was unsatisfactory
or the product is one that requires thorough surveillance. Analysis of
formal or informal samples is also necessary in an emergency such as an
outbreak of food poisoning.

11.5 Quantity of Samples to be collected, product wise is shown at Annex 11.1

(Ref. Annex II of FSSAI Manual on General Guidelines on Sampling)

11.6 Sample Receipt and Assignment:

Receipt and identification of a sample have to be clear and unambiguous for the
quality assurance to be maintained. The laboratory register of test materials should be
of a type where papers are numbered and cannot be removed. Entries on computer-
based registers must be protected against deletion and /or alteration. A back-up copy
must be produced and stored separately from the original.

When a sample is received for analysis, there must be a system to track the sample
throughout its initial stage, analysis and later reserve storage. This is usually
embodied in a record-keeping system, which is keyed to a unique identification
number assigned to the sample at the time of sampling. This number can be sequential
(i.e., 00001 to 9999) or can be devised to give information (i.e., 024-95-07) the 24th
sample taken in 1995 under sampling programme No7) The record must show the
movement of a sample, its receipt, assignment to a laboratory person for analysis,
return to the sample and eventual dispersal. One of the administrative staff should be
given this record – keeping function and closely supervised by the laboratory Head. It
is preferable to use a card system rather than a logbook as cards are more flexibly
handled. There are certain items of information, which should be on each card:

1. Sample number
2. Product name
3. Date Sampled

30
GOOD FOOD LABORATORY PRACTICES (GFLPs)

4. Date received at the laboratory

5. Type of sample (Survey, Complaints etc.)
6. Method of storage (dry, refrigeration, freezing etc.)
7. Storage location (coded for easy finding)
8. Date assigned for analysis
9. To whom assigned (the analyst should initial to show receipt)
10. Date retuned (from analysis)
11. From whom returned (maybe different from the original analyst)
12. Reserve storage method and location
13. Final disposal of samples, method and date.

Example of a typical sample record is given at Annex 11.2 (ref. Appendix 5.1 of FAO
14/14)

11.7 Control and Storage:

The storage of test materials is of major importance if the analytical data produced is to
reflect and be traceable to the original sample. Deterioration of test materials
invalidates any results. Therefore; test materials must be stored so as to ensure their
integrity, safety, legality and stability. The laboratory must guard against deterioration,
contamination and loss of identity. Special care will be needed where trace analysis is
involved in order to ensure that extraneous materials do not contaminate the test
materials and equipment.

There are three basic forms of storage - room temperature (dry room), refrigeration
and freezing. The QA programme should specify the conditions to be used (Annex 11.3 -
reference Appendix 5.3 of FAO 14/14). There are also problems associated with the
type of container in which food can be stored. Foods that contain fats and oils should
not be stored in copper or metallic vessels and foods that easily desiccate such as fruits
need to be stored in ways, which avoid loss of water.

Perishable, unfrozen food must be maintained at 0C – 4C and frozen food kept

preferably at -18 C or below. All perishable items should be examined within 36 hrs. Of
collection .Perishable samples that have been examined within 36 hrs after being
sampled should be frozen, canned. Dry non-perishable foods maybe stored at room
temperature before analysis.

The test material could also be dried and stored pending analysis, if analysis will not be
affected by drying.

Special conditions apply to test materials, which are to undergo microbiological

examination as well as chemical analysis. If a test material is to be stored frozen and a

31
GOOD FOOD LABORATORY PRACTICES (GFLPs)

number of separate analyses are to be performed, it is preferable to sub-sample before

freezing.

All test materials when stored must be properly and indelibly labelled so that
identification is not lost .The most effective method of labelling maybe to place the label
in its own plastic bag, inside the test material container, but separated from the food by
a suitable layer.

The sample is then stored until it can be matched with a suitable test note containing all
the above information and any other relevant information required for analysis and
interpretation of the results. The test note should preferably be of the type that
incorporates enough space for the test results and observations. The sample and the
test note should (when matched if they arrive at different times) be clearly and indelibly
marked with a registration number and passed to the analyst. From this point onwards,
the analyst will identify everything pertaining to that sample with the laboratory
number.

11.8 The Analytical Sample (Test Portion):

Before removing the test portion (s) for analysis, the analyst must be certain that all
records are in order, integrity has been maintained containers are intact and sealed (if
any) ,unbroken.

Any ambiguity in the analytical requirement must be resolved, e.g. with canned pickle in
oil, is the analysis to be done on the pickle, oil or the whole contents of the can.

For analysis, the analyst first removes a test portion. If the test material comprises more
than one item (fruit, vegetable etc.) the test portion should contain material from each
item – usually achieved by comminuting a number of items and removing a portion.
After the test portion has been removed, the remaining test material is returned to the
storage.

11.9: Referral of the Test Material:

On occasions it may be necessary to pass a test material to another laboratory for some
specialized analysis or because of some analytical facility not being available with the
laboratory or because of overload of work. Unless the other laboratory is a part of the
same QA programme or the two laboratories are accredited by the same (or equivalent
schemes), this referral would mean that the test portion sent for that analysis ceases to
be quality assured by the parent laboratory. This should be made clear in the analysis
report to the customer.

32
GOOD FOOD LABORATORY PRACTICES (GFLPs)

11.10 Test Material Disposal:

Sample disposal is relatively a simple matter. The only problem arrives when there is a
hazard involved in the destruction or the sample remains must have specific treatment
e.g. a sample of groundnut heavily contaminated with alfatoxin. Any residual material if
valuable such as flavouring concentrate maybe required to be returned to the
originator. The register should therefore have a column in it for details of when, how
and where the test material was disposed.

11.11 Documentation for QA Programme:

1. Register for sample receipt: Test material identification

2. Flow chart of the sample submitted for laboratory examination
3. Storage conditions for food test materials

12.0 QUALITY ASSURANCE MEASURES:

12.1 General Principles:

The QA programme for a laboratory covers all the policies and activities, which can
affect the quality of its output.

12.2 Definition and Scope:

A QA programme maybe defined as a mechanism used to ensure that the data are fully
reliable, suitable for the intended purpose, presented on time and at an acceptable cost.
It is a formal, planned activity whose purpose is to provide assurance that the quality
control programme is actually affected and is designed to fit the needs of the laboratory.

The scope of the quality assurance system has to be developed in such a way that there
is confidence that whenever data are reported

1. the identity and integrity has not been compromised

2. the analysis has been conducted by member of the staff who is competent
for the task
3. the equipments and the methods are appropriate and are working properly
4. the laboratory can demonstrate its current capability to produce valid data.

The format adopted in meeting these requirements may vary from laboratory to
laboratory.

33
GOOD FOOD LABORATORY PRACTICES (GFLPs)

Each laboratory (or group of laboratories) meets different requirements, operates

within a different organizational environment, experiences different constraints and
should have a QA programme, which takes account of these factors.

There are certain factors, which are common

1. The use of validated methods

2. The use of standard operating procedure (SOP) in the laboratory
3. Calibration and traceability of measurement (including use of certified
reference material)
4. External assessment of performance

While facilities exist for accreditation of laboratories for particular types of work, it is
usual to find requirements for these features within this scope of accreditation process
along with the requirements for topics which may include organization and
management, laboratory accommodation and environment, equipment maintenance,
handling of test materials, test methods and quality control procedures (and method
performance characteristics), staff training and performance, security, records and
reports, sub-contracting of work , outside support services , handling of complaints ,
quality audit and system review.

12.3 Preparation:

QA Programme is concerned with everything that goes on in the laboratory, which may
affect “Quality”. Each member of the staff involved in the QA programme must be

1. clear about what they are expected to do

2. know how to do it and
3. be able to show that they had done it properly

Documentation is a major feature of QA programme. Formulation of a QA programme

should contain three essential components

a) Prevention, which requires an orderly programme of planning and

positive actions before or during analysis to ensure that all analytical
systems are performing appropriately, easy calibration and maintenance
of instruments use of reference materials and training.

b) Assessment, a form of control that includes periodic checks on the analyst

performance e.g. analysis of check samples and validation of
methodology.

c) Correction, an action taken to determine cause (s) of quality defects and

to re-establish proper functioning of analytical operations e.g. trouble

34
GOOD FOOD LABORATORY PRACTICES (GFLPs)

shooting to correct malfunctioning equipment, re-evaluation of

methodology and re-training.

12.4 External Proficiency Testing:

Proficiency testing is the part of QA programme, which looks at the accuracy

(correctness’) of the results actually being reported by the laboratory on real test
materials. An independent external assessment of the correctness of the typical result
provides an impartial test of analytical quality: this is done by proficiency testing
scheme, i.e. methods of checking laboratory testing performance by means of inter
laboratory tests. This includes comparison of a laboratory‘s results at intervals with
those of other laboratories. Procedures used when analyzing test materials for such a
scheme are those normally used by the laboratory.

The proficiency testing is likely to grow in importance because of regional and

international developments which require laboratory data to be mutually acceptable
between nations for many regulatory purposes .A harmonized protocol for the
proficiency testing of the chemical laboratories has been prepared by joint ISO /AOAC
International/IUPAC Working Group (November 1992, ISO /REMCO, N263). This
identifies and explains the major features recommended for proficiency testing scheme.
The major features of the protocol are listed in Annex 12.3 (Ref. Appendix 10.1 of FAO
Manual14/14)

12.5 Internal Quality Control Checks:

Blank Analysis:

Blanks are to included in analytical methods .A blank is characterized as a sample

included in the analytical processes, which has all the properties of the actual sample
except that it does not contain the substance of interests.

Duplicate Analysis:

Duplicate sample analysis is the analysis of the same sample twice in order to determine
the precision of the analysis.

Spike Analysis:

A sample is split into two sub samples in the laboratory. One is analyzed according to
the specified procedure. The other is treated by adding a known amount and
concentration of the indicator being measured, running this specified procedures. This
should increase the concentration in the spiked sample relative to the unsp sample, by a
predictable amount. Usually 10 percent of the sample are split and spiked. They are
used to test the accuracy of the laboratory method.

35
GOOD FOOD LABORATORY PRACTICES (GFLPs)

12.6 External Performance Evaluation:

In order to verify that a laboratory possesses the capability to provide accurate and
reliable test data in its day to day operations and to maintain high standards of
performance, a competent, disinterested third party is necessary to evaluate
laboratories based on personnel, physical facility, instrumentation and quality
assurance / quality control programme, and the laboratory’s performance. For this
purpose, an organization should participate in inter laboratory comparisons of the
proficiency testing programs.

12.7 QA Manual:

Each laboratory with a QA programme should have a manual that documents the
operations of the laboratory. A typical manual might consist of the following:

a. Title page with signatures of all approving officials and date of issue (Annex
12.1)-Ref: Appendix 2.2 of FAO manual 14/14
b. Table of contents
c. Organizational structure and exactly where the laboratory fits into this structure
d. Objective of the quality assurance programme
e. Essential elements of the QA Programme (Annex 12.2)-Ref Appendix 2.1 of FAO
manual 14/14.
f. Documentation forms
g. Performance and frequency of Audit
h. Corrective and follow-up action

A Statement of the QA Policy both general and specific is needed in the QA Manual; the
objective of the laboratory should be clearly defined. The principal objective of the
laboratory, for example, is to produce reliable results

12.8 Implementation:

Actual implementation of the QA programme is a co-operative effort of the

management, and member of QA unit, section leaders and analyst. Management decides
the amount of resources to be allocated to the QA Programme. This decision determines
the nature and the size of the QA unit. In formulating the QA Programme, this unit
receives technical input from the analyst. Once formulated by the QA Unit and approved
by the management the QA programme is ready for introduction.

Analysts are responsible for day-to-day maintenance of the programme. The QA Unit
periodically monitors this adherence and makes its report and recommendations to the
management, which then decides on the action to be taken so as to achieve compliance
with the programme.

36
GOOD FOOD LABORATORY PRACTICES (GFLPs)

12.9 Revision of the QA Manual:

The QA Manual must be designed so that the change is easily accommodated. It is

essential that organizational pattern emerge, workload shifts and methodology
develops. The QA Manual can react rapidly to these changes in the work of the
laboratory.

12.10 Documentation Required or the QA Programme:

 Laboratory elements to be considered in the QA Manual

 QA Manual cover and contents pages (Annexe 12.1)
 A statement of QA Policy

13.0 LABORATORY RECORDS:

13.1 General Principles:

All the information that has any particular relevance to the materials and the analysis
performed on them must be documented in a systematic fashion at any point in its
passage though the laboratory. Records must allow a test material to be traced back to
its arrival and any information that arrive with it.

Records should be such that if the need for reanalysis arises, it could be done under the
same conditions and in the same way as before. Records must be retained and protected
from misuse, loss or deterioration for an agreed time.

13.2 Sample Collection Records:

Responsibility for sample collection generally falls outside the food-control laboratory;
hence it is not covered here.

13.3 The Analysts Worksheets:

The analyst worksheet provides a written account of the laboratory analytical results.
Certain requirements apply to all worksheets.

1. All the basic information must be recorded directly on the worksheet before
analysis has begun.
2. As soon as the worksheet is obtained it should be initialled.
3. All entries should be clearly legible and made in permanent ink.

37
GOOD FOOD LABORATORY PRACTICES (GFLPs)

4. No entries should be erased or over -written if an incorrect entry is made. The

analyst should draw a line through the incorrect entry; write above it the correct figure
or word and then date and initial the corrected entry.
5. Data should not be discarded without explanation.
6. The exact analytical method should be referenced clearly and completely. If the
method has not been published or is not covered by SOP it should be written in full on
the worksheet or as an attachment to the worksheet.
7. If the analysis has been made in duplicate or triplicate etc. the result of each
analysis as well as the summary of all result must be recorded.
8. If more than one analyst is involved in analysis the worksheet must indicate
which analyst broke this seal and which analyst performed each segment of the
analysis.
9. Any continuation sheets that accompany the analyst worksheets should be
numbered in a consecutive series e.g. 1 of 8, 2of 8, 8 of 8 pages. An example of ex analyst
worksheet is shown at Annex 13.1(Ref: Appendix 11.1 of FAO manual 14/14)
10. Worksheets are check for accuracy, completeness and compatibility with other
documents by the supervisor or the designated representative.
11. The date on which the analyst submitted the worksheet to the supervisor is
indicated.
12. The exact method used is referenced. Any modification to the referenced method
is stated and the reason for the modification is given.
13. All calculations are clearly shown with the proper number of significant figures
used.
14. The use of controls and their results are specified.

13.4 Analyst relies increasingly on instruments, which produce a hard copy record of
the instrumental readings. Taking chromatographic charts as an example, this must be
clearly labelled (test material number, analyst, date and any other necessary identifiers)
and stored in a logical sequence. Chromatograms of Standards, recoveries and sample
extracts must be cross- referenced to each other and to the responsible analyst
laboratory notebook to allow for easy checking of results. The full chromatographic
conditions employed must be stated on the chromatogram or must be readily
obtainable from the analyst’s notebook.

14 LABORATORY REPORTS:

14.1 General :

The laboratory report is a condensed version of the data appearing in worksheets and
laboratory notebooks. It must contain all the information normally necessary for the
customer to utilize the result it contains

14.2 The format of laboratory report typically include the following

38
GOOD FOOD LABORATORY PRACTICES (GFLPs)

 Name, Address of the Laboratory

 Name, Address of the customer
 Certificate/Report Number
 Page Identification (Page X of Y)
 Sample received details (Dates, Names of deliverable, receiver)
 Unambiguous identification of sample / test material (Description,
Laboratory Number etc.)
 Analysis conducted, Methods, Procedures any deviation from standard
practices.
 Preparation of test material, taking of test portions
 Results
 Uncertainty of measurements
 Comments on significant of findings (if expected by the customer)
 Date of report
 Authorizing signature

14.3 Retention of Laboratory Record:

The sequence of records should form a continuity of documentation to produce a clear,

accurate and in-disputable history of the test material with all aspects of documentation
in agreement.

All sample registers worksheets, reports and associated documents must be retained for
a period, which is determined by the management in consultation with the customers
and is documented.

Storage of such material should follow the normal rules of archiving in terms of
indexation, traceability, security, appropriate levels of protection against fraud and
tampering, from fire, flood etc. Backup copies must be held of any records stored as
electronic signal on magnetic media. This should be renewed at appropriate intervals.

Dates and signature of individuals who withdraw and return documents in storage must
be recorded.

14.4 Documentation for QA programme:

 Analyst worksheet
 Laboratory report
 Procedures for checking of results
 Procedures for authorization for report
 Period for retention of documents
 Procedures for archiving and disposal of documents.

39
GOOD FOOD LABORATORY PRACTICES (GFLPs)

Annexure 8.1

A. Sources for Biological Reference Material:

1. Within India reference strain can be obtained from IMTECH, Chandigarh

(www.imtech.res.in);

2. National Chemical Laboratory, Pune (www.ncl-india.org);

3. Christian Medical College, Vellore (www.cmch-vellore.edu);

4. Central Research Institute, Kasauli, HP (http://mohfw.nic.in);

5. National Institute of Communicable Diseases, Delhi (www.nicd.ac.za)

[Ref: - NABL 102]

B. Sources for Chemical Reference Material:

NIST – Trace Certified Reference Materials (CRMs) may be used

C. Sources for Physical Reference Material:

National Physical Laboratory, Delhi (www.nplindia.org)

40
ONLINE TRAINING PROGRAMME
on
Minor Forest Produce Processing
ORGANISED BY :

Indian Institute of Food

Processing Technology (IIFPT)
Packaging of Minor Forest
Products
BIDHAN DAS
DEPUTY DIRECTOR & REGIONAL HEAD
INDIAN INSTITUTE OF PACKAGING,
KOLKATA CENTRE
 PRESENTATION
BY

PROF. N. C. SAHA
DIRECTOR

MOC&I,DELHI 4TH APRIL, 2013

BACKGROUND
REGISTERED AS A SOCIETY AS PER SOCIETIES REGISTRATION ACT, 1860.
AN AUTONOMOUS BODY IN THE FIELD OF PACKAGING AND WORKING UNDER
THE ADMINISTRATIVE CONTROL OF MINISTRY OF COMMERCE & INDUSTRY,
GOVT. OF INDIA.
ESTABLISHED IN 1966 WITH ITS HEADQUARTERS & PRINCIPAL LABORATORIES
IN MUMBAI.
1st REGIONAL CENTRE WAS OPENED AT CHENNAI IN 1971.
2nd REGIONAL CENTRE WAS OPENED AT KOLKATA IN 1973.
3rd REGIONAL CENTRE CAME AT DELHI IN 1986.
4th REGIONAL CENTRE WAS OPENED AT HYDERABAD IN 2006.

5TH REGIONAL CENTRE WAS OPENED AT AHMEDABAD, GUJRAT IN 2017.

5th REGIONAL CENTRE FOUNDATION STONE LAID AT BANGALORE IN 2013 AND
THE CONSTRUCTION IS ON PROGRESS.
6th REGIONAL CENTRE WILL BE SET UP AT GUWAHATI. RE-ALLOTMENT LETTER
OF THE LAND IS TO BE RECEIVED FROM GOVT. OF ASSAM.
REGIONAL CENTRE WILL BE SET UP AT KAKINADA, AP. ALLOTMENT
7th

LETTER OF THE LAND IS YET TO BE RECEIVED.

8TH REGIONAL CENTRE IS BEING ESTABLISHED IN VARANASI, UP
BRANCH OFFICES
OBJECTIVES
TO PROMOTE THE EXPORT MARKET BY WAY OF
INNOVATIVE PACKAGE DESIGN AND DEVELOPMENT.

TO PROMOTE THE EXPORT OF PACKAGING MATERIALS

AND MACHINERIES BY WAY OF PARTICIPATION IN
OVERSEAS EXHIBITION AND ALSO ORGANISING
NATIONAL AND INTERNATIONAL EXHIBITIONS IN INDIA.

TO INCREASE THE STRENGTH OF TECHNICAL

MANPOWER THROUGH PACKAGING EDUCATION IN
INDIA.

TO PROMOTE PACKAGING INDUSTRY THROUGH

TECHNICAL SERVICES IN INDIA.

TO UPGRADE THE OVERALL STANDARDS OF

PACKAGING AT NATIONAL LEVEL.
TWO MAJOR ACTIVITIES
TRAINING & EDUCATION.

RESEARCH AND DEVELOPMENT

TESTING & CERTIFICATION OF PACKAGING MATERIALS &
PACKAGES.

TECHNICAL CONSULTANCY ON PACKAGE DESIGN &

DEVELOPMENT.
APPLIED RESEARCH & SHELF LIFE STUDIES OF FOOD,
PHARMACEUTICAL & COSMETIC PRODUCTS
NATIONAL AND INTERNATIONAL EXHIBITIONS I.E
“INDPACK” & “INDIAPACK”

ORGANISING NATIONAL PACKAGING AWARDS I.E

“INDIASTAR” & “PACMACHNE” FOR EXCELLENCE IN
PACKAGING
ACTIVITIES
TRAINING & EDUCATION
TWO YEARS POST GRADUATE DIPLOMA IN PACKAGING (PGDP)
18 MONTHS DISTANCE EDUCATION PROGRAMME (DEP)
3 MONTHS ANNUAL INTENSIVE TRAINING CERTIFICATE
PROGRAMME (ITC)
SHORT TERM TRAINING PROGRAMMES AS PER REQUIREMENTS
OF INDUSTRIES.
INTERNATIONAL TRAINING PROGRAMMES FOR WPO,APF, INDO -
AFRICA FORUM SUMMIT, GOVT OF SRI-LANKA, BANGLADESH ETC
NATIONAL AND INTERNATIONAL CONFERENCES.

TESTING AND CERTIFICATION

AUTHORISED BY DG SHIPPING & DGCA,GOVT OF INDIA AS
COMPETANT AUTHORITY FOR TESTING OF BULK PACKAGES FOR
CARRIAGE OF DANGEROUS GOODS FOR EXPORT AND ALSO TO
ISSUE UN CERTIFICATE AS A MANDATORY REQUIREMENT
ACCREDITATED TO NABL AND BIS TO ISSUE TEST REPORTS.
ACTIVITIES
CONSULTANCY SERVICES
FORMULATION OF TECHNICAL SPECIFICATIONS OF PACKAGES
FOR EXPORT OF FRESH AND VEGETABLES, SPICES, TEA, MARINE
PRODUCTS - FOR APEDA, MPEDA, SPICES BOARD,TEA BOARD ETC
RESPECTIVELY.
TECHNICAL AUDIT OF PACKAGING SYSTEMS TO HIGHLIGHT THE
SHORTCOMINGS AND TO SUGGEST SUITABLE MEASURES TO THE
INDUSTRIES.
RESEARCH AND DEVELOPMENT
DEVELOPMENT OF ALTERNATIVE TYPE OF PACKAGING
MATERIALS BASED ON JUTE,COIR AND OTHERS IN ASSOCIATION
WITH IJIRA,COIR BOARD ETC.
DEVELOPMENT OF SUITABLE PACKAGE TO ENHANCE THE SHELF-
LIFE OF TENDER COCONUT WATER WITH IIT,MUMBAI ,
SPONSORED BY MOFPI.
DEVELOPMENT OF MODIFIED PACKAGING SYSTEM FOR THE
EXPORT OF CHILLED MEAT PRODUCTS, SPONSORED BY APEDA.
PROPOSED PLAN
TO GET THE RECOGNITION AS “ INSTITUTE OF NATIONAL
IMPORTANCE” AS PER ACT OF PARLIAMENT.
TO COMMENCE DEGREE COURSE I.E FOUR YEARS B.TECH IN
PACKAGING TECHNOLOGY & MANAGEMENT BY 2017-18
TO COMMENCE 2 YEARS M.TECH PROGRAMME IN FIVE
DISCIPLINES :
- FOOD PACKAGING
- PHARMACEUTICAL & COSMETICS PACKAGING
- INDUSTRIAL PACKAGING
- PACKAGING OF CHEMICALS & ALLIED PRODUCTS
- PACKAGE PRINTING & GRAPHICS.
ELIGIBILITY FOR B.TECH ( 12 STANDARDS THRO JEE)
ELIGIBILITY FOR M.TECH ( THRO GATE / ENTRANCE)
- B.TECH IN FOOD TECHNOLOGY,PRINTING TECHNOLOGY,
POLYMER SCIENCE, MECHANICAL, ELECTRICAL,
ELECTRONICS etc.
PACKAGING INDUSTRY
RAW MATERIAL MANUFACTURERS

PACKAGING MATRIALS CONVERTERS

PACKAGING USERS INDUSTRY

Packaging Materials

1)Scientific Packaging Materials

2) Traditional Packaging Materials

ANCILLARY PACKAGING MATERIALS
CAPS & CLOSURES
LABELS
BOPP SELF ADHESIVE TAPES
STRETCH & CLING FILMS
STRAPS, CLIPS & HOOKS
BUBBLE FIMLS, THERMOCOLE & FOAM
CUSHIONING MATERILAS
TRADITIONAL PACKAGING
MATERIALS

EARTHEN POT
BAMBOO BASKET / CANE BASKET
LEAVES
WOODEN BARREL / BOX
JUTE BAGS
TRADITIONAL PACKAGING MATERIALS

Traditional Packaging Scientific Packaging

TRADITIONAL PACKAGING MATERIALS
TRADITIONAL PACKAGING MATERIALS
TRADITIONAL PACKAGING MATERIALS
TRADITIONAL PACKAGING MATERIALS
SCIENTIFIC PACKAGING MATERIALS
SCIENTIFIC PACKAGING MATERIALS
SCIENTIFIC PACKAGING MATERIALS
SCIENTIFIC PACKAGING MATERIALS
Paper
Glass
Metal
Plastic
 Forest Produce (FP)
Section 2(4) of the Indian Forest Act 1927 defines only
"forest-produce" and this term connotes to those products
whether found in, or brought from a forest such as
timber, charcoal, caoutchouc, catechu, wood-oil, resin,
natural varnish, bark, lac, mahua flowers, mahua seeds,
kuth and myrabolams,
trees and leaves, flowers and fruits, and all other parts or
produce of trees,
plants not being trees (including grass, creepers, reeds and
moss), and all parts or produce of such plants,
wild animals and skins, tusks, horns, bones, silk, cocoons,
honey and wax, and all other parts or produce of animals,
and
peat, surface soil, rock and minerals (including lime-stone,
laterite, mineral oils), and all products of mines or
quarries;
 Minor Forest Produce (MFP)
Minor Forest Produce (MFP) is a subset of forest
produce and got a definition only in 2007 when
the Scheduled Tribes and Other Traditional Forest
Dwellers (Recognition of Forest Rights) Act, 2006, was
enacted. Section 2(i) of the said Act defines a Minor
Forest Produce (MFP) as all non-timber forest produce
of plant origin and includes bamboo, brushwood,
stumps, canes, Tusser, cocoon, honey, waxes, Lac,
tendu/kendu leaves, medicinal plants and herbs, roots,
tuber and the like.
Thus, the definition of “minor forest produce” includes
bamboo and cane, thereby changing the categorization
of bamboo and cane as “trees” under the Indian Forest
Act 1927.
MSP for Minor Forest Produce
Minor forest produce includes non-timber
items such as bamboo and other grasses, edible or
useful roots, seeds, fruits, flowers and plants.

A number of people from Scheduled Tribes and

other forest-dwelling communities depend on
the collection and sale of such items for
their livelihood.
Recommended style of CFB for
PACKAGING of Pineapples
Recommended style of CFB for
PACKAGING of Pineapples
Recommended style of CFB for
PACKAGING of Pineapples
EPE FOAM JACKET
 Minor Forest Products
Minor forest products include all products obtainable from the
forests other than wood and thus comprise products of
vegetable and animal origin.
Some of the important forest products of minor nature are
follows:-
Plant Products:- grasses, bamboos, oils, gums, spices, tannins
and resins etc.
Animal Products:- honey, lac, wax, Ivory, horns, hides etc
 Packaging of Honey
Physical and Chemical Properties :-
At room temperature, honey is a supercooled liquid, in which the glucose
precipitates into solid granules.
This forms a semisolid solution of precipitated glucose crystals in a
solution of fructose and other ingredients.
The density of honey typically ranges between 1.38 and 1.45 kg/l at 20 °C
Honey has the ability to absorb moisture directly from the air, a
phenomenon called hygroscopy.
The average pH of honey is 3.9, but can range from 3.4 to 6.1
Honey from different plant source contains volatile organic
compounds (VOCs) which play a primary role in determining
honey flavors and aromas.
 Packaging of Honey
GLASS PACKAGING :-
Excellent moisture & gas barrier properties to protect the
honey from external environments.
Hygienic and suitable for sterilization
Non reactive & transparent
Good protection power
Issues:-
It is relatively heavy
Glass is fragile so easily broken
Release alkali to aqueous
preparation
PLASTICS CONTAINERS FOR HONEY
Generally PET or HDPE or PP containers are used for
packaging of honey.
PET (Polyethylene Terephthalate)
lightweight , transparent
More impact resistant
Helps protect food or liquids inside the packaging.
 HDPE (High-Density Polyethylene)
Low cost
Moisture resistance
Good chemical resistance
Food grades available
Good Stackability
Available in different shapes
Issues:-
Poor weathering resistance
Flammable
Sensitive to stress cracking
Difficult to bond
 PP (Polypropylene)
Flexible, Low Friction
Heat resistant
Acid resistance and cheap
Highly resistance to corrosion
High tensile strength
Good ESCR
Integral – Hinging properties
Issues:-
• It is susceptible to UV
degradation
• poor bonding properties
Packaging of Spices- Cardamom, chilies etc.
Characteristic of Spices :-
• Spices are aromatic substances of vegetable origin, derived from plant
parts - leaves, bark, fruit, flower, stem, root, seeds
• They contain volatile oils which impart aroma and flavour to the product.
• They are used as condiments and seasonings and form an essential part of
food preparations as they add flavour, taste and appearance.
• They have good anti-oxidant and preservative properties.
• They are also used for medicinal purposes
SPOILAGE FACTORS / CHARACTERISTICS
1) MOISTURE CONTENT
Spices, specially powders are hygroscopic in nature and
pick-up moisture from the atmosphere resulting in
sogginess and caking or lumping of the powder. Moisture
pick up also results in loss of free-flowing nature of the
spice powder.
2) LOSS OF AROMA/FLAVOUR
Spices contain volatile oils which impart aroma/flavour
to the product. Loss in volatile oil content or oxidation of
some aromatic components results in aroma and flavour
loss.
3) DISCOLOURATION
Some spices like green cardamom, red chilies, turmeric, saffron contains
natural pigments.
On exposure to light there is loss of colour and deterioration.
4) INSECT INFFESTATION

Spices are prone to spoilage due to insect attack.

This can be accelerated due to high humidity, heat and oxygen.

5) MICROBIAL SPOILAGE
Due to high humidity of about 70% and above moisture absorption takes
place. Beyond a certain level of moisture content, microbial growth occurs
resulting in spoilage.
BULK/ INSTITUTIONAL PACK FOR WHOLE & GROUND SPICES
Traditional Pack New Trend/Alternate
Jute sack/bag, Wooden box, Tin Container Plastic woven sacks, bag-in box,
paper bag, Plastic pouch
 CONSUMER PACK- WHOLE SPICES
TRADITIONAL NEW TRENDS / ALTERNATES
Pouch of Mono Film Laminated Printed Pouch, Lined Carton,
Pouch in Carton
 CONSUMER PACK- GROUND SPICES
TRADITIONAL NEW TRENDS / ALTERNATES
Pouch of Mono Film, Tin plate Container, Laminated Printed Pouch, Lined Carton
Glass Bottle Composite Container, Plastic Container
 Packaging of Ginger
Properties of Ginger
High moisture content
Irregular shapes and sizes
Aromatic spices
Odour and taste
Different Forms of Ginger:-
Dry Ginger
Ginger Power
Ginger oil
Ginger Paste
Ginger wine
Packaging of Ginger Powder
Material used for Packaging:-
PET Poly pouches
PET/ HDPE Containers
Lined carton
Packaging of Shellac
Shellac is a resin secreted by the female lac bug on trees in the
forests
It is processed and sold as dry flakes and dissolved in alcohol to
make liquid shellac
Packaging Material for Shellac Varnish :-
Metal Containers, Plastic Containers
Packaging Materials for Shellac Bangles:-
Duplex board carton, Composite containers
Creativity & Innovation
Program Objectives

 To understand the difference between creativity &

innovation.
 To understand how brain works
 To provide tools and techniques to bring in more
creativity in our work
 To practice the discussed tools and techniques and
develop an understanding & comfort to readily using
them at work

The program, aims at nurturing one of the four Leadership

Attitudes,
“EXPLORE” of E4 2
Topics

 Difference between creativity and innovation

 Mind mapping
 Reframing
 Assumption reversal
 Analogies and Metaphorical Thinking
 Discontinuity
 Brainstorming
 Discussion and possible barriers
 Putting it all together - Activity
What is creativity
What is innovation

5
Creativity vs Innovation

6
How our brain works?

Hare Brain Tortoise Mind

Divergent vs Convergent Thinking

Divergent Thinking

Convergent Thinking
Convergent Thinking
8
Assumption / Problem reversal

Here's an assumption that many businesses make: customers

want good service. But the assumption
reversal technique proposes that you turn that around: customers
don't want good service.

By questioning the seemingly obvious assumptions about a

problem, you can spark off new ideas for tackling it. Even the most
basic assumptions are up for analysis.

9
Analogies and Metaphorical Thinking

10
 Crisps were like leaves, and
then thought about how you
would pack leaves efficiently.
If you compress dried leaves,
they break. However, you can
press leaves so long as they are
moist and not dry.

This led the manufacturers to the

idea of mixing dried potato with
water and then pressing
it into shape, so the crisps could
be stacked and occupy less
space on the supermarket
shelves

11
 Brainstorming
The creative problem solving method
Why & When to use it
Benefits of Brainstorming
Mind Map
Mind mapping

17
Discontinuity

an approach which forces you out of the rut by introducing

untypical behavior or ideas

18
Force field technique
Putting it all together..
Presented By :
Partha Das Mohapatra
Deputy Director & Central Licensing Authority
FSSAI ,North Eastern Region
Turn of Mic ANSWER in CHAT BOX Put Doubts in Chat Box
 Content
1. Food Standards
2. National and International food standards and their role in
ensuring food quality and safety
• CAC (Codex Alimentarius Commission )
• International Organization for Standardization
• World Trade Organization
3. National Standards :FSSAI
• FSSAI Rules and Regulations
• Licensing and Registration System
• Standards of Forest Minor Produce
• Registration Procedure (NEW FOSCOS)
 STANDARDS

1. Company Standards: These are prepared by a Company for its own use.

Normally, they are copies of National Standards.

2. National Standards: These are issued by the national standards body.

3. Regional Standards: Regional groups with similar geographical, climate,

etc. have legislation standardisation bodies. ( Regional Code of Hygienic

Practice for Street-Vended Foods in Asia )

4. International Standards: The International Organisation for

Standardisation (ISO) and Codex Alimentarius Commission (CAC) publish

international standards.
International Organizations and Agreements in the Area of Food
Standards, Quality, Research and Trade

The major organisations which are playing a key role are:

1. Codex Alimentarius Commission (CAC)
2. International Organisation for Standardisation
3. World Trade Organisation
What is the Codex Alimentarius
Commission?
• A joint FAO/WHO inter-
governmental body with
188+1 member countries (as
of August 2005) plus 237
observers

• Responsible for implementing

FAO/WHO Joint Food
Standards Programme since
1962
 What is the function of the CAC?
• To protect the health of consumers
• To ensure fair practices in the food trade
• To coordinate food standards work
internationally
• To finalise and publish international
standards, codes of practice and
recommendations in the Codex
Alimentarius
 The Codex Alimentarius

• ‘Codex Alimentarius’ means ‘Food Code’

• Comprises 14 volumes
• All standards available at Codex web-site
• Codex standards are recommended (not mandated)
food quality and safety standards
 INTERNATIONAL ORGANISATION FOR STANDARDISATION

• The International Organisation for Standardisation (ISO) is a

worldwide, non-governmental federation of national
standards bodies (ISO member bodies).
• The work done by ISO results in international agreements
which are published as International Standards.
• ISO 9000 is an international reference for quality
requirements. It is concerned with “Quality Management” of
an organisation.
• Adoption of these standards is voluntary.
World Trade Organisation (WTO)
• WTO was established in 1995.
• The main objective of WTO is to help trade flow smoothly,
freely, fairly and predictably, by administering trade
agreements, settling trade disputes, assisting countries in
trade policy issues.
• In order to enforce adoption and implementation of
standards, there is a need for a strong Food Control System.
An effective food control system must consist of —
• (i) Food Inspection and
• (ii) Analytical capability.
 NATIONAL STANDARDS :
• PFA(Prevention of Food Adulteration Act
• Fruit and Vegetable Product Order
• Meat Food Products Order
• Milk and Milk Products Order

• BIS , AGMARK etc

FOOD SAFETY AND STANDARDS ACT 2006

•An Act to consolidate the laws relating to food and to establish
the Food Safety and Standards Authority of India for laying down
science based standards for articles of food and to regulate their
manufacture, storage, distribution, sale and import, to ensure
availability of safe and wholesome food for human consumption
and for matters connected therewith or incidental thereto.

•The Act came into force on 15th October 2007 .

FOOD SAFETY AND STANDARDS ACT 2006

Under Section 31 of the FSS Act 2006 , No Person shall commence or carry
on any Food Business except under the license

Food business” means any undertaking,

whether for profit or not and whether public
or private, carrying out any of the activities
related to any stage of manufacture,
processing, packaging, storage, transportation,
distribution of food,
import and includes food services, catering
services, sale of food or food ingredients
FOOD SAFETY AND STANDARDS REGULATIONS
FSS(Licensing and
Registration of Food
Businesses)Regulations
FSS(Food Products
,2011
Standards and Food
Additives)Regulations,
2011
FSS (Packaging &
Labelling ) Regulations
2011
FSS(Contaminants,
Toxins
FSS(IMPORT) Regulations ,Residues)Regulations,
2017 FSS(Organic 2011
)Regulations 2017
 Food Safety and Standards (Food Products Standards
and Food Additives) Regulations, 2011

•These regulations came into force on or after 5th August,

2011

•14 Broad Food Categories

•Forest Minor Produce Foods comes under these regulations

and under Food Safety and Standards (Health Supplements,
Nutraceuticals, Food for Special Dietary Use, Food for Special
Medical Purpose, Functional Food and Novel Food)
Regulations, 2016
Minor Forest Category Description
Produce
(a) “Arecanuts” or “Betelnuts” or
“Supari” means nuts obtained from
Areca Palm (Areca catechu L.).

b) The product shall be dry, well

matured, sound, clean, whole or cut,
Betel Nut Areca fully dehusked, uniform in colour, i.e.,
2.3.55
catechu bright shining to dull red colour.
(Dry)
c) It shall be free from synthetic
colouring matter and shall be free from
insect infestation, visible moulds,
fissures and shrinkage and shall not be
hollow.
 Minor FSSR Description (FSS CODEX
Forest Category Stanadards) DESCRIPTION
Produce
Rice shall be whole Rice is whole and
and broken kernels broken kernels
obtained from the obtained from the
species Oryza sativa species Oryza sativa L
L
Black Rice Quality factors –
and Johar Rice[06.1] (De- Husked) is general: Rice shall be
Rice obtained from paddy safe and suitable for
by removing husk human consumption.
and the process of Rice shall be free
de -husking and from abnormal
handling may result flavours, odours,
in some loss of bran living insects and
mites.
 Minor Category FSS Description Codex Description
Forest
Produce
Products in which the This standard contains
natural water content has general requirements
been reduced below that applicable to all edible fungi,
critical for growth of whether fresh or processed,
Microorganisms without permitted for sale by the
affecting the important competent authorities in the
nutrients. The product may consuming countries, except
or may not be intended canned cultivated
Dried fungi for rehydration prior to mushrooms of the genus
Mushroom consumption. Includes Agaricus.
[04.2.2.2]
vegetable powders that are Different requirements for
obtained from drying the the products covered by this
juice, such as tomato standard may be laid down
powder and beet powder in group of products
etc such as dried potato standards or in individual
flakes, dehydrated carrots or standards.
peas or cabbage or
mushroom or spinach leaf or
lentil etc.
 Minor Forest
Category Description
Produce
Mustard (Rai, Sarson) whole means the
dried, clean mature seeds of one or more
of the plants of Brassica alba. (L). Boiss
(Safed rai), Brassica compestris L.var,
dichotoma (Kali
Sarson), Brasssica Compestris, L. Var,
yellow Sarson, Syn, Brassica compestris L,
var glauca (Pili Sarson), Brassica,
12.2.1 Mustard compestris L. V ar. toria (Toria),
Mustard (Rai,
(Rai, Sarson) Barassicajuncea, (L). Coss et Czern (Rai,
Sarson) Lotni) and Brassica nigra (L); Koch
(Benarasi rai).

It shall be free from mould, living and

dead insects, insect fragments, rodent
contamination. The product shall be free
from the seeds of Argemone Maxicana L,
any other harmful substances and added
colouring matter.
 Minor Forest Category Description
Produce
Fruit from which water is
removed to prevent microbial
growth which includes dried
fruit leathers (fruit
rolls)prepared by drying fruit
purees. Such as cashew nut,
Cashew Nut 4.1.2.2 Dried
almond, raisins, dried apple
(Anacardiumoc fruits, nuts and
slices, figs, copra (dried coconut
cidentale) seeds
whole or cut), dried shredded or
flaked coconut, prunes,
dehydrated fruits
etc.
 Minor Forest Category as per
Description
Produce FSSR

Fruit from which water is removed to

prevent microbial growth which
includes dried fruit leathers (fruit
Dried Ginger rolls)prepared by drying fruit purees.
Ginger dry
(Sonth, Dried Such as cashew nut, almond, raisins,
(Zingiberofficinale)
Adrak)[12.2.1] dried apple slices,figs, copra (dried
coconut whole or cut), dried shredded
or flaked coconut, prunes, dehydrated
fruits etc.
Minor Forest Category as per FSSR Description
Produce
a. Rosella (Hibiscus
sabdariffa)
b. Zanthoxylum (seed Can be used as plant or
and bark), botanical ingredients
c. Jack fruit (Artocarpus Extracts of plant
heterophyllus seeds) botanicals 13 category Can be used as
d. KachriHarra nutraceutical ingredient
(Terminalia chebula)
e. KachriBaheda (Termi
nalia bellerica)
 Minor Forest Category as per Description
Produce FSSR
Honey 11.5 Honey
Honey shall be the natural
sweet substance produced
by honey bees from the
nectar of blossoms or from
secretions of plants, which
honey bees collect,
transform and store in
honey combs for ripening.

It shall possess pleasant

aroma, sweet flavour and
taste characteristic of
honey and free from any
additives

22
 State Licensing State Licenses and
Authority Monitoring
FSSAI

Municipalities
Registering Authority
,Panchayat/Local Body

Central Licensing
Authority
Registration : Turnover Less than INR 12 Lakh

State License :Turnover above INR12 lakh

upto 20 Cr ,capacity up to 2MT (Mfg)

Central License : Above INR 20 Cr , capacity >

2MT (Mfg) , Importers ,Exporters ,Proprietary
Products
 ▪ FoSCoS an online application system launched in 2020
▪ A pan India application for https//: foscos.fssai.gov.in
• REGISTRATION
• STATE LICENSE
• CENTRAL LICENSE
• Tracking of FBOS

Log in & Start a new Select KOB & File FORM A or Submission of
Creation of ID application Capacity B and Upload Fee and
Docs application

Process Flow for Filing application

Petty FBO Sign-In
• Petty FBOs are small business etc. who are encouraged to apply for registrations.
• Applicant turnover must be less than Rs. 12 Lacs per annum
• Petty FBOs can login using mobile no. or email ID with OTP validation. Such Users are not
mandatorily required to create login and remembering password. Login Screen for Petty
FBOs

Login using mobile

ID/ email ID

Select KOB
Process Flow

Submit Application and Fees

Receive Registration
27
 CENTRAL STATE REGISTRATION
1. Firm 1. Firm(Prop./partner/company) 1. Photo
(Prop./partner/company) 2. Photo ID & Address Proof 2. PhotoID
2. Photo ID & Address Proof 3. Proof of Premises (Electricity (Voter/Pan/Aadhar
3. Proof of Premises Bill /Lease/Rent Agreement , )
(Electricity Bill /Lease/Rent Sale Deed) 3. Address Proof
Agreement , Sale Deed) 4. Turnover Proof /Declaration or (Voter/Driving
4. Turnover Proof /Declaration Mfg Machinery List License etc)
or Mfg Machinery List 5. Recall Plan 4. Trade License
5. Product Details ,KOB details 6. Trade License/ NOC from 5. Form A
6. Recall Plan Panchayat
7. Trade License /NOC from 7. Product Details ,KOB details
Panchayat 8. FSMS , FORM IX FORM B ,
8. IEC for Import/Export General Declaration
9. FSMS , FORM IX FORM B ,
General Declaration
 FSSAI LICENSE /REGISTRATION NUMBER

14 Digit License / Registration Number is issued to

FBO which can be identified as follows :
2 1 7 2 0 0 0 2 0 0 8 1

License/ State/U.T Year Designated/ Serial Number of

Registration Registration Officer License/Registration
INDEPTH MANAGEMENT INDIA PRIVATE LIMITED
Innovations and solutions

Contact Details:
Manoj singh
[email protected]
+91-9650601103/9886074626
www.indepthmanagement.in
INDEPTH MANAGEMENT INDIA PRIVATE LIMITED

A Trusted Partner Providing

One Stop Solutions to Food Quality and
Safety
Through Innovations and Solutions !!

Registered office- A-7 Sai Ashish CHS, Sector-2, Airoli

Navi Mumbai, Thane, Maharashtra,
India- 400708.
 Innovations and solutions

What is Laboratory
Importance of Lab Accreditation
Concept of ISO/IEC 17025-2017 Management system
Laboratory Testing
Quick techniques
Data Analytics
Risk Based approach
Shelf life study
Farm to Fork approach
Food packaging
Analytical advancements
Sampling
Notified and referral labs
MANOJ SINGH
Auditor trainer and consultant

An Organic chemist by education from BHU Varanasi having industrial experience of over 25 years in
food ,water and chemical testing laboratories and industry.

He carries versatile and multifaceted experience in the field of Technical and system training, Quality
Assurance, Assessment – Product Certification, Laboratory setup and management, Quality
management, Laboratory accreditation and Vendor assessment A qualified assessor for ISO 17025
completed more than 500 maydays as technical and lead assessor
He is certified green belt in 6 sigma, a certified third party auditor for ISO 9001,14001,22000 and BRC
food.
He is a NBQP(QCI) approved consultant for laboratory management system and has successfully
completed consultancy and training for GLP,HACCP,PAS 96,22000,BRC food and Packaging, molecular
biology, RSPO and ISO 17025 for industry and laboratory.

He has been contributing to industry significantly as Technical/ Lead Assessor for National
Accreditation Board for Testing and Calibration Laboratories (NABL) and as Technical Expert for EIC
Laboratory approval. He has been associated with various organizations like FRAC New Delhi, SGS
India Pvt. Ltd., Gurgaon, ITC R&D Centre Bangalore and Intertek India in his past assignments as
head of Analytics and Testing for food services
Quality is generally considered as the degree of excellence.
In relation to seafood, quality is the sum total of its composition,
nutritive value, degree of freshness, physical damage and health
hazards

Quality control means all the steps taken between harvest and retail
trade to protect the quality of the final product.

The compliance is demonstrated through regular inspection and

testing

➢ To ensure that product has been prepared from quality raw material and it
never been grossly contaminated.
➢ To ensure that product is free from pathogens and toxins of public significance
➢ To ensure that product has reasonably extended shelf life
 Food safety culture

SSOP sanitation standard operating procedures

IPQC- In process Quality Control

TQM –Total Quality Management

Integrated organisational efforts designed to improve quality of

processes at all levels
Non-compliance of product are-
➢ 90% Microbiological
➢ 5% Chemical
➢ 5% Physical
Prevalence of pathogens-
➢ E Coli-25%,
➢ Salmonella- 18%,
➢ Vibrio P. -15%
➢ Listeria m.-2%

PREVENTING INCIDENTS IS VITAL TO SUCCESS

Samples Laboratory Results of
Processes Analysis

Good Laboratory Practices

6.3 Facilities and environmental conditions
6.3.3 The laboratory shall monitor, control and record environmental
conditions in accordance with relevant specifications, methods
or procedures or where they influence the validity of the results.

6.5 Metrological traceability

6.5.1 The laboratory shall establish and maintain metrological
traceability of its measurement results by means of a
documented unbroken chain of calibrations.

7.2.1 Selection and verification of methods

7.2.1.1 The laboratory shall use appropriate methods and subjected
to verification/validation.
4.11.8 Environmental monitoring
SOI Risk-based environmental monitoring programmes shall
be in place for pathogens or spoilage organisms. At a
minimum, these shall include all production areas with
open and ready-to-eat products.

• Sampling protocol.
• Identification of sample locations
• Frequency of tests
• Target organism(s) (e.g. pathogens, spoilage organisms and/or
indicator organisms)
• Test methods (e.g. settle plates, rapid testing and swabs)
❑ Appropriate control limits shall be defined for the
environmental monitoring programme.
❑ The company shall review the environmental monitoring
❑ The positive results
❑ Consistent negative results
❑ All product and group must be tested once in year
❑ Storage and shelf life leading to retesting
 Certification is a  Accreditation is the formal
declaration by a neutral third
comprehensive evaluation of party that the certification
a process, system, product, program is administered in a
event, or skill typically way that meets the relevant
norms or standards of
measured against some certification program
existing norm or standard.  Uses criteria specifically
 Certification does not make developed to determine
technical competence of
any statement about the the laboratory.
technical competence of  This is an independent
the laboratory. evaluation of laboratory’s
 Example ISO 9001:2005 technical competence
Certification  Accreditation-Example ISO
17025

CERTIFICATION ACCREDITATION
15
16
17
 Application for Accreditation
(by Laboratory)

Acknowledgement & Scrutiny of Application

(by NABL Secretariat) Feedback to
Laboratory
Adequacy of Quality Manual
(by Lead Assessor)
and
Pre-Assessment of Laboratory
(by Lead Assessor)
Necessary
Final Assessment of Laboratory Corrective
(by Assessment Team)
Action
Scrutiny of Assessment Report by
(by NABL Secretariat) Laboratory
Recommendations for Accreditation
(by Accreditation Committee)

Approval forAccreditation
(( by Chairman NABL) www.nabl-india.org
18
Issue of Accreditation Certificate
(by NABLSecretariat)
INPUT
LABORATORY

DATA

DECISION

HEALTH ,SAFETY
ENVIRONMENT
➢Traceability

➢Reference Material

➢Test Methods

➢Proficiency Testing

➢Measurement Uncertainty
• In evaluating the competence of a laboratory, the following methods are used:

• On –the-spot assessment of the laboratory by the experts .

• By evaluating the results of a particular test/measurement in a proficiency testing

programme.
• WTO;
• Technical Barriers
• Evaluations are based on;
• APLAC MR 001 requirements
• International teams of trained evaluators
• Possible pre-evaluation
• Documentation review (two days):
• ISO/IEC 17011 compliance of management system
• Accreditation criteria consistent with ISO/IEC 17025
• Independence and authority
• National accreditation body can be a statutory body
• May be established by Act of Parliament
• User and/or government funded, "not for profit"
organization
• And has to be a third-party accreditation body
Internationally recognized through MRAs
• National and international recognition Public and industry acceptance
• Assurance to clients on validity of results Provides global equivalence
• Provides comparability in measurements Decision makers can rely on test results
Improves staff motivation
• Ensures better support in the event of legal challenge
• Saves money by getting it right at first time
▪ Taking the attendance of employees by punching cards, is a system.

▪ Recording of the measurement data in log-sheet is a system.

 Lab Quality
Manual

Procedures

Work Instruction/SOP/ test

standards/Test Methods/other
documents

Forms/Records

Recor Personnel & Trg.

Sample purchasing Sampling Testing d Dispatch
receipt preparati
on
 8. Management System
4. General 5. Structural 6. Resource 7. Process Requirements
Requirements Requirements Requirements Requirements

8.1 Options
4.1 7.1 Review of 7.2 Selection, verification
Impartiality 6.1 General requests, and validation of methods A/B
tenders &
contracts 8.2 Management 8.3 Control of
7.4 Handling of system management
4.2 6.2 Personnel test or calibration documentation system documents
Confidentiality 7.3 Sampling items

6.3 Facilities & 8.5 Actions to

3 environmental 7.6 Evaluation 8.4 Control of address risks and
7.5 Technical records (Option opportunities
Terms & conditions records
of MU
A)
Definitions
6.4 Equipment 8.6 8.7
2 7.7 Assuring the 7.8 Reporting of Improvement Corrective
Normative validity of results results action
References 6.5 Metrological
traceability 8.8 Internal 8.9 Management
7.9 Complaints 7.10 Non audits reviews
conforming
1 work
6.6 Externally
Scope provided 7.11 Control
products and of data –
Information
services
management
2
8
Conventional Microbiology Quick techniques
Conventional RT-PCR –DNA Test
➢ Selective media, growth time
and Biochemical identification
then confirmation
➢ Technical competency and
subjective Specific DNA micro-biological
➢ 2-7 days for initial and 7-10 days species
for final results Detection and confirmation in
real time
Automated, easy and objective
2 hours for indicator One day
for pathogen reporting
Magnetic Bead based Extraction Chemistry

Spin Column based Extraction Chemistry

❑ Qualitative & Quantitative Analysis
❑ Food Pathogen Identification
❑ GMO screening & Testing
❑ Food Allergen testing
❑ Animal species Identification for Meat
❑ Species Identification in Dairy and Dairy related products
❑ Halal & Koescher
❑ Disease Diagnostics such as White and yellow spot, Brucella etc.
➢ Enzyme-linked immunosorbent assay (ELISA), also known as an enzyme immunoassay (EIA),
is a biochemical technique used mainly in immunology to detect the presence of an antibody
or an antigen in a sample.

➢ The ELISA has been used as a diagnostic tool in medicine and plant pathology, as well as a
quality-control check in various industries, such as ELISA application in food industry.

➢ In simple terms, in ELISA, an unknown amount of antigen is affixed to a surface, and then a
specific antibody is applied over the surface so that it can bind to the antigen.

➢ This antibody is linked to an enzyme, and in the final step a substance is added that the
enzyme can convert to some detectable signal, most commonly a colour change in a
chemical substrate.
Indirect ELISA Direct ELISA

ELISpot

Competitive ELISA sandwich ELISA

 Standardized- methods

Verification

Modified standardized and in-house method

Validation
 MAN MONEY

5M

METHOD MACHINE MATRIX

IQ,OQ & PQ Acceptance
Quality control criteria & IQC
checks

System suitability test

Method validation

Instrument Qualification
False positive/False negative

Discrimination depends on method use

 Validation

Development Optimization
➢ Use of reference materials or quality control materials
➢ Use of alternative instrumentation that has been calibrated to
provide traceable results
➢ Use of check or working standards with control charts, where
applicable
➢ Intermediate checks on measuring equipment
➢ Replicate tests or calibrations using the same or different
methods
➢ Retesting or recalibration of retained items
➢ Review of reported results
➢ Intra-laboratory comparisons(Round robin test)
➢ Proficiency testing
 Data

Manual

Information

(Looking back (Looking forward

What happened?) What will happen?)
The normal probability distribution is by far the most common and
most important continuous probability distribution.
The normal curve is symmetrical and, because of its appearance, it
is sometimes called a ‘bell-shaped’ curve. Coverage factor: 95 % :
Factor = 2
• Random error: variation in QC results with no
pattern- only a cause for rejection if outside
2SDs.
• Systematic error: not acceptable, correct the
source of error
Examples:
– Shift–control on one side of the mean 6 consecutive
days
– Trend–control moving in one direction– heading
toward an “out of control” value
196.5 +3SD

194.5 +2SD
192.5 +1SD
190.5 MEAN

188.5 -1SD

186.5 -2SD
184.6
-3SD

Days
196.5 +3SD

194.5 +2SD
192.5 +1SD
190.5 MEAN

188.5 -1SD

186.5 -2SD
184.6
-3SD

Days
Statement of conformity –Refer clause 8.6.1 as per ISO
17025-2017
Based on the customer risk evaluation the basis of
compliance/non-compliance need to be communicated to
customer and agreed.
The definition of acceptance, rejection zones and guard band
assuming a probability of type of error ie PFA(Probability of false
acceptance or PFR(Probability of false rejection)

Decision Rule
50
Decision rule: a documented rule that describes how measurement
uncertainty will be allocated with regard to accepting or rejecting a
product according to its specification and the result of a measurement.

Acceptance zone: the set of values of a characteristic, for a specified

measurement process and decision rule, that results in product
acceptance when a measurement result is within this zone.

Rejection zone: the set of values of a characteristic, for a specified

measurement process and decision rule, that will give noncompliance
when a measurement result is within this zone.

Guard band: the magnitude of the offset from the specification limit to
the acceptance or rejection zone boundary.
Figure 3a) – Example of areas defined for a tolerance interval in order to minimise the consumer’s risk
Legend: TU – Tolerance upper limit ; GU –Acceptance zone upper limit ; TL – Tolerance lower limit ;
GL –Acceptance zone lower limit; U(y) – expanded uncertainty of the measurement.

Figure 3b) – Example of areas for the tolerance interval in order to minimise the supplier’s risk

52
 Harvest/Procurment

Customer

Packaging Regulatory
storage compliance
HOW TO ENSURE FOOD QUALITY AND SAFETY IN THIS COMPLEXITY

54
▪Good quality does not necessarily mean High quality.
▪ It means "a predictable degree of uniformity and dependability, at low
cost, with quality suited to market”.

What is Food Safety?

▪ Food Safety is a scientific discipline describing preparation, storage, and

handling of food in ways that prevent food borne illness

▪ Food Borne Illness is an illness carried or transmitted to people by food

56
 57
Drug
residues
◼ Everyday the World food industry is faced with new
problems, food scares, poisoning, product recalls, litigation

These events effect public perception and cause retailers,

insurers, shareholders and regulators to react accordingly.

◼ These reactions have consequences that pass down the

food supply chain.

◼ Events that change our future for ever.

58
▪ Customers (Consumer Preferences)
▪ Regulatory Bodies (Governments)
▪ World Health Organization (CODEX)
▪ Market Access (EC/USFDA )
▪ Shareholders, Insurers (Litigation/Claims)
▪ Retailers & Private Labels (Brand Protection)

59
 Offences

▪ Causing food to be injurious

▪ Abstracting any constituent
▪ Deliberate adulteration
▪ Nonconformance in label information etc-

60
 The Food Industry is experiencing many new paradigm shifts.
These are about changing rules & regulations relating to:

▪ Food Safety

▪ Quality

▪ Regulatory

▪ Market Requirements

61
 • To consolidate multiple laws and establish
1 single point reference system

• To establish Food Safety and Standards

2 Authority

• To regulate the manufacture, storage,

3 distribution, sale and import of food products

• To ensure availability of safe and wholesome

4 food for human consumption
62
 Zone 1
Product Contact Surfaces
(fillers, hoppers, screens, conveyer belts, air blowers,
employee hands)
Zone 2
Non-Product Contact Surfaces
(framework, refrigeration units, equipment housing)
Zone 3
(air return covers, phones, hand trucks, forklifts, drains)

Zone 4
(locker rooms, cafeteria, hallways, loading dock, maintenance
areas)
A function of the probability of an adverse health effect and the
severity of that effect, consequential to a hazard(s) in food.

The severity of its consequences if it does

The likelihood that a hazardwill affect us
Sampling and Sample collection
➢ Use of reference materials or quality control materials
➢ Use of alternative instrumentation that has been calibrated to
provide traceable results
➢ Use of check or working standards with control charts, where
applicable
➢ Intermediate checks on measuring equipment
➢ Replicate tests or calibrations using the same or different
methods
➢ Retesting or recalibration of retained items
➢ Review of reported results
➢ Intra-laboratory comparisons(Round robin test)
➢ Proficiency testing
The Shelf life

Shelf life and food safety

Factors affecting shelf life

Steps in shelf life determination

Shelf life and regulation

Perishable food is unprocessed or processed food that has a short shelf life at room temperature before
showing signs of deterioration or spoilage (often mould or bacterial growth seen as fur or slime), e.g.
fruit or pre-packaged bread.

Shelf life is the period of time, established under intended conditions of distribution, storage, retail and
use, that the food would remain safe and suitable.

Shelf life testing requires foods to be stored under the expected conditions of storage and distribution
for a period of time to determine at what point chemical changes, deterioration and/or spoilage of the
food occurs.

Shelf-stable food is food of a type that, because of its composition (low moisture, high salt or sugar
content) does not require to be refrigerated for storage or a food which would normally be stored
refrigerated but which has been processed so that it can be safely stored in a sealed container at room
temperature for a usefully long shelf life.
The stated shelf life of a food is the period of time for which it remains safe and suitable for consumption,
provided the food has been stored in accordance with any stated storage conditions. This means that the
food:

Must remain safe to consume, i.e. should not cause food-poisoning because of the growth of pathogenic
bacteria or the production of toxins (bacterial and fungal) in the food during storage;

Has not deteriorated in quality or spoiled in any way that the consumer would find unacceptable; and
has not lost significant amounts of any nutrients listed on the label.
There are many factors that may affect the shelf life of a product. Some factors
relate to the food itself (intrinsic factors), such as moisture and pH, while others
are external to the product (extrinsic factors), e g. the packaging conditions,
materials and storage conditions.

Setting up the study

subjective sensory testing, e.g. colour and textural changes, smell and taste; or
– objective laboratory tests, e.g. numbers of spoilage bacteria or yeasts appearance of mould growth,
presence of a chemical indicator of deterioration, such as D-alanine in fruit juice, rancidity, histamine in
seafood, etc.

The study should be repeated with several (at least three) batches of product to identify variability within
and between batchers. If there is a large variability within and/or between batches you will need to work out
how to reduce the variability.
How the product is made;

The composition of the food;

The type of packaging;

The hygiene of the processing environment; and/or

The quality of the ingredients

• Confidence in having an actual calculated
shelf life and not just an estimate
• Prevent recalls
• Maintain quality
• Protect brand/reputation
• Improve profitability
• Avoid expensive litigation
• Consumer safety
• New product launch
• Package re-design/New packaging
• Challenge the lifespan
• Collect data for validation
• Change in ingredients
• Change in supplier materials
• As part of your QA/QC Program
• Is your current package still performing?
 Farming Primary Retail/food
Global Farming processing Manufacturing Wholesale
Supply Chain service

BRC-PKG,
BRC-Food “one brand”
GobalGAP,
BRC-PKG IFS, “one brand” certification
SQF1000,
Auditing GMP+ FS22000 certification Supply chain
AG 9000
From Farm

Systems SQF2000, inspections

To Fork
GMP+

Auditing Management standards: HACCP, ISO 9000, 14000, 22000 OHAS 18001, 4500
Processes

Testing & Analytics

Lab Services

Product standards: Organic, non-GMO, Halal, Q&S, etc.

Advisory Advisory Services: Training, traceability, risk management, etc.

Services
 Research and
Development

Consumer Raw Materials Sourcing

Management

InDepth Total Quality

Assurance (Assurance,
Testing, Inspection and
Certification)
Distribution and Retail Component Suppliers
Channels

Transportation Manufacturing

Systemic Approach to Quality and Safety with ATIC Solutions

• Growth of food industry in
direct relation with global
growth of population

industrialized

R&D

Food
Quality

Food Safety

Food as nutrition • Fast growing need for food from

underdeveloped developing countries and emerging
nations
✓Wide choice of food products
✓Huge volume of different product and
testing marks
✓Rising health ‘trend’ through all
population
✓Information ‘jungle’ overloads
consumers
✓Consumers in EU, Japan, etc.: do not
accept GMO-Food (75 - 80%)
✓Consumers do not accept food
scandals and crises - want to have
safe food
✓Asking for neutral monitoring and control
mechanism
→ Consumer does require more information
on food products and the supply chain
 Inspection
•Security
•Social ”One stop solution”
Accountability Program
•Supplier Management
Assessment
 Identify
strengths and
weaknesses
How do you
implement it?

Planned activities

Review Implement
effectiveness activities
 •Antibiotic drug residues
Environmental
Processed & Packaged •Growth boosters
Contaminants;
Food Products, Irradiated • Microbes
Foods • DIOXINS

•Process byproducts
•Leaching from ctc surfaces, Sanitizers Animal
•Contamination during Storage & Handling Origin
•Package Migration
•Preservatives

Human •Poultry
FOOD
•Bovine
•Meat
•Sea Food
•Pork…………..et
GM Foods c

Water
 Environmental •Pest infestations
•Adulterants
Agricultural residues; Contaminants;
•Contaminants
• Microbes
Insecticides, Herbicides
Processed & Packaged
Food Products, Irradiated
Foods
NOTS
•Process byproducts
•Leaching from ctc surfaces, Sanitizers
•Contamination during Storage & Handling
Vegetarian Origin •Package Migration
•Preservatives

•Fruits & Vegetables

Human
•Cereals
FOOD
•Pulses
•Spices
•Mushrooms
•Others (Additives etc)

GM Foods

Water
HACCP
BRC
FSSC 22000
IFS
SQF 1000 & SQF 2000
ISO 22000:2005
ORGANIC
Global GAP
SUPPLIER DRIVEN STANDARDS
SA ,EMS,QMS

84
Selection of the sample material
The determination of migration is carried out on the material or article.

The sample shall be placed in contact with the foodstuff or simulant in a

manner representing the contact conditions in actual use.

Regulation EU 10/2011.

May analyse foods directly (complex matrix; analysis is challenging).

Simulants represent major food – Phys/Chem properties.

Food Simulant Abbreviation Type of Foods
Ethanol 10% Food Simulant A Hydrophillic
Acetic Acid 3% Food Simulant B Hydrophillic, with pH< 4.5
Ethanol 20% Food Simulant C Hydrophillic, Alcoholic, lipophilic
Ethanol 50% Food Simulant D1 Lipophilic, > 20% Alcohol, Oil in water
Vegetable Oil Food Simulant D2 Foods with free fat at surface
Tenax Food Simulant E Dry Foods

• For OML combination of simulants is indicated.

• For plastics OML = 10 mg/dm2 or OML = 60 mg/kg food.
• Specific migration limits for many individual components e.g. monomers
• Aromatic amines must be Not Detectable (LOD 0.01 mg/kg)
Global Migration (GM):
The overall migration limit is a measure of the inertness of the
material and prevents an unacceptable change in the
composition of the foodstuffs.
Specific Migration (SML):
Specific migration limit in food or in food simulant for
monomers and additives of the plastic directive.
Maximum permitted quantity in the polymer (QM):
Maximum permitted quantity of the ‘residual’ substance in the
material or article (e.g. Cadmium)
Packaging is used to protect food and keep it hygienic.
It is used to advertise the product and give information.
Too much packaging is wasteful and bad for the
environment.
We should try to recycle packaging when we can.
Plastic which breaks down when it is buried is called
biodegradable.
Packaging can be made of glass, plastic, card, steel or
aluminium.
“Protect your brands and reputation
with better agricultural and food
supply chain management,
from farm to fork”
 • Nutritional & Proximate analysis
1

• Toxic Contaminants
2

• Microbiological
3
Pesticides Residues / Antibiotics & Drugs Heavy Metals Residues:
NOTS/ VOC’s: Residues/ Mycotoxins/
Dyes/ Pesticides:
• Antibiotics & Drugs- Tetracyclines,
• Lead
• OC Pesticides • Cadmium
Sulfonamides, Nitrofurans,
• OP Pesticides Chloramphenicol, Streptomycin, • Arsenic
• Synthetic Pyrethroids • Aflatoxin B1, B2, G1, G2, M1
• Insecticides/ Fungicides • Mercury
• Ochratoxin, DON, ZEA
• NOTS: Saffrole • Chromium
• Sudan Dyes, MG, LMG
• THM • Pesticides & Insecticides • Copper
• VOC’s • Carbamates • Zinc
• NOTS: Hypericine, Agaric Acid • Tin
• Nickel
GC GCMS (Gas GCMS/MS GC-HRMS
(Gas Chromatograph Triple Quad
GC-TOF
(High Resolution
Chromatograph) with Mass Mass (Time of Mass Spectrometer)
Spectrometer) Spectrometer
Ion Trap or Single Flight)
Quad

ppm
ppm (ug/kg) ppt level with high Mass
(mg/kg) ppb (ug/kg)
with mass with high mass Resolution for ppt
With MRM
Confirmation resolution, best for level Quantification
unknown
Identification
HPLC LCMS/MS UPLC (Ultra UPLCMS/ EA/ LC-IRMS
(High Performance Triple Quad Fast Liquid MS (Isotope Ratio Mass
Liquid Mass Chromatograph) (UPLC with QQQ Spectrometer)
Chromatograph) Spectrometry Mass
With PDA, RI, Spectrometer)
Fluorescence detectors

ppm
ppb (ug/kg) ppm to ppb ppt level Elemental Analyzer
(mg/kg)
with SRM (ug/kg) and LC with Isotope
With shorter Better peak resolution, Ratio confirmation
runtime and shorter run time and ppt and Quantification
better resolution level of quantification and
High throughput
 Heavy Metal Residues
•Lead
•Cadmium
•Arsenic
•Mercury
•Chromium
•Copper
•Zinc
•Tin
•Nickel

UV/VIS Atomic Absorption AAS with (Inductively Coupled

Spectrophotom Spectrophotometer Graphite Plasma Mass
eter (AAS) Furnace Spectrometer (ICP-
% to ppm ppm ppb MS)
ppb to ppt (ng/kg)
(mg/kg) (mg/kg) (ug/kg) level of
quantification with
mass confirmation
 QuEChERS:
Quick, Easy, Cheap, Effective,
Rugged, and Safe, the QuEChERS
(“catchers”)

Solid Phase
Extraction QuEChERS was developed using an
Liquid-liquid extraction: (SPE) extraction method for pesticides in
fruits and vegetables, coupled with a
cleanup method that removes
Traditional methods for sugars, lipids, organic acids, sterols,
proteins, pigments, and excess
sample prep for pestcides
water. This technique offers a user-
residues in food & friendly alternative to traditional
agricultural products liquid-liquid and solid phase
extractions.

• European EN 15662 Method

• AOAC Official 2007.01 Method
 Solid Phase Extraction
(SPE):

“Retention-Cleanup-Elution
Strategy”

Liquid-liquid Extraction/
Liquid-solid Extraction: As the sample is loaded onto the
cartridge, the analytes of interest
are retained by the sorbent.
Traditional methods for sample If needed, an optimized series of washes
prep for Antibiotics & Drugs are used to remove matrix interference
residues in food & agricultural from the cartridge.
products A strong solvent is used to elute the
analytes from the cartridge.
Sample enrichment results when the final
elution volume is smaller than the load
volume.
98
• ‘lot’ means an identifiable quantity of a food commodity delivered
at one time and determined by the official to have common
characteristics, such as origin, variety, type of packing, packer,
consignor or markings.
• ‘sublot’ means a designated part of a large lot in order to apply
the sampling method on that designated part; each sublot must
be physically separate and identifiable;
• ‘incremental sample’ means a quantity of material taken from a
single place in the lot or sublot
• ‘aggregate sample’ means the combined total of all the
incremental samples taken from the lot or sublot
• ‘laboratory sample’ means a sample intended for the laboratory
100
✓ Each lot/sub-lot must be sampled separately
✓When there are two or more consignments in one “ship” or
container, each consignment must be sampled separately
even if the product is identical (i.e groundnuts both).

– Lots are sampled according the size

– Number of primary samples depends on the size of the lot
–Each primary sample should be taken from a randomly
chosen position in the lot
– Primary samples should be combined and mixed well to
form the aggregate sample

101
▪ Minimum size of the laboratory sample
depends on the contaminant and on the
product
▪ Sampling must be recorded properly
▪ Samples should be sealed and labelled
▪ Should be sent to the laboratory as soon as
possible

102
➢ Sampling shall be performed by an authorized person.
➢ Each lot which is to be examined shall be sampled
separately
➢ Large lots shall be subdivided into sub-lots to be
sampled separately
➢ The sampling apparatus must be made of materials
which cannot contaminate the products to be sampled.
➢ Sampler should follow safety.

103
FSSAI Notified NABL Accredited Food Testing Laboratories vide
notifications number (E) dated 13th February, 2020 and File No.
12012/01/2019-QA dated 23rd July, 2020 for the purpose of carrying out
Analysis of Samples taken under Section 47 of the Food Safety and
Standards Act, 2006.
Total labs -188

188
Innovations and solutions
 Innovations and solutions

www.indepthmanagment.in
[email protected]
9650601103,9886074626
107
Processing and Value Addition of Mushroom

Dr. Dayaram
Project Director
ADVANCE CENTRE OF MUSHROOM RESEARCH
 CHALLENGES

• Unemployment
• Land division (shrinking cultivated land)
• Climatic change
• Crop residue burning
• Migration
• Removal of rural poverty
• Malnutrition
• Water shortage
 OPPUTURNITIES

• Temperature ranges (10-38 0C)

• Huge amount of crop residue
• Higher density of population
 CHALLENGE DELIBERATION

•
Kheti Bina Khet Ke/ Vertical farming
•
Short duration crop
•
Crops under different temperature regime
Temperature:
Minimum 10 oC
Maximum 38 oC
CULTIVATED VARIETY
 ENTREPRENEURSHIP POTENTIALITY OF
MUSHROOM

Spawn Compost Round the year

Mushroom Product
Production Production Cultivation Development

Marketing
 EFFICIENT USE OF AGRO
h ro o m WASTES
u s
M

M
Grains
come Generation

ilk
Kitchen Garding

Myco straw

n g
Trad. Compost D u

ermicompost
Qualitycompost
 POST HARVEST MANAGEMENT TECHNOLOGY

HARVESTING OF CROPS

Oyster Mushroom
Contd….

Milky Mushroom

Paddy Straw Mushroom

Contd….

Hericium Mushroom

Shiitake Mushroom
Contd….

Clining and Grading : Standard size mushroom should be

separated
Packaging : Poly Packaging
Marketing and
Transportation : Ice packing for long distance and
marketing
 READY TO COOK

Ø
Dehydration: Oyster and milky mushroom at 65°C.
Button mushroom can be dehydrated by
cryogenic dehydration.
Ø
Powder
Ø
Laddo
Ø
Pakauda
Ø
Cutlet
Ø
Chaup
Ø
Kheer
Ø
Contd….

Mushroom Pakauda

Mushroom Cutlet
Contd….

Mushroom Litti

Mushroom Gujhiya
Contd….

Mushroom Chaup

Mushroom Halwa
 READY TO EAT

Mushroom Powder

Mushroom Laddu
Contd….

Mushroom Bhujia

Mushroom Samosa
Contd….

Mushroom Namkeen

Mushroom Saus
BRANDING OF VALUE ADDED
PRODUCTS
Thank
s