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1. Total Quality management ( TQM)

2. ISO 9000
3. ISO 14000
4. Difference between QA and QC as
5. Explain Recall and different types of Recalls
6. Explain Complaints/ Complaints Handling system
7. Analytical validation
8. Quality control & Quality Assurance as per GMP
9. QBD ( Quality By Design)
10. Diff between Validation and Calibration
11. Good warehousing practices ( GWP)
12. ICH Guidelines & QSEM
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13. NABL ( Accreditation)
14. GLP ( Good laboratory practices)
15. Validation master plan & validation protocols
16. Calibration of pH meter
17. Qualification of UV visible Spectrometer
18. Personal training

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19. Personal Hygiene
20. Personal responsibility
21. Quality control for 1° , 2° , 3° Packaging
22. Quality reviews
23. Sterile areas ( environmental & contamination
control ) (Aseptic Area)
24. Plant layout
25. Quality control test for Closures
26. Equipment Selection
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27. Raw materials
28. Difference between calibration & validation
29. Master formula record
30. Quality Audits
31. SOP ( standard operating procedure)
32. Design and construction
33. Document and records

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Q. 1 ) Explains Total Quality • Highly sensitive products handle in
separate production areas.
management (TQM) • protect production form
Ans:- contamination
I) Total Quality Management 2) Storage
• Total Quality Management is defined • store product in air tights containers
as a customer-oriented process and • storage area must be clean
aims for continuous improvement of • storage materials should be best
business operations. quality
• common goals of TQM is 3) Packaging
- Improve product quality • packaging processes should be
- Improve service quality defined and controlled
- Improve production process • ensure that correct materials are
- Improve manufacturing packed
process • labels should be durable
- Improve process of rendering
• labels must provide correct
of services.
information
II) Advantages of TQM
4) Facilities and Equipment
1) Improves reputation, faults
• The location, design, and
and problems
construction of buildings should be
2) Higher qualified employees
suitable for manufacturing
3) Lower cost
• Equipment should be clean and
4) Decrease waste
5) Sterile area
5) Fewer defective products
• the sterile area was free form
6) Quality control inspector
contamination
III) Disadvantages Of TQM
• Smoking, eating, drinking, avoid in
• Initial introduction cost
Production areas
• Benefit may not be seen for
6) Labelling
several years
• label should be clean clear and
• Workers may be resistant to
durable
change
• label should contain sufficient
IV) Importance of TQM in Pharma
information
Industry
7) Computerised System
1) Handling
• Computer systems should be
• open the container carefully
designed To store data
• open container by approved manner
• A back-up system should be
provided of all quality critical data.
V) Elements Of TQM
5) Corrective action for root cause:
1) Management Commitments to • TQM aims at preventing repetition
Quality of problems by identifying the root
• Top management should continue causes for their occurrence and
all the efforts and provide the developing means and corrective
resources to continue quality actions to solve the problems of the
improvement Programmes root level

2) Customer Satisfaction 6) Training

• TQM is designed in such a manner • Proper train ng programmes have to
so as to meet the expectations of be undertaken to train the
customers. employees for the use of TQM
• It must be recognized that concepts and techniques.
customers are the most important • Employees have to be provided
persons for any business. regular training for continuous
• In the present era, customer is the improvement.
king , so Customer Satisfaction is
important 7) Recognition of high quality
• TQM aims at developing long term
3) Measurement of quality relationships with a few high quality
• Quality is a measurable entity and suppliers rather than those suppliers
we must know what current quality who supply the inferior goods at the
levels are i.e. where we are or where low cost.
we stand in respect of the quality .
8) Involvement of employees
4) Continuous improvement: • Involvement of employees means
• TQM comprises of a continuous that every employee is completely
process of improvement covering involved at every step of production
people, equipment, suppliers, process which plays an active role in
materials and procedures. It includes helping the organization to meet its
every aspect of an operation in an targets. Employee involvement and
organization. empowerment can be assured by
enlarging
Q. 2) Write Note on ISO 4) Document and Data control
• To establish and maintain document
9000 procedures to control all documents
Ans:- and Data as standard

I) ISO 9000 5) Design control

• To establish and maintain
• ISO 9000 is a set of internationally documented procedures to control
recognized standards for quality and verify the design of the product
assurance and management to ensure conformance to specified
requirements.
II) Purpose of ISO 9000
6) Control of customer supplied
• To sell in the European Union product
market • To establish and maintain
• To compete in domestic markets documented procedures for the
• To improve the quality system control of verification storage and
• To improve subcontractors’ maintenance of customer-supplied
performance product provided, for incorporation
into the supplies or for related
III) Elements Of ISO 9000 activities.

1) Management responsibility 7) Product identification and

• To define, document, implement a traceability:
policy for quality. • Where appropriate, to establish and
maintain documented procedures
2) Quality system: for identifying the product from
• To establish, document, and receipt and during all stages of
maintain a quality system which production, delivery and installation.
includes a quality manual, system
procedures, and quality planning. 8) Process control
• To identify and plan the production,
3) Contract review: installation and servicing processes
• To establish and maintain which directly affect quality, and to
documented procedures for ensure these processes are carried
contract review. out under controlled conditions.

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 9) Inspection and testing
IV) Benefit of ISO 9000
• To establish and maintain
• ISO 9000 continues work on
documented procedures for
improvement
inspection and testing activities to
- Improve control
in order to verify that the specified
- Improve discipline
requirements for the product are
- Improve procedure
met.
- Improve Documentation
- Customer satisfaction
10) Control of inspection,
• Reduction in error and customer
measuring and test equipment
complaints
• better working environment
• To establish and maintain • Reduce audits
documented procedures to control, • Enhance marketing
calibrate and maintain inspection, • Improve employee motivation
measuring and test equipment • Promote international trade
used by the supplier to • Increase profit
demonstrate the conformance of
• Reduce waste and increase
product to the specified
production.
requirements.
V) Disadvantages Of ISO 9000
11) Control of non conforming
product
• Not all countries accept ISO
• To establish and maintain registrars
documented procedures to ensure • ▪ Mainly for exporting firms
that product that does not conform • Barrier to trade
to specified requirements is • Time consuming
prevented from unintended use or • Costly
installation. • Difficult for small firms to afford
12)Handling, storage, packaging,
preservation and delivery
• To Establish and maintain
documented procedures to prevent
damage or deterioration of product.
Q. 3) Write Note on ISO
V) Importance Of ISO 14000
14000
Ans:- • Reduces environmental liability
• Enhances public image and
I) ISO 14000 reputation
• Assures customers
• Satisfies investor criteria
• ISO 14000 is a family of standards
• Reduces the cost
related to environment
• Improve industry-government
management that exists to help
relations
organizations.
VI) Elements Of ISO 14000
II) Features
1) Environmental policy
• better environment management
• flexible and applicable to all nations
• scientific • Clearly outline the environmental
• practice and useful policy.
• This is a clearly written statement
III) Object outlining a business's objectives and
• Minimize operations which harm to targets, in the context of their
environment environmental policy.
• comply with applicable laws and • Policy should always be clearly
regulation communicated both internally and
• Continue improve in the above externally, as well as fully
implemented.
IV) ISO 14000 Entails five aspects
I) Environmental Management 2) Planning
System
II) Environmental Auditing and • Make complete, thorough plans for
related investigations implementing the EMS.
III) Environmental Labels and • With clear, thorough planning,
Declarations organizations stand to assess the
IV) Environmental Performance environmental impact of all
Evaluation operations.
V) Life Cycle Analysis & Terms and
Definitions
 3) Implementation VI) Benefits Of ISO 14000
• After planning, this step involves the
execution of those plans • Cost savings in waste, recycling and
• This step will also incorporate consumption
adjustments and even building of
new processes to adapt to changing • Advantage over competitors when
requirements. tendering for business
• Scope of this section also includes
emergency response planning and • Management of environmental risks
preparedness.
• Compliance with individual
4) Study and correct countries environmental regulations
• After implementing the most basic
EMS, observe how it functions, and • Demonstrates your commitment to
make corrections or optimizations improving the environment
as needed.
• This step involves the management • Shows you are a responsible future
of new and existing procedures to focused organization
make sure KPIs are hit and that the
EMS is functioning as it should be. • Can reduce insurance cover costs

5) Management review • Can increase employee engagement

• This could really tie in with the in the knowledge that they are
previous section, but it's important working in an environmentally
to have a distinguished review of friendly organization.
the EMS conducted by
management, to make sure that
everything is functioning within the
scope of successful performance.

6) Continuous improvement

• Every EMS will utilize principles of

continuous improvement to enable
organizations to optimize all aspects
of the system.
Q. 4) Difference Between QA & QC (Quality Assurance &
Quality Control)
Ans:-

QA QC

1) It is a Managerial Tool and 1) It is a Corrective Tool and Lab

Company based. based.

2) It is a wide-ranging concept. 2) It is a small part of quality

assurance.

3) It is responsible for each 3) Its responsibility is limited to

activity which is directly or sampling and testing of materials.
indirectly affects the quality of the
product.

4) It has superior authorities in 4) Its authorities are limited to its

the pharmaceutical department i.e. QC.
manufacturing plant.

5) They are answerable for each 5) They are activities answerable

activity in the manufacturing for in the QC department only.
plant.

6) They have master control of 6) No such authority.

each document.
Q. 5) Explain Recall and different types of Recalls
Ans:-
• There are three types of recalls are as follows
1) Class I Recall

2) Class II Recall

3) Class III Recall

1) Class I Recall
• Class I recall is for products which could cause serious injury or death
• Class I recall are pretty rare
• The main objective of Class I Recall is to sure that all affected item’s are
removed from the market and from people’s home
• Example :-
1) High level of sulphites

2) High level of heavy metals

2) Class II Recall
• Class II Recall is for products which could cause temporary health problems
• A situation in which use of violative products may cause temporary adverse
health problems
• Example :-
i )Foreign Objects
ii )Pathogens

3) Class III Recall

• Class III recall is for Products which could not caused adverse health
problems
• A situation in which use of violative products Is not likely to cause adverse
health problems
• Example :- I )Aspirin bottle contain 90 tablets instead of 100

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Q. 6) Explain the complaint / Complaint Handling System
Ans:- I) Complaint
• Complaint is defined as a statement that something is wrong or not good
enough. Generally in the pharmaceutical industry, complaints are regarding
the quality of drug product. Complaints may be about: Services, delivery,
quality of product, communication, response time, documentation, billing,
follow up etc.

II) Classification Of complaints

1) A-Type Complaints :- Critical complaints in which product is required to be
withdrawn from the market. Such as
• Adverse Drug Reaction
• Major health hazard causing permanent deficiency or death
• Purity & Safety
• Potency
• Product Stability

2) B-Type Complaints :- Major complaints such as

• Problem with primary packaging of the product.
• Extraneous contamination, mix-ups, etc.
• Chemical/Physical attributes of the product.

3) C-Type Complaints :- Minor complaints such as

• Shortages of Secondary packaging material problem, etc.
• Problem related to labelling / coding of batch details.

III) Complaint Handling System

• Good complaint handling is implemented in pharmaceutical industry
• Complaint handling is done according to GMP guidelines of USA, EU, Brazil
• It is divided into four steps

Step 1 :- Receiving complaint

• It is important to have open channel with customer to receive complaint
doubts and suggestions
 • Complaint are receives in the form of toll free number, e-mails, chat rooms.
• Most used channel was toll free numbers
• Complaint must be forwarded to QA unit for investigation
• Investigation form must contain basic information about customer

Step 2 :- Technical Investigation

• QA unit start investigation of complaint after receiving complaint
• Investigation divided into two phase :-
1. Documentation based investigation
2. Laboratory based investigation
• QA unit analysing the complaint and give conclusion
• There are three possible conclusions are as follows
1. Confirmed complaint
2. Non-confirmed Complaint
3. Tamper suspicion

Step 3 :- Corrective Action And Feedback to customers

• Corrective Action implement on all confirm complaint
• Selection of action depends on nature of complaint
• Investigator take action within specific time zone
• In feedback customer share opinion regarding service
• Explanation letter to customer about results and reason
• Delivery of free product as reimbursement

Step 4 :- Monthly Report and trend analysis

• Monthly report must answer the following question 1. How many
complaint received ?
1. How many were confirmed ?
2. How many were non confirmed?
3. How many were tamper suspicion?
• It Also important to know about
1. Products received most complaint
2. Batches involved
3. Complaint handling cost
• Store reports Data

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Q 7) Explain Analytical validation (10 Mark)

Ans:-
• Analytical method of validation is the process used to prove that analytical
procedure employed for specific test suitable for international use
• Outcome from method validation used to judge quality, reliability and
consistency of analytical results

A) According to ICH Guidelines Four types of methods require Validation

1. Identification tests
2. Quantitative tests
3. Limit tests for the control of impurities
4. Assay

1) Identification Test
• identification test Ensure the identity of analyte in sample

• compare properties of samples

2) Quantitative Test
• check impurities in samples

• Ensure purity of the sample

3) Limit test for the control of impurities

• identify and control small quantities of impurities present in substance
4) Assay
• Quantitative test of the active in samples of the drug substance

B) Types of analytical method Validation

• Types of analytical Validation Are Explains Below

1) Specificity :- It is the ability of the method to assess unequivocally the analyte

in presence of components which may be expected to be present. ((typically
impurities, degradants, matrix)

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2) Linearity :- Ability to obtain test result which are directly proportional to the
concentration of analyte in the sample.

3) Range :- Range of an analytical procedure is interval between the upper and

lower concentration of analyte in the sample for Which it has been demonstrated
that the analytical procedure has a Suitable level of precision, accuracy and
linearity

4) Accuracy :- Accuracy means closeness of test results obtained by that method

to the true Value. The accuracy of an analytical procedure expresses the closeness
of agreement Between the value, which is accepted which is accepted either as a
conventional true value or an accepted reference value and the value found.

5) precision:- Degree of agreement among individual test results when the

method is Applied repeatedly to multiple samplings of a homogenous sample. A
sufficient Number of aliquots of a homogeneous sample are assayed to be able to
calculate Statistically valid estimates of standard deviation or relative standard
deviation.

6) Detection Limit :- Detection limit of an individual analytical procedure is the

lowest Amount of analyte in a sample which Can be defected but not necessarily
qualified, under the stated experimental conditions.

7) Quantification Limit :- LOQ of an individual analytical procedure is the lowest

amount of analyte in a sample which can be quantitatively determined with
suitable precision and accuracy. Several approaches for determining the detection
limit are possible, depending on whether the procedure is a non-instrumental or
instrumental.

8) Robustness :- Robustness of an analytical procedure is a measure of its

capacity to Remain unaffected by small, but deliberate variations (changes like
pH, mobile phase composition, temperature) in method parameters and provides
an indication of its reliability during normal usage.

9) System Stability Testing :- System suitability testing is an integral part of many

analytical procedures. Based on, equipment, electronics, analytical operation etc.

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Q. 8) Write a note on concept of Quality control and Quality
Assurance as per GMP.
Ans.. A] Quality control :- Quality control is the essential part of GMP which is
concerned with sampling , specification ,and testing as well as with the
organization , documentation and release procedure which ensure that the
necessary and relevant tests are carried out , and that materials are not released
for use.
Nor products released for sale or supply , until their quality has been judged to be
satisfactory.
Quality control is an essential operations of the pharmaceutical industry.
II) Objectives of Quality control :-
1. To set the standard / specification for the product.
2. To eliminate / reduce the error and established quality.
3. To test the product and its derivation from the quality specification.
4. To check and evaluate methods and process of production.
5. To find out defects in the product
III) Basic requirements of Quality control :-
1) Adequate facilities, trained personnel and approved procedures are available
for sampling, inspecting and testing starting materials, packaging materials,
intermediate, bulk, and finished products, and where appropriate for monitoring
environmental conditions for GMP purposes;
2) Samples of starting materials, packaging materials, intermediate products, bulk
products and finished products are taken by personnel and by methods approved
by Quality Control;
3) Test methods are validated;
4) Records are made, manually and/or by recording instruments, which
demonstrate that all the required sampling, inspecting and testing procedures
were actually carried out. Any deviations are fully recorded and investigated;

IV) Functions of QC in pharmaceutical industry :-

• Preparation of specification for testing of materials and products.
• Carrying out sampling and testing of materials or products .
• Environment monitoring.
• Analytical methods.
• Evaluation of complaints samples.

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 B] Quality Assurance :- Quality assurance is set of activities for ensuring
quality in products . The activities focus on identifying defects in the actual
products produced.
• Quality management is defined as the aspects of management function
that determines and implements the ‘quality policy ’, i.e. the overall
intention and direction of an organization regarding quality as formally
expressed and authorized by top management.
Quality Assurance = Quality control + GMP / Other Quality systems
I) Objectives of Quality Assurance
1. Supervising good manufacturing practices
2. Verifying the quality of raw material used in manufacturing.

3. Verifying the quality of finished products

III) Requirements of Quality Assurance system as per WHO
1. Pharmaceutical products are designed and developed in a way that takes
account of the requirements of GMP and other associated codes such as
those of good laboratory practices (GLP) and good clinical practice (GCP).
2. Production and control operations are clearly specified in a written form
and GMP requirement are adopted.
3. Arrangement are made for the manufacture ,supply and use of the correct
starting and packaging material.

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Q. 9 ) Write a detailed note on QBD
Ans..
I) Quality By Design :-
• The pharmaceutical quality by design (QBD) is a systematic approach to
development that begins with predefined objectives and emphasizes
product and process understanding and process control based on sound
science and quality risk management.
• Quality by design is emerging the Assurance of safe , effective drug supply
to the customers and also offers promise to significantly improve
manufacturing quality performance.
II) QBD model consists following steps..
1. Establish the project design targets and goals
2. Define the market and customers that will be targeted
3. Discover the market , customers, and societal needs
4. Developed the feature of the new design that will meet the needs
5. Develop or redevelop the processes to produce the feature
III) Elements of QBD..
1. Quality target products profile and define critical quality attributes
2. Product design and understanding & identification of critical material
attributes
3. Design and implement a control strategy
4. Manage products life cycle including continues improvement
IV) Advantages of QBD…
Benefits for industry :-
• Better understanding of the process .
• Less batch failure
• More efficient and effective control of change
• Return on investment / cost saving
V) QBD Tools…
Design of experiments , risk assessment and process analytical technology are
tools that may be used in QbD process when appropriate . they do not check box
requirements.
1. Design of Experiments
2. Risk assessment.
3. Process Analytical technology.

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1.Design of. Experiments :- Design of Experiments structured organized method
for determining the relationship between factors affecting a process and the
response of that process.
• Choose experimental design
• Conduct randomized experiment
• Analyze data
• Create multidimensional surface model
2.Risk Assessment :-
• Risk is defined as the combination of the probability of occurrence of harm
and the severity of that harm. It consists of the identification of hazards and
the analysis and evaluation of risks associated with exposure to those
hazards.

3. Process Analytical technology :-

• A system for designing , analyzing , and controlling manufacturing through
timely measurement of critical quality and performance attributes of raw
and in process materials and process with the goals of ensuring final
product quality.

# The goals of pharmaceutical QBD….

1. To achieve meaningful product quality specifications that are based on clinical

performance
2. To increase process capability and reduce product variability and defects by
enhancing product and process design, understanding, and control
3. To increase product development and manufacturing efficiencies
4. To enhance root cause analysis and post approval change management

# Applications of Quality by design ( QBD)

• A comprehensive systematic approach to pharmaceutical development and

manufacturing advancement in the pharmaceutical development and
manufacturing by QBD can be explained against traditional approach.
• In pharmaceutical development.
• To design a quality product and manufacturing process to consistently
deliver the intended performance of the product.
• Continues improvement enabled within design space.

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Q.10 ) Explain in detail Validation and calibration.
Ans.. A] Validation :- •Validation may be defined as documented evidence that a
process equipment , instruments or product performs as it is expected to
perform. • The process in which the collection and evaluation of data , from
process design stages throughout production , which established scientific
evidence that a process is capable of consistently delivering quality product.

I) Types of validation :-
a) Equipment validation b) Process validation c) Analytical validation.
a) Equipment validation :- The basic component of Pharmaceutical industry is
the 'Equipment' used for manufacturing or analysis. Equipment must be located
,designed constructed ,adapted and maintained to suit the operations to be
carried out.
• Equipment validation is performed through following steps:)
i)Design Qualification
ii) Installation Qualification
iii)Operational Qualification
iv)Performance Qualification
b) Process validation :- Process validation is established evidence which provides
a high degree of assurance that a specific process such as manufacturing of
pharmaceutical dosage forms.
# Types of process validation :-
i)Prospective validation :- This validation is conducted prior to the distribution of
new product.
ii) Retrospective Validation :- It is the establishment of documented evidence of
what a system does or what it purports to do based upon the review & analysis of
existing information.
iii) Concurrent validation :- it is establishment of documented evidence of what a
system does or what it purports to do information generated of system.
c) Analytical method validation :- Method validation is the process used to
confirm that the analytical procedure employed for a specific test is suitable for
its intended use.
# Common types:-
• Identification test
• Quantitative tests for impurities contents
• Limit test for the control of impurities

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B] Calibration :-
• Purpose of calibration is to demonstrate that, a particular Instrument or
device produces results with in specified limits by comparisons with those
produced by a reference or traceable standard over an appropriate range
of measurements.
• Calibration is an instruments is the process of determining its accuracy.
• The process involves obtaining a reading from the instruments and
measuring its variation from the reading obtained from a standard
instrument.
II) Importance of Calibration :-
1. Calibration is important to get accurate result and to minimize the
errors.
2. Calibration minimizes uncertainty during analysis and provide
confidence to the analyst.
3. Accuracy in analytical tests assures the quality of the product.
4. Calibration helps to reduce resting and rework
5. Calibration performance of the organization in quality audits.
III) Types of Calibration :- The process of testing calibration can be performed on
a number of products and types of equipment , across multiple sectors.

A)Pressure Calibration :- This is a widely used Calibration process in which gas

and hydraulic pressure are measured across a broad spectrum. A number of
pressure balance and calibrators are generally use. Ex – Barometers , Digital
indicators , Analogue pressure gauges , Transmitter

B)Temperature and Humidity Calibration :- Temperature calibration usually takes

place in controlled environment. A number of different types of equipment can
be tested using temperature calibration ,such as Dial Thermometer , weather
stations , chambers , Thermal cameras

C)Electrical Calibration :- The Calibration service is used to measure voltage ,

current frequency and resistance. Ex – clamp meters , counter timers , electrical
meters , loop testers , data loggers

D)Mechanical Calibration :- Generally speaking mechanical calibration housing

facilities will be temperature control. Example , Accelerometer , micrometer.. Etc..

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Q..11 ) Write a note on Good warehousing practice
Ans.. I) Warehouse: The warehouse is the building used for storage of raw
materials , packaging and packs of finished products under suitable storage
conditions.
• So warehouses for storage if pharmaceutical products should be laid out
with all required storage areas , good assembly ,packing ,receiving and
dispatching point.
• All the facilities should be designed in such a way that dispensing errors are
reduced to minimum to achieve quality and ultimately staff and patients
are provided with a safe environment.
Warehousing :- It is an activity that involves the storage of goods until they
are dispatched to the market.

II) Good warehousing practices :- Good warehousing practices includes

following –
1. Organization and management
2. Personnel
3. Premises
4. Equipment
5. Sanitation
6. Temperature and environment control
7. Materials management
8. Packing
9. Dispatch and receipt
10. Documentation and records
11. Returned product
12. Recalled products
13. Complaints products
14. Repacking and relabeling

1. Organization and management - Organization structure for each entity

should be well defined to identify responsibility , authorities and
interrelationships of all personal working in the warehouse.
• Organization and management can be in following hire ache
Warehouse/store head, store officer for raw material, packaging
material and finished product followed by workers. Duties &
responsibilities shall be clearly defined through documentation

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2. Personnel – There should be an adequate number of competent personnel
involved in all stages of the distribution of pharmaceutical products to
maintain quality.
• The warehouse shall provide necessary training from time to time to
achieve needed competency.
3. Premises - • Premises should be of suitable size and construction to
facilitate cleaning, maintenance and orderly, segregated storage.
• Storage areas must be designed to provide adequate lightening,
ventilation, temperature, sanitation, humidity, space, equipment, and
security conditions.
4. Equipment - .There should be a planned preventative maintenance
programme in place, recording and control equipment should be calibrated
and checked at defined intervals by appropriate methods.
5. Sanitation – A written sanitation program should be in place indicating the
frequency and method for cleaning the facility.
• Storage area should be cleaned and accumulated waste removed at
regular intervals
6. Temperature and environment control - All drug products must be stored
at appropriate conditions as stated on the label of the product.
7. Materials management – All the necessary precaution for receipt,
segregation ,storage and dispatch should be followed for raw material ,
packing material and finished products
8. Packing – The identification of the products is not lost
• The products does not contaminate and is not contaminated by other
products or materials.
9. Dispatch and receipt – while dispatch the product be taken that product
will remain intact and its required storage conditions will be maintained.
10. Documentation & record - All the instruction , records should be well
documented. Each and every activity in storage area should be
documented.
11.Returned product – All the returned product should be received and
storage as per standard procedures. The document for the same should be
maintained properly.
12. Recalled product – There should be a defined system and written
procedure for any pharmaceutical products recall for any reasons. Such
products should be maintained carefully .

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Q.12 ) Write a detailed note on ICH guidelines including QSEM
& ICH stability testing guidelines.
Ans:-
I) ICH:- International Council For Harmonization.
• It’s for the technical requirements for pharmaceutical for human use (ICH).
Unique in bringing together the regulatory authorities and pharmaceutical
industry.
• Inception in 1990, ICH has gradually evolved, to respond to the increasingly
global face of drug development.
• Ensure that safe, effective, high quality medicines are developed and
registered in the most resource-efficient manner.
• October 2015, 16 Members and 32 Observers. Included in it.
• It involving both regulators and research based industry representatives of
the Europe (EU), Japan and the United State (US).
• Scientific and technical discussions of the testing procedures required to
assess and ensure the safety, quality and efficacy of medicines.
• This guideline applies to the systems supporting the development and
manufacture of pharmaceutical drug substances (i.e., API; and drug
products, including biotechnology and biological products, throughout the
product lifecycle

II) QSEM Guidelines

They are categorized into 4 types.
A) Quality :- Relating to chemical and pharmaceutical Quality assurance
B) Safety :- Relating to in vitro and in vivo pre-clinical studies.
C) Efficacy :- Relating to clinical studies in human subject.
D) Multidisciplinary :- Cross-cutting topics which do not fit uniquely into
one of the above categories.

- Quality (Q) :-
• Q1A Stability
• Q2 Analytical validation
• Q3A Impurities
• Q4 Pharmacopoeias
• Q5A Quality of Biotechnological product
• Q6A Specification

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 • Q7 GMP
• Q8 Pharmaceutical Development
• Lifecycle Management
- Safety (S) :-
• Toxicity Testing • Reproductive Toxicology
• Biotechnology Products • Pharmacology Studies
- Efficacy (E) :-
• Pharmacovigilance
• Clinical Study Reports
• Dose – Response Studies
• Ethnic Factors
• Good clinical Practice
• Genomic sampling
• Safety Data Collection
• Clinical Safety
- Multidisciplinary (M) :-
• Electronic Standard
• Nonclinical Safety Studies
• Gene therapy
• Mutagenic Impurities
• Common Technical Document
• eCTD
III) ICH stability testing guidelines
• Stability Testing of new Drug Substances & products
• Photostability Testing Of new Drug Substances & Product
• New Dosage Forms
• Bracketing & Matrixing Designs for Stability Testing of new Drug
substances & products
• Evaluation of stability Data
• Stability Data package for registration application in climatic zones III
& IV
• Data from stability studies should be provided on at least three
primary batches of the drug product.
• Stability of drug substance and drug product for registration of
application of NCE or associated drug, within three regions of ICH i. e;
EU, Japan, USA .

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Q. 13 ) Write a Note on NABL
Ans:-
I) NABL
• Accreditation is the formal recognition, authorization and registration of a
laboratory that has demonstrated its capability, competence and credibility
to carry out the tasks it is claiming to be able to do.

• The National Accreditation Board for Testing and Calibration Laboratories

(NABL) is an autonomous body under the aegis of the Dept. of Science and
Technology, Govt. of India, and is registered under the Societies Act. NABL,
which was initially established with the objective to provide accreditation
to testing and calibration laboratories, later on extended its services to the
clinical laboratories in our country.

• Govt. of India has authorized NABL as the sole accreditation body for
testing and calibration laboratories.

II) Principle for Accreditation

• It is very important for a laboratory to make a definite plan for

obtaining accreditation and nominate a responsible person as
quality manager (who should be familiar with the laboratory's
existing quality system) to co-ordinate all activities related to seeking
accreditation.
• The laboratory should carry out the following important tasks
towards getting ready for accreditation:
1) contact NABL Secretariat with a’ request for procuring relevant NABL
documents.
2) Get fully acquainted with all relevant documents understand the
assessment procedure and methodology of making an application.
3) Train a person on Quality Management System and Internal Audit.
4) Prepare Quality Manual as per ISO 15189 standards.
5) Prepare Standard Operating Procedure for each investigation carried out
in the laboratory.
6) Ensure calibration of instruments / equipment. Only NA accredited
calibration laboratories are authorized to pro calibration.

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 III) Accreditation process

• An applicant laboratory is expected to submit to NABL 5 copies of the

Application and 5 copies of Quality Manual.

• The Quality Manual will be forwarded by NABL to a Lead Assessor to judge

the adequacy of the Quality Manual as to whether it is in compliance with
ISO 15189 standards.

• Thereafter the Lead Assessor will conduct a Pre-assessment of the

laboratory for one day. Based on the Pre-Assessment Report the laboratory
may have to take certain corrective actions, so as to be fully prepared for
the final assessment.

• It is essential for the applicant as well as accredited laboratories to

satisfactorily participate in Proficiency testing/ Inter-laboratory
comparisons/External quality assessment programme as Asia Pacific
Laboratory Accreditation Cooperation (APLAC) Mutual Recognition
Arrangement calls for mandatory participation in such Programmes.

• Finally when the laboratory is ready, the Lead Assessor and a team of
technical assessors will conduct the final assessment. The number of
technical assessors will depend on the number of disciplines applied for.
The accreditation process involves a thorough assessment of all the
elements of the laboratory that contribute to the production of accurate
and reliable test data.

• These elements include staffing, training, supervision, quality Control,

equipment, recording and reporting of test results and the environment in
which the laboratory operates. The laboratory may have to take certain
corrective actions, after the final assessment.

• After satisfactory corrective actions are taken by the laboratory (within a

period of 3 months), the Accreditation Committee will examine the report
and if satisfied recommend accreditation.

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Q. 14) Write a note on Good laboratory practices (GLP)
Ans..
I) Definition
• Good laboratory practices is defined as a quality system concerned with
the organization process and the conditions under which non – clinical
health and environment safety studies as planned , performed ,
monitored , recorded , archived , reported.
• Good laboratory practices applies to non clinical studies conducted for
the assessment of the safety or efficacy of chemicals
• GLP , a data quality system , should not be contused with standards for
laboratory safety – appropriate gloves , glasses and clothing to handle
lab materials safety.
II) General provisions –
1. The laboratory should have adequate manpower to implement GLP
practices.
2. Each person working in the laboratory should provide adequate training.
3. The laboratory should have an adequate safety system to work safety in
the laboratory.
4. The laboratory should be well designed and have adequate space for
working properly
5. The laboratory should be well equipped and all the facilities should be
provided.
6. All the equipment and instruments should be calibrated and validated
III) Facilities –
• The minimum required facilities should be of suitable size construction
and location to meet the requirements of the study and minimize
disturbances that would interfere with the validity of the study
1) Animal care facilities
• There should be storage areas , needed , for feed bedding , supplies and
equipment.
• Storage areas for feed and bedding shall be separated from areas
housing the test systems and shall be protected against infestations or
contamination.
1. Laboratory operations areas
• Separate laboratory space shall be provided , as needed , for the
performance of the routine required by nonclinical laboratory studies.

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15) Write a note on B) validation protocol:-
• A written plan stating how
validation master plan and
validation will be conducted,
validation protocol including test parameters, product
Ans:- A) Validation master plan:-
characteristics, production and
• The validation master plan should
• packaging equipment, and decision
provide an overview of the entire
points on what constitutes
validation operation
acceptable test results
• its organizational structure, its
• This document should give details of
content and planning
critical steps of the manufacturing
• The main elements of it being
process that should be measured,
them list/inventory of the items to
the allowable.
be validated and the planning
• range of variability and the manner
schedule
in which the system will be tested.
• It should comprise all prospective,
• The validation protocol provides a
concurrent and retrospective
synopsis of what is hoped to be
validations as well as revalidation
accomplished
#_The format and content should # The validation protocol should be
include: numbered, signed and dated that are
• Introduction: validation policy, given below:-
scope, location and schedule • Objectives, scope of coverage of the
• Organizational structure: personnel validation study Validation team
responsibilities membership, their qualifications
• Specific process considerations that and responsibilities
are critical and those requiring • Type of validation prospective,
extra attention. concurrent, retrospective, re-
• Key acceptance criteria. validation
• Documentation format. • Number and selection of batches to
• Reference to the required SOPs. be on the validation study
• Time plans of each validation • Statistical tools to be used in the
project and sub-project analysis of data
• List of products/ processes/systems • Training requirements for the
to be validated, summarized in a processing operators
matrix format, validation approach.

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Q. 16 )Calibration OF pH Q. 17) Qualification of UV-
Meter Visible Spectrophotometer
Ans:- #_ Calibration Of pH Meter Ans:-
1) Instrument: pH-meter (EQUIP- #_Qualification of UV-Visible
TRONICS) Spectrophotometer
2) Connect the instrument to mains
and allow it to warm up for about • UV-Visible spectroscopy is an
10 minutes. analytical method that measures
3) Prepare three buffer solutions 9.2 the absorbance of UV or Visible
pH, 4.0 pH and 7.0 pH using radiation passing through an
standard buffers in distilled water. analyte. Procedure and instrument
4) Adjust the temperature dial to the parameters used for qualification of
temperature of the solution and UV Visible spectrophotometer are
also put the MODE switch in the discussed below
position.
5) Dip the electrode fully in 7.00 pH • Name of instrument: UV-Visible
solution and wait for reading to be spectrophotometer
stabilized. Adjust the Asymm. Pot.
Knob (with screwdriver) to get a • Model of instrument: Shimadzu
reading a reading of 7.00. 1800 Purpose: To calibrate UV-
6) Now immerse the electrode in
Visible spectrophotometer.
either 9.2 or 4.0 pH buffer and
adjust the ‘SLOPE’ knob so that
• Calibration parameters:
display reads the pH of buffer and
tighten the nut.
1) Control of absorbance
7) Repeat step four and five again,
each time electrodes are to be
2) Resolution power
washed in distilled water.
8) To check, immerse the electrode in
3) Limit of stray light
third buffer to verify.
9) Periodic calibration to be done as
4) Wavelength accuracy, Resolution
follows:
and Baseline flatness (inbuilt test)
• New Electrode- daily for one week.
• After 1 week of usage- twice per • Frequency of calibration : Every Six
week
Months
• After 4 weeks of usage- once per 3
months

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Q.18) Write a short note on Q. 19) Write a short note on
Personal Training. personal Hygiene.
Ans:- Ans:- Personal Hygiene :-
# Personal Training:- 1. Providing training to a person
• All workers, mangers and people’s working in the manufacturing unit.
have well trained. 2. Health and medical check-up before
1. Maintaining personal hygiene and joining or at the start of the
gowning, wearing gloves, informing manufacturing year.
to authority if he/she is suffering 3. Strict gowning procedure before
from infectious disease. entering the factory premises.
2. Personal safety-wearing safety 4. Making compulsory wearing of
goggles while handling dangerous hood, gown, mask, gloves while
and toxic chemicals. working in the factory premises.
3. Handling of different equipment - 5. Placing the disinfectant solution on
Operation of the tablet punching various locations of the factory.
machine. 6. Prohibition of eating, drinking,
4. Handling and maintenance of chewing, or smoking in working
different document-filling batch premises.
manufacturing records. A) Personal Record:-
5. Performing daily duties assigned by 1. Training report of each personnel
the head- QC chemist is trained for 2. Each person should fill and submit
sampling, testing, and handling of the training report to the QA
analytical equipment. departments
6. Preparation and facing quality B) Entry & exit record :-
audits- production officers should 1. Each person should record the entry
be trained on how to prepare the and exit details in a document kept at
production department and face the gate of the factory premises with
the FDA audit all the details like name, time, date,
7. Quality policies of the company- signature, etc.
fresher candidates should be given C) Personal gowning record :-
the training to understand the 1. Each person should enter the
quality policies of companies. like gowning details like time, date, etc. of
the rules and regulations of the gowning each day.
company while working in the D) Medical health check-up
manufacturing area E) Logbook records

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Q.20) Write a Note on Personal 3) Head of the quality control
department :-
Responsibility.
Ans:- • Organize advanced training
I) Personal Responsibility:- Each person programs for all staff working in the
should be provided with clearly written department
job responsibilities. • Monitor the day to day working in
the QC department.
II) Key personnel:- The head of various • Prepare the QC department for
departments in pharmaceutical audit.
manufacturing units are called key
personnel. 4) Head of Store Department :-

1. Head of the Plant / Unit • Organize advanced training

2. Head of quality control department programs for all staff working in the
3. Head of quality assurance department.
department • Monitor the day to day working of
4. Head of the store department the store department.
5. Head of the production department • prepare the packaging department
6. Head of the packaging department for audit.
5) Head of the production department
1) Head of the Plant :-
• Monitor the day to day working in
• Provide training for QA staff the production department.
regularly • Prepare the production department
• Monitor the working of the for audit.
department • Manage and proper utilization of
• Assign duties to persons working in the manpower of department
the department
2) Head of quality assurance 6) Head of packaging department
department :-
• Organize advanced training
• Monitoring of manufacturing programs for all staff working in the
activities department.
• Monitoring of QC department • Monitor the day to day working in
• Monitoring of packaging the packaging department.
department • Prepare the packaging department
• Store department for audit.

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Q.21) Quality control test for Q. 22) Quality Review
primary, secondary and Tertiary Ans:-
and other secondary packaging • Quality review is an evaluation
material conducted at regular periodic or
Ans:- I) Quality control :- rolling registered medicinal reviews
• Quality control is the backbone of of standard of each drug product.
pharmaceutical industry as defects • With the view to verify the
in packaging can prove to be consistency of existing process and
harmful for dosage forms. to check the appropriateness of
• Quality control of packaging current specifications and to
component starts at the design highlight any tends in order to
stage. determine the need to change any
II) Primary packaging material:- drug product specifications or the
• These are material which directly or control procedures.
comes in contact with the • It is an effective quality
pharmaceutical product e.g improvement tool to the
ampoules, vials, rubber plugs, consistency of manufacturing
bottles, foils etc. process and overall quality of the
• These products need more careful product.
handling during receiving, storage, • A Good Manufacturing Practice
sampling, dispensing and during ensures that the products are
use. consistently produced and
III) Secondary packaging material:- controlled according to quality
• All those materials which come in standards. Annual Product Quality
contact with the sealed primary Reviews (APQR) not only are
packaging materials are called required by GMP but also required
Secondary Packaging Materials for robust quality improvement for
• e.g. cartons, labels, inserts etc. manufacturing the pharmaceutical
product.
IV) Tertiary and other secondary • It is a written report that is required
packaging materials: for every drug product, based on
• All packaging materials other than data collected at least annually.
primary and secondary are • It is designed to minimize the risks
classified in this category involved in any pharmaceutical
• e. g. shippers, nylon straps, external production that cannot be
labels, gum tapes etc. eliminated through testing the final
product.

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Q.23) Write a note on sterile area including environmental
control and contamination control.
Ans…

A) Environmental control :-

• The environmental control maintained is different for different areas .

• Stringent environmental control is required before and during the
processing of parenteral to assure an area free from contamination and
where there is no accumulation of dust particle’s , lint , viable
microorganism.
• Production environment is constantly monitored and evaluated to assure
that the required aseptic conditions are maintained.
• Sterile products are very critical and sensitive in nature, hence it requires
very high degree of precaution and prevention is required in ts preparation
and there shall be strict compliance with standards prescribed by
regulatory authorities.
• Air handling units for sterile product shall be different from those of other
areas.

# The most common environmental control includes following.

1. Thermal pollution and control :- various off stream cooling system are
required to handle thermal discharge from process . there different ways
for controlling thermal pollution which includes wet cooling towers and dry
cooling towers.

2. Water pollution :- There is a great problem to handling a liquid waste

effluent is more complex then gas effluent . The treatment could be done
by , physical treatment , chemical treatment and biological treatment.

3. Air control :- There are two major categories ;

a) Those suitable for removing particular matter.

b) Those associated with removing gaseous pollutants.
B) Control of contamination :

• The words contamination covers a range of different substance . Simply ,it is

stuff in the wrong place , or where it should not be . The various possible
forms of contamination can be classified into two main types :-

I) sources of contamination and its prevention :- The environment around us

includes water , raw materials , containers and closures , people , equipment etc.

1. Atmospheric contamination :-
• Atmospheric condition during manufacturing as well as during storage
affects the quality of final preparation.
• This contaminants may get incorporated into the end product either during
the process of manufacturing or during purification.

2. Fluid contamination :-
• Besides serving as the most common solvents in pharmaceutical industry,
water also serve as the greatest solvents solvent in pharmaceutical
industry.
• Therefore usages of water for washing the machineries and working areas
may leave traces of these contaminants

3. Transfer contaminants :-
• Transfer contaminant refers to the contaminants sourced from
personnel and wheels of trolleys used for transport of goods .
• Personal working in aseptic areas , if suffering from cold , allergies ,
Detematological condition or any similar illnesses carry multiple
microorganism

II) The control of contamination can be achieved with the aid of the following
method .
• Adequate premises
• Good ventilation & dedusting system
• Closed production system
• Validated cleaning procedures
• Unidirectional Airflow protection
Q 24) Write a note on plant layout
Ans.. I) Plant layout – Pharmaceutical plant layout / factory layout refers to the
allocation of space and the arrangement of machine , furniture and their other
important administration and necessary services needed in a production process
within a factory building in other to perform the various unit operations involved
in the manufacturing process of dosage forms in a cost effective manner and with
the least amount of handling in processing the product from the receipt of raw
materials through the distribution of the finished product.
II) Features of good pharmaceutical plant layout –
1. There should be adequate floor space for machines installation and
utilization
2. The machines should be properly arranged to facilitate minimum materials
handling is necessary for low cost processing.
3. The layout should facilitate smooth and continues flow of producing
process from one point to another any form of delay
III) Advantages of a good pharmaceutical plant layout :-
• Optimum use of available floor space for production operations
• Improved quality of product due to reduced chances of cross
contamination
• Low cost of materials handling
• Minimized loss due to waste and spoilage
IV) Types of plant layout :- ( are of two to types )
1] Process layout - more effective supervision can be achieved
• Division of labour can be provided
• High scope for expansion.
2] Products or straight line layout –
• Process of work will be quick and smooth
• Cost of materials handling will be reduced
V) Factor influencing plant layout –
• New site development or additional to developed site
• Types of process and product control
• Space available and space required
• Health and safety consideration
• Waste disposal problems
• Possible future expansion.
Q. 25) Discuss various quality 4) Light absorption test :-
• The sample solution is filtered
control tests for closures.
through a 0.5 micron filter and its
Ans:- absorbance is measured at 220 to
1) Sterility test 360 nm.
2) Fragmentation test • The absorbance should not be
3) Self sealability more than 2.0
4) Light absorption test 5) Reducing Substance :-
5) Reducing Substance • Carry out the test within 4 hours of
6) Residue on Evaporation preparing sample solution (Solution
7) Penetrability A)
1) Sterility test :- • Take 20 ml of sample solution, add
• This test is used to determine the 1 ml 1 M H2SO4 and 20 ml of 0.002
sterility of closures and the M KMnO4, and boil for 3 minutes
presence of any foreign particles or • Similarly, repeat the procedure for
microorganisms in the closure blank and the difference between
• Sterilize the closure in the titration volumes should not be
autoclave at 64°C at 0.7 pKa more than 0.7 ml
pressure. 6) Residue on Evaporation :-
• Determine the presence of any • Evaporate 50.0 ml of sample
microorganism using culture media. solution (Solution A) to dryness on a
2) Fragmentation test :- water bath and dry at 105°C. The
• This test is applicable to closures residue weighs not more than 4.0
intended to be pierced by a mg.
hypodermic needle. 7) Penetrability :-
• Close the vials with the prepared • This is measured to check force
closures, secure with a cap and required to make a hypodermic
allow to stand for 16 hours. needle to penetrate easily through
• For closures that are intended to the closure
be used for dry preparations, close • It is measured by using a piercing
12 clean vials with prepared machine.
closures. • A piercing value must not exceed
3) Self sealability :- the stated value.
• Fill 10 suitable vials with water to • If it exceeds, the hypodermic
nominal volume, close the vials with needle can be damaged as a result
the "prepared" closures and secure of undesirable hardness of closures.
with a cap.
Q.26) Write a note on Q.27) Write a note on raw
equipment selection. materials.
Ans:- Equipment:- 1) Any piece of plant, Ans :-
machinery, instrument etc. which is # Raw Materials:-
used for carrying out a specific activity A) starting material used in
or manufacturing of finished product.
operation. Ex. Mixer, dryer, HPLC. B) Cost of raw material
2) Equipment can be a single piece or it C) Identity, purity & quality of raw
may consists of a set of integrated material
pieces to perform a purification plant. D) Vendor selection:- should buy from
Common activity e.g. water purification approved suppliers & manufacturers.
plant. E) All raw materials should check this
1. Design :- A) The design of the thing
equipment should meet user • Name of supplier
requirements, for which the • Name of product
equipment is selected. • Batch number
B) URS will vary from equipment • Dt. Of manufacturing & Expire
to equipment. date
2. Size :- A) decided based on the • Conditions of container &
volumes of materials, which we are materials
going to handle. Batch sizes are also F) Storage Condition:-Clearly show
directly related to the size of the about temperature, humidity, away
processing equipment. from direct sunlight, sterile material.
B) Physical dimensions of the G) Labels on raw material
machinery. • Name & code number of product
C) Holding and output capacity of the • Batch number
equipment. • Storage conditions
3. Location :- A) locating the • Melting & boiling point.
equipment in the plant depends upon
• Molecular weight
the logical process movement.
• Expiry date of product
B) Utility services required.
• Handling hazards associated with raw
C) Material handling & movement
material.
D) Movement for processing & cleaning
• Precautions
4. Construction :-
A) Material of construction • Safety measures
B) Ease of cleaning the equipment & • Instructions for sampling & handling
surrounding area • Frequency of re-examination of
C) Ease of maintenance of equipment stored raw material.
Q. 28) Diff Between Calibration & Validation
Ans:-

Calibration Validation
1) Calibration is a demonstration 1) Validation is a documented
that a particular instrument or program that provides high
device produce results within degree of assurance that a
specified limits . By comparisons specific process, equipment,
with those produced by a method or system consistently
reference or traceable standards produces a result meeting pre-
over an appropriate range of determined acceptance criteria.
measurements

2) In calibration performance of an 2) No such reference standards are

instrument or device is comparing used in validation program.
against a reference standard.

3) Calibration ensures that 3) Validation provides documented

instrument or measuring devices evidence that a process,
producing accurate results. equipment, method or system
produces consistent results (in
other words, it ensures that
uniforms batches are produced).

4) Shall be performed periodically, 4) No such requirements. Shall be ng

to identify the ‘drift’ of the performed when changes or
measuring device or equipment modifications happen to the
and make them accurate. existing system or once
revalidation period is reached.

5) Shall be performed as per 5) Shall be performed as per

calibration SOP. validation protocol.
Q 29 ). Write note on master formula record .
Ans:
I) Definition - Master formula record (MFR) is a master document for any
pharmaceutical product. It contains all information about the manufacturing
process for the product. MFR is prepared by the research and development team
of the company and all other documents like BMR and BPR are prepared using
MFR by the manufacturing units.

II) Components of master production and control record

• Name, strength, composition, physical and chemical description, method
of administration Name of active ingredient and excipients, total weight of
dosage unit
• Weight/measure of each component
• Calculated excess of component.
• Theoretical weight Maximum %, Minimum% of theoretical yield.
• Description of containers, closures, labels, labelling packaging materials.
• Instructions, sampling testing procedures, specifications, special
notations, precautions.

III) Step in preparation of MFR : The production department in association with

F&D Prepare MFR. It is divided into tow section
1) Manufacturing
2) Packaging

1) The secondary page of manufacturing section :

• shall include-Process steps to be monitored Subsequent pages shall include
the processes to be monitored. The list of equipment, machines, utensils to
be used, shall be described. The subsequent page shall include any special
precautions to be taken for the product during manufacturing and packing.
The same page should also include Batch Manufacturing Formula .
2) The secondary page of packaging section :
• of MFR should include complete list of all the packaging materials required
for a standard batch size, including quantities, sizes and type: Include line
clearance checking during batch cording and batch packaging operation:
Includes reconciliation of printed and unprinted packaging materials with
acceptable lim.
Q. 30 ) Write a note on quality audit
Ans –
1) Definition
- Quality audit is the process of systematic examination of a quality system
carried out by an internal or external quality auditor or an audit team.

2) Types of Audit
• A first party audit is an audit performed by an organization on itself i.e. an
internal audit.
• A second party audit is an audit performed by one organization on its own
behalf on another usually on a supplier by a customer
3) Phases of audit

• . Phase 1-Preparation: This phase precedes the actual review meeting. It is

the responsibility of the chairman and presenter to organize the quality
review and notify all those invited

• Phase 2- The review meeting: The central phase of the quality review
process is the review meeting itself.

• Phase -3 – the follow up following the quality review meeting there should
be a follow up period during which the error identified at the review that
were committed to the follow up the action list are rectified and signed
4) Principal of auditing
• Ethical conduct: the foundation of professionalism ,trust , integrity’s,
confidentiality and discretion are essential to auditing
• Fair presentation: the obligation to reports truth fully and accurately

5) Types of quality audits

i. Adequacy audit /documents review

ii. Compliance audit/ on -site audit
iii. External audit
iv. Internal audit
v. Product or process audit
Q. 31 ) Writer the on SOP

Ans 1) Definition - An SOP is a procedure specific to your operation that

describes the activities necessary to complete tasks in accordance with industry
regulations, provincial laws or even just your own standards for running your
business. Any document that is a “how to” falls into the category of procedures

2) Benefit of sop
• Standard Operating Procedure (SOP) is a set of written instructions that
document a routine or repetitive activity which is followed by employees in
an organization.
• To ensure that processes continue uninterrupted and are completed on a
prescribed schedule. Ensure against process shut-downs caused by
equipment failure or other facility damage.
3) SOP Requirements
• Management, control, and retention of superseded or obsolete
documents.
• Document archival and retrieval procedure.
• Handling, archival, retrieval, and retention of electronic
records/documents.
• Procedure for control of electronic signatures.
4) Format of Technical sop
In General technical sop will consists of five elements :
• Title Page.
• Table of content
• Procedures
• Quality assurance/ Quality control
• Reference
I. Title
II. Table of content
III. Procedures - The following are topics that may be appropriate for inclusion
in technic SOPs. Not all will apply to every procedure or work process being
detailed.
Q. 32) Describe Design And Construction
Ans...
I) Design And Construction

• building and facilities use in the manufacture of intermediate and

APIs should be located , designed and constructed to facilitate
cleaning , maintenance and operations as appropriate to the
types and stage of manufacture.
• Facilities should be designed to minimize potential contamination.
Where microbiological specification have been established for the
intermediate or APIs , facilities should also be designed to limit
exposure to objectionable microbiological contaminants as
appropriate.
• Building and facilities should have adequate space for the orderly
placement of equipment and material to prevent mix ups and
contamination.
• Laboratory areas / operations should normally be separated from
production areas. Some laboratory areas in particular those used
for in process controls , can be located in production areas ,
provided the operations of the production process do not
adversely affect the accuracy of the laboratory measurement.
# There should be defined areas or other control systems for the
following activities :-

1. Receipt , identification , sampling , and quarantine of incoming

materials , pending release or rejection .
2. Quarantine before release or rejection of intermediate and APIs
3. Sampling of intermediate and APIs
4. Holding rejected materials before further disposition
5. Storage of released materials
6. Production operations
7. Packaging and labelling operations
Q 33) DOCUMENTS AND RECORDS 21) angel control
22) Quality system related
Ans:-
documents
• Documentation and records are 23) Quality manual
used throughout the manufacturing 24) . Validation protocols and
process, as well as supporting reports
processes (e.g. Quality Control or 25) Deviation reports
Quality Assurance), must meet the 26) Audit plans
basic requirements of Good 27) Electronic and hard-copy
Documentation Process. These Quality records (e.g. non-
include (but are not limited to): conformance, corrective and
preventative actions, internal
inspection, change control,
1) Batch Record Forms
2) Bills of Materials (BOMs) training records etc.)
28) Validation Master Plans and
3) Specifications
validation documents including
4) Policies
5) Protocols URS, DQ, FAT, IQ, OQ PQ, and
Validation reports.
6) Standard Operating Procedures
29) Test material related
(SOPs)
7) Work Instructions (WIs) documents including product
specification, test material receipt
8) Checklists
9) Forms/Log sheets and reports.
30) Personnel related documents
10) Certificate of Analyses or
including training records.
Certificate of Compliance
11) Technical transfer reports 31) Facility related documents
including floor plans, HVAC plans,
12) Technical agreements
13) Technical reports. and environmental specifications.
14) Test Methods 32) Deviation forms including
unplanned deviations and system
15) Training Assessments
failure investigation
16) Records
17) Worksheets, note books, and
log books
18) Validation documentation
19) Manufacturing and packaging
instructions
20) Confidentiality agreements
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