GOOD MANUFACTURING PRACTICE

(GMP) GUIDELINES FOR

MANUFACTURERS OF COSMOTIC
PRODUCTS
BY: SILTAN M.

SEP, 2023
 OUTLINE

 PREAMBLE
 INTRODUCTION  EQUIPMENT
 GENERAL CONSIDERATION  INSTALATION AND LOCATION
 QUALITY MANAGEMENT  MAINTENANCE
SYSTEM  HYIGENE AND SANITATION
 PERSONNEL  EQUIPMENT AND APPARATUS
 ORGANIZATION,QUALIFICATION  VERIFICATION OF MATERIALS
AND RESPONSIBLTIES
 REJECTED MATERIALS
 TRAINING  BATCH NUMBERING SYSTEM
 PREAMBLE
 The GMP Guidelines have been produced to offer assistance to
the cosmetic industry in compliance with the provisions of the
cosmetic directive.
 The Good Manufacturing Practices presented here is only a
general guideline for the manufacturers to develop its own
internal quality management system and procedures.
 The important objective must be met in any case, i.e. the final
products must meet the quality standards appropriate to their
intended use to assure consumer’s health and benefit.
 INTRODUCTION
The objective of the cosmetic good
manufacturing practice (GMP)guidelines is
to ensure that products are consistently
manufactured and controlled to the specified
quality. It is concerned with all aspects of
production and quality control.
GENERAL CONSIDERATION
 The quality of a product depends on the starting
materials, production and quality control processes,
building, equipment and personnel involved.
 In the manufacture of cosmetic products, overall control
and monitoring is essential to ensure that the consumer
receives products of specified quality.
QUALITY MANAGEMENT SYSTEM
 A quality system should be developed, established and
implemented as a means by which stated policies and objectives
will be achieved.
 Should define the organizational structure, functions,
responsibilities, procedures, instructions, processes and
resources for implementing the quality management.
 The quality system should be structured and adapted to the
company’s activities and to the nature of its products and should
take into consideration appropriate elements stated in this
Guidelines.
The quality system operation should ensure that if
necessary, samples of starting materials, intermediate,
and finished products are taken, tested (if necessary) to
determine their release or rejection on the basis of test
results and other available evidence related to quality.
 PERSONNEL
 There should be an adequate number of personnel
having knowledge, experience, skill and capabilities
relevant to their assigned function. They should be in
good health and capable of handling the duties assigned
to them.
 ORGANIZATION, QUALIFICATION AND
RESPONSIBILITIES
 The organizational structure of the company shall be such that the
production and the quality control sections are headed by different
persons, neither of whom shall be responsible to the other.
 The head of production should be adequately trained and
experienced in cosmetic manufacturing.
 They should have authority and responsibilities to manage
production of products covering operations, equipment,
production personnel, production areas and records.

CONT……..
 They should have the authority to designate/ assign when
appropriate, personnel, to approve starting materials,
intermediates, bulk and finished products that meet the
specification or to reject those which do not conform to the
relevant.
 The responsibilities and authority of key personnel should be
clearly defined.
 An adequate number of trained personnel should be
appointed to execute direct supervision in each section of the
production and the quality control unit.
 TRAINING
 All personnel directly involved in the manufacturing
activities should be appropriately trained in manufacturing
operations in accordance to GMP principles.
Special attention should be given to training of personnel
working with any hazardous materials.
 Training in GMP should be conducted on a continuous
basis.
 Records of training should be maintained and its
effectiveness assessed periodically.
 PREMISES
The premises for manufacturing should be suitably located,
designed, constructed and maintained.
 Effective measures should be taken to avoid any contamination

from the surrounding environment and from pests.

Cosmetic products can share the same premises and equipment
provided that due care should be exercised to prevent cross
contamination and risk of mix-up.
Defined areas should be provided for, wherever possible and
applicable: -

CONT……..
 Storage of finished products
Materials receiving.
Incoming goods
Starting materials storage
 Material sampling.
 Weighing and dispensing.
 Equipment washing.
 Processing.
 Storage of bulk products.
 Packaging.
 Quarantine storage before final release of products
 EQUIPMENT
 Equipment should be designed and located to suit the
production of the product.
 Equipment should not adversely affect the product through
leaking valves, lubricant drips and through inappropriate
modifications or adaptations.
 Equipment should be easily cleaned.
 Equipment used for flammable substances should be
explosion proof.
 INSTALLATION AND LOCATION
o Equipment should be located to avoid congestion and
should be properly identified to assure that products do
not become admixed or confused with one another.
o Water, steam and pressure or vacuum lines, where
applicable, should be installed so as to be easily
accessible during all phases of operation. They should
be clearly identified.
o Support systems such as heating, ventilation, water
(such as purified or distilled) steam and compressed
air should function as designed and identifiable.

MAINTENANCE
 Weighing, measuring, testing and recording
equipment should be serviced and calibrated
regularly. All records should be maintained.
 SANITATION AND HYGIENE
Sanitation and hygiene should be practiced to avoid
contamination of the manufacturing of products.
 Personnel must practice good personal hygiene.
 It should cover personnel, premises,
equipment/apparatus and production materials and
containers.

CONT……..
 Direct physical contact with the product should be
avoided to ensure protection of the product from
contamination.
 Personnel should wear protective and clean attire
appropriate to the duties they perform.
 All authorized personnel entering the production
areas should practice personal hygiene including
proper attire.
 EQUIPMENT AND APPARATUS
 Equipment and utensils should be kept clean.

 Compressed air and brushes should be used with care and

avoided if possible, as they increase the risk of product

contamination.

 Standard operating procedures must be followed for cleaning

and sanitizing of major machines.

 VERIFICATION OF MATERIALS
 All deliveries of raw materials and packaging materials should
be checked and verified for their conformity to specifications
and be traceable to the product.
 Samples of raw materials should be physically checked for
conformity to specifications prior to release for use.
 The raw materials should be clearly labeled. All goods must be
clean and checked for appropriate protective packing to ensure
no leakage, perforation or exposure.
 REJECTED MATERIALS
Deliveries of raw materials that do not comply with
specification should be segregated and disposed
according to standard operating procedures.
 BATCH NUMBERING SYSTEM
 Every finished product should bear a production identification
number which enables the history of the product to be traced.
 A batch numbering system should be specific for the product and
a particular batch number should not be repeated for the same
product in order to avoid confusion.
 Whenever possible, the batch number should be printed on the
immediate and outer container of the product.
 Records of batch number should be maintained.
 Each batch number record (BMR) should include
the following:
• Name of product.
• Batch formula.
• Brief manufacturing process.
• Batch or code number.
• Date of the start and finish of
processing and packaging.