ASEAN Cosmetic Documents

Appendix VI – ASEAN Guidelines for Cosmetic Good Manufacturing Practice

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APPENDIX VI

ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE

PREAMBLE

The GMP Guidelines have been produced to offer assistance to the cosmetic industry in
compliance with the provisions of the ASEAN Cosmetic Directive. As this document is particularly
intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP
should be kept in mind.

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.

1. 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.

1.1 General Consideration

1.1.1 In the manufacture of cosmetic products, overall control and monitoring

is essential to ensure that the consumer receives products of specified
quality.

1.1.2 The quality of a product depends on the starting materials, production

and quality control processes, building, equipment and personnel
involved.

1.2 Quality Management System

1.2.1 A quality system should be developed, established and implemented as

a means by which stated policies and objectives will be achieved. It
should define the organisational structure, functions, responsibilities,
procedures, instructions, processes and resources for implementing the
quality management.

1.2.2 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.

1.2.3 The quality system operation should ensure that if necessary, samples of
starting materials, intermediate, and finished products are taken, tested

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to determine their release or rejection on the basis of test results and

other available evidence related to quality.

2. 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.

2.1 Organisation, Qualification and Responsibilities

2.1.1 The organisational 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.

2.1.2 The head of production should be adequately trained and experienced in

cosmetic manufacturing.

He should have authority and responsibilities to manage production of

products covering operations, equipment, production personnel,
production areas and records.

2.1.3 The head of quality control should be adequately trained and

experienced in the field of quality control. He should be given full
authority and responsibility in all quality control duties such as
establishment, verification and implementation of all quality control
procedures. He 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 specification or which were not
manufactured in accordance with approved procedures and under the
defined conditions.

2.1.4 The responsibilities and authority of key personnel should be clearly

defined.

2.1.5 An adequate number of trained personnel should be appointed to

execute direct supervision in each section of the production and the
quality control unit.

2.2 Training

2.2.1 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

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working with any hazardous materials

2.2.2 Training in GMP should be conducted on a continuous basis.

2.2.3 Records of training should be maintained and its effectiveness assessed

periodically.

3. PREMISES

The premises for manufacturing should be suitably located, designed, constructed and
maintained.

3.1 Effective measures should be taken to avoid any contamination from the
surrounding environment and from pests.

3.2 Household products containing non-hazardous materials/ingredients and

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.

3.3 Painted line, plastic curtain and flexible barrier in the form of rope or tape may be
employed to prevent mix-up.

3.4 Appropriate changing rooms and facilities should be provided. Toilets should be
separated fromthe production areas to prevent product contamination/cross
contamination.

3.5 Defined areas should be provided for, wherever possible and applicable:

3.5.1 Materials receiving.

3.5.2 Material Sampling

3.5.3 Incoming goods and quarantine.

3.5.4 Starting materials storage.

3.5.5 Weighing and dispensing.

3.5.6 Processing.

3.5.7 Storage of bulk products.

3.5.8 Packaging.

3.5.9 Quarantine storage before final release of products.

3.5.10 Storage of finished products.

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3.5.11 Loading and unloading.

3.5.12 Laboratories.

3.5.13 Equipment washing.

3.6 Wall and ceiling, where applicable should be smoothand easy to maintain. The
floor in processing areas should have a surface that is easy to clean and sanitise.

3.7 Drains should be of adequate size and should have trapped gullies and proper
flow. Open channels should be avoided where possible, but if required they
should be able to facilitate cleaning and disinfection.

3.8 Air intakes and exhausts and associated pipework and ducting, when applicable,
should be installed in such a way as to avoid product contamination.

3.9 Buildings should be adequately lit and properly ventilated appropriate to the
operations. .

3.10 Pipework, light fittings, ventilation points and other services in manufacturing
areas should preferably be installed in such a way as to avoid uncleanable
recesses and run outside the processing areas.

3.11 Laboratories should preferably be physically separated from the production

areas.

3.12 Storage areas should be of adequate space provided with suitable lighting,
arranged and equipped to allow dry, clean and orderly placement of stored
materials and products.

3.12.1 Such areas should be suitable for effective separation of quarantined

materials and products. Special and segregated areas should be
available for storage of flammable and explosive substances, highly
toxic substances, rejected and recalled materials or returned goods.

3.12.2 Where special storage conditions e.g. temperature, humidity and

security are required, these should be provided.

3.12.3 Storage arrangements should permit separation of different labels

and other printed materials to avoid mix-up.

4. EQUIPMENT

Equipment should be designed and located to suit the production of the product.

4.1 Design and Construction

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4.1.1 The equipment surfaces coming into contact with any in-process
material should not react with or adsorb the materials being
processed.

4.1.2 Equipment should not adversely affect the product through leaking
valves, lubricant drips and through inappropriate modifications or
adaptations.

4.1.3 Equipment should be easily cleaned.

4.1.4 Equipment used for flammable substances should be explosion

proof.

4.2 Installation and Location

4.2.1 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.

4.2.2 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.

4.2.3 Support systems such as heating, ventilation, air conditioning, water

(such as potable, purified, distilled), steam, compressed air and
gases (example nitrogen) should function as designed and
identifiable.

4.3 Maintenance

Weighing, measuring, testing and recording equipment should be serviced and

calibrated regularly. All records should be maintained.

5. SANITATION AND HYGIENE

Sanitation and hygiene should be practised to avoid contamination of the manufacturing

of products. It should cover personnel, premises, equipment/apparatus and production
materials and containers.

5.1 Personnel

5.1.1 Personnel should be healthy to perform their assigned duties.

Regular medical examination must be conducted for all production
personnel involved with manufacturing processes.

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5.1.2 Personnel must practise good personal hygiene..

5.1.3 Any personnel shown at any time to have an apparent illness or

open lesions that may adversely affect the quality of products should
not be allowed to handle raw materials, packaging materials, in-
process materials, and finished products.

5.1.4 Personnel should be instructed and encouraged to report to their

immediate supervisor any conditions (plant, equipment or personnel)
that they consider may adversely affect the products.

5.1.5 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,.

5.1.6 Smoking, eating, drinking and chewing, , food, drinks and smoking
materials and other materials that might contaminate are not
permitted in production, laboratory, storage or other areas where
they might adversely affect product quality.

5.1.7 All authorised personnel entering the production areas should

practice personal hygiene including proper attire.

5.2 Premises

5.2.1 Adequate employee's washing and well ventilated toilet facilities

should be provided and separated from the production area.

5.2.2 Suitable locker facilities should be provided at appropriate location

for the storage of employees' clothing and personal belongings.

5.2.3 Waste material should be regularly collected in suitable receptacles

for removal to collection points outside the production area.

5.2.4 Rodenticides, insecticides, fumigating agents and sanitising

materials must not contaminate equipment, raw materials,
packaging materials, in-process materials or finished products.

5.3 Equipment and Apparatus

5.3.1 Equipment and utensils should be kept clean.

5.3.2 Vacuum or wet cleaning methods are preferred. Compressed air

and brushes should be used with care and avoided if possible, as
they increase the risk of product contamination.

5.3.3 Standard operating procedures must be followed for cleaning and

sanitising of major machines.

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6. PRODUCTION

6.1 Starting Materials

6.1.1 Water

Special attention should be paid to water, since it is an important raw

[Link] production equipment and water systems should supply
quality water. Water systems should be sanitized according to well-
established procedures.

The chemical and microbiological quality of water used in production

should be monitored regularly, according to written procedures and any
anomaly should be followed by corrective action.

The choice of method for water treatment such as deionisation,

distillation or filtration depends on product requirement. The storage as
well as delivery system should be properly maintained.

6.1.2 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 labelled. All goods must be clean and checked for appropriate
protective packing to ensure no leakage, perforation or exposure.

6.1.3 Rejected materials

Deliveries of raw materials that do not comply with specification should

be segregated and disposed according to standard operating
procedures.

6.2 Batch Numbering System

6.2.1 Every finished product should bear a production identification

number which enables the history of the product to be traced..

6.2.2 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.

6.2.3 Whenever possible, the batch number should be printed on the

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immediate and outer container of the product.

6.2.4 Records of batch number should be maintained.

6.3 Weighing and Measurement

6.3.1 Weighing should be carried out in the defined areas using calibrated
equipment.

6.3.2 All weighing and measurement carried out should be recorded and ,
where applicable, counterchecked.

6.4 Procedure and Processing

6.4.1 All starting materials used should be approved according to

specifications.

6.4.2 All manufacturing procedures should be carried out according to

written procedures 6.4.3 All required in-process controls should be
carried out and recorded.

6.4.4 Bulk products should be properly labelled until approved by Quality

Control, where applicable.

6.4.5 Particular attention should be paid to problem of cross-contamination

in all stages of processing.

6.5 Dry Products

Handling of dry materials and products should be given special

attention. Where possible, dust-containing production system, central
vacuum system or other suitable methods should be employed.

6.6 Wet Products

6.6.1 Liquids, creams and lotions should be produced in such a way as to

protect the product from microbial and other contamination.

6.6.2 The use of closed systems of production and transfer is

recommended.

6.6.3 Where pipe-lines are used for delivery of ingredients or bulk

products, care should be taken to ensure that the systems are easy
to clean.

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6.7 Labelling and Packaging

6.7.1 Packaging line should be inspected for clearance prior to operation.

Equipment should be clean and functional. All materials and
products from previous packaging operation should have been
removed.

6.7.2 Samples should be taken and checked at random during labelling

and packaging operations.

6.7.3 Each labelling and packaging line should be clearly identified to

avoid mix-up.

6.7.4 Excess labels and packaging materials should be returned to store

and recorded. Any rejected packaging materials should be
disposed off accordingly..

6.8 Finished Product: Quarantine and Delivery to Finished Stock

6.8.1 All finished products should be approved by Quality Control prior to

release.

7. QUALITY CONTROL

7.1 Introduction

Quality control is an essential part of GMP. It provides assurance that cosmetic

products will be of consistent quality appropriate to their intended use.

7.1.1 A quality control system should be established to ensure that

products contain the correct materials of specified quality and
quantity and are manufactured under proper conditions according to
standard operating procedures.

7.1.2 Quality control involves sampling, inspecting and testing of starting

materials, in process, intermediate, bulk, and finished products. It
also includes where applicable, environmental monitoring programs,
review of batch documentation, sample retention program, stability
studies and maintaining correct specifications of materials and
products.

7.2 Reprocessing

7.2.1 The methods of reprocessing should be evaluated to ensure that

they do not affect the quality of the product.

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7.2.2 Additional testing of any finished product which has been reprocessed
should be performed.

7.3 Returned Products

7.3.1 Returned products should be identified and stored separately either

in allocated area or by moveable barrier such as rope or tape.

7.3.2 All returned products should be tested if necessary, in addition to

physical evaluation before being released for distribution.

7.3.3 Returned products which do not comply with the original specification
should be rejected.

7.3.4 Rejected products should be disposed according to appropriate

procedures.

7.3.5 Records of returned products must be maintained.

8. DOCUMENTATION

8.1 Introduction

The documentation system should include the complete history of each batch,
from starting materials to finished products. The system should record executed
activities for maintenance, storage, quality control, primary distribution and other
specific matters related to GMP.

8.1.1 There should be a system for preventing the use of any superseded
document.

8.1.2 If an error is made or detected on a document, it should be corrected

in such a manner that the original entry is not lost and correction is
made close to the original entry, initialled and dated.

8.1.3 Where documents bear instructions they should be clearly written

step by step.

8.1.4 Documents should be dated and authorised.

8.1.5 Documents should be readily available to relevant parties.

8.2 Specifications

All specifications should be approved by authorised personnel.

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8.2.1 Raw and packaging material specifications should include :

(a) Name of material

(b) Description of the material

(c) Testing parameters and acceptance limits

(d) Technical drawings, where applicable.

(e) Special precautions e.g. storage and safety conditions, if

necessary.

8.2.2 Bulk and finished product specifications should include :

(a) Name of product

(b) Description

(c) Physical properties

(d) Chemical assay and/or microbiological assays and their

acceptance limits ; if necessary

(e) Storage conditions and safety precautions, if necessary

8.3 Documents for Production

8.3.1 Master Formula

The Master formula should be available upon request. This document
should contain the following information :

(a) Product name and product code/number.

(b) Intended packaging materials, and storage conditions

(c) List of raw materials used

(d) List of equipment used.

(e) In-process controls with their limits in processing and

packaging, where applicable.

8.3.2 Batch Manufacturing Record ( BMR )

(a) Batch Manufacturing Records should be prepared for each batch

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of product.

(b) Each BMR should include the following :

i. Name of product
ii. Batch formula
iii. Brief manufacturing process
iv. Batch or code number
v. Date of the start and finish of processing and packaging
vi. Identity of individual major equipment and lines or
location used
vii. Records of cleaning of equipment used for processing
as appropriate
viii. In-process control and laboratory results, such as pH
and temperature test records
ix. Packaging line clearance inspection records
x. Any sampling performed during various steps of
processing
xi. Any investigation of specific failure or discrepancies
xii. Results of examinations on packed and labelled
products

8.3.3 Records for Quality Control

(a) Records for each testing, assay result and release or rejection of starting
materials, intermediates, bulk and finished product should be maintained.

(b) These records may include :

i. Date of test
ii. Identification of the material
iii. Supplier name
iv. Date of receipt
v. Original batch number if any
vi. Batch number
vii. Quality control number
viii. Quantity received
ix. Date of sampling
x. Quality control results

9. INTERNAL AUDITS

An internal audit consists of an examination and assessment of all or part of a quality

system with the specific purpose of improving it. An internal audit may be conducted by
outside or independent specialists or a team designated by the management for this
purpose. Such internal audits may also be extended to suppliers and contractors, if
necessary. A report should be made at the completion of each internal audit.

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10. STORAGE

10.1 Storage Areas

10.1.1 Storage areas should be of sufficient capacity to allow orderly

storage of the various categories of materials and products such as
starting and packaging materials, intermediates, bulk and finished
products, products in quarantine, and released, rejected, returned, or
recalled products.

10.1.2 Storage areas should be designed or adapted to ensure good

storage conditions. They should be clean, dry and well-maintained.
Where special storage conditions are required ( temperature and
humidity ) these should be provided, checked and monitored.

10.1.3 Receiving and dispatch bays should protect materials and products
from weather. Reception areas should be designed and equipped
to allow incoming materials to be cleaned if necessary before
storage.

10.1.4 Storage areas for quarantine products should be clearly demarcated.

10.1.5 Wherever possible sampling area for starting materials should be

provided to prevent contamination.

10.1.6 Hazardous materials should be safely and securely stored.

10.2 Stock Handling and Control

10.2.1 Receiving Products

[Link] Upon receipt, each incoming delivery should be checked

against the relevant documentation and physically
verified by label description, type and quantity.

[Link] The consignment should be carefully inspected for

defects and damage. Records should be retained for
each delivery.

10.2.2 Control

[Link] Records should be maintained showing all receipts and

issues of products.

[Link] Issues should observe the principle of stock rotation (first

in - first out).

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[Link] All labels and containers of products should not be

altered, tampered or changed.

11. CONTRACT MANUFACTURING AND ANALYSIS

The conditions of contract manufacturing and analysis should be clearly defined, agreed,
and controlled so as to avoid misunderstandings, which could result in a product or work of
unsatisfactory quality. All aspects of contracted work should be specified to obtain a quality
product conforming to the agreed standards.

There should be a written contract between the principal and the contract manufacturer to
clearly establish the duties and responsibilities of each party.

12. COMPLAINTS

12.1 A person responsible for handling complaints and deciding the measures to
be taken should be designated. If this person is different from the authorised
person, the latter should be made aware of any complaint, investigation or
recall.

12.2 There should be written procedures describing the action to be taken,

including the need to consider a recall, in the case of a complaint involving a
possible product defect.

12.3 Complaints involving product defects should be recorded with all the original
details and investigated.

12.4 If a product defect is discovered or suspected in a batch, consideration

should be given to whether other batches should be checked in order to
determine whether they are also affected. In particular, other batches that
may contain reprocessed product from the defective batch should be
investigated.

12.5 Where necessary, appropriate follow-up action, possibly including product

recall, should be taken after investigation and evaluation of the complaint.

12.6 All the decisions and measures taken as a result of a complaint should be
recorded and referenced to the corresponding batch records.

12.7 Complaint records should be regularly reviewed for an indication of specific

or recurring problems that require attention and might justify the recall of
marketed products.

12.8 The competent authority should be informed if a manufacturer is considering

action following possibly faulty manufacture and product deterioration,which
may lead to serious safety issues.

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13. PRODUCT RECALLS

There should be a system of recall from the market of products known or suspected to be
defective.

13.1 A person responsible for the execution and co-ordination of recalls should be
designated, as well as sufficient personnel, to handle all aspects of recalls
with the appropriate degree of urgency.

13.2 Written procedures for recall should be established and regularly reviewed.
Recall operations should be capable of being initiated promptly.

13.3 The primary distribution records should be readily available to the person(s)
responsible for recalls, and they should contain sufficient information of
distributors.

13.4 The progress of the recall process should be recorded and a final report
issued, including a reconciliation between the delivered and recovered
quantities of the products.

13.5 The effectiveness of the arrangements for recalls should be evaluated from
time to time.

13.6 A written instruction should be established to ensure recalled products are

stored securely in a segregated area while awaiting decision..

14. GLOSSARY

14.1 Batch

A quantity of any cosmetic product produced in a given cycle of manufacture that

is uniform in character and quality.

14.2 Batch Number

A designation in numbers and/or letters or combination of both that identifies the

complete history of the batch, quality control and distribution.

14.3 Bulk Product

Any processed product which will have to undergo the packaging operation in
order to become a finished product.

14.4 Calibration

Combination of checking an instrument and adjusting it to bring it within its

limits for accuracy according to recognized standards.

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14.5 Date of Manufacture

Date of manufacturing of a batch of product.

14.6 Documentation

All written procedures, instructions and records involved in the manufacture and
quality control of products.

14.7 Product

Any substance or preparation intended to be used, or capable or purported or

claimed to be capable of being used, in or for cleansing, improving, altering or
beautifying the complexion, skin, hair or teeth.

14.8 Finished Product

A product which has undergone all stages of manufacturing operations.

14.9 In-Process Control

Checks and tests instituted and carried out in the course of the manufacture of a
product including checks and tests done on environment and equipment in order
to ensure that the end product will comply with its specification.

14.10 Intermediate Product

Any processed substance or mixture of substances which has to undergo one or

more stages of processing to become a bulk product.

14.11 Manufacture or Manufacturing

The complete set of activities to produce a product, comprising of production and

quality control, from acquisition of all raw materials through processing and
subsequent packaging and release for distribution of the finished product.

14.12 Packaging

The part of production cycle applied to a bulk product to obtain the finished
product.

14.13 Packaging Material

Any material used in the packaging of a bulk product to obtain the finished
product.

14.14 Processing

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The part of production cycle starting from weighing of raw materials to obtaining
a bulk product.

14.15 Production

All operations starting from processing to packaging to obtain a finished product.

14.16 Quality Control

All measures taken during manufacturing which are designed to ensure the
uniform output of product that will conform to established specifications.

14.17 Quarantine

The status of materials or products set apart physically or by system, while

awaiting a decision for their rejection or release for processing, packaging or
distribution.

14.18 Raw Materials

Any ingredient to be used in the formulation of a cosmetic product.

14.19 Rejected

The status of materials or products which are not permitted to be used for
processing, packaging or distribution.

14.20 Released

The status of materials or products which are allowed to be used for processing,
packaging or distribution.

14.21 Returned Product

Finished products sent back to the manufacturer.

14.22 Sanitation

Hygienic control on manufacturing premises, personnel, equipment and material

handling.

14.23 Specification of Materials

A description of a starting material or finished product in terms of its chemical,

physical and biological characteristics, if applicable. A specification normally
includes descriptive and numerical clauses stating standards and tolerated
deviations.

14.24 Starting Materials

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Raw materials and packaging materials used in the production of products.

15. REFERENCES

15.1 Good Manufacturing Practices for Pharmaceutical Products, World Health

Organisation ( WHO ) Technical Report Series No : 823, 1992

15.2 Good Storage Practice, 1st Edition, January 1995, ISBN 983-9870-14-9, National
Pharmaceutical Control Bureau, Malaysia

15.3 Cosmetic Good Manufacturing Practices, COLIPA – The European Cosmetic

Toiletry and Perfumery Association, July 1994

15.4 Australian Code of Good Manufacturing Practice for Therapeutic Goods –

Sunscreen Products, Therapeutic Goods Administration ( TGA ), Australia,
February 1994

15.5 Guidelines on Good Manufacturing Practice ( GMP ) for Traditional Medicines,

National Pharmaceutical Control Bureau, Malaysia, 1st Edition, 1999

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