Asean

ASEAN Cosmetic Documents
Appendix V – 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 particularl
y intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP sh
ould 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 imp
ortant 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 qualit
y. 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 q
uality.
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 sho
uld define the organisational structure, functions, responsibilities, proced
ures, 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 oth
er 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 c
apable 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 perso
ns, 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, producti
on 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 author
ity and responsibility in all quality control duties such as establishment, v
erification and implementation of all quality control procedures. He sho
uld have the authority to designate/assign when appropriate, personnel,
to approve starting materials, intermediates, bulk and finished products t
hat meet the specification or to reject those which do not conform to the
relevant specification or which were not manufactured in accordance wit
h 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 qual
ity 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 wor
king with any hazardous materials
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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 du
e 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.
3.5.11 Loading and unloading.
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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 sho
uld 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 reces
ses 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 process
ed.
4.1.2 Equipment should not adversely affect the product through leaking
valves, lubricant drips and through inappropriate modifications or ad
aptations.
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 o
r 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 identifiabl
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 p
ersonnel 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-proc
ess 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 permitt
ed 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, packagin
g 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 the
y 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

material.Water production equipment and water systems should supply q
uality water. Water systems should be sanitized according to well-establi
shed procedures.
The chemical and microbiological quality of water used in production

should be monitored regularly, according to written procedures and any a
nomaly 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 tracea
ble 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 pr
otective 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 produc
t in order to avoid confusion.
6.2.3 Whenever possible, the batch number should be printed on the

immediate and outer container of the product.
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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 c
arried 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, centra
l 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 t
o clean.
6.7 Labelling and Packaging
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6.7.1 Packaging line should be inspected for clearance prior to operation.

Equipment should be clean and functional. All materials and product
s 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 dispose
d 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 quanti
ty and are manufactured under proper conditions according to stand
ard 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 s
tudies and maintaining correct specifications of materials and produc
ts.
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.
7.2.2 Additional testing of any finished product which has been reprocessed
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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.
8.2.1 Raw and packaging material specifications should include :
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(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

of product.
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(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
ix. 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 purp
ose. Such internal audits may also be extended to suppliers and contractors, if necessar
y. 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 s
tarting and packaging materials, intermediates, bulk and finished pro
ducts, products in quarantine, and released, rejected, returned, or re
called 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 hu
midity ) 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 t
o 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
10.2.1.1 Upon receipt, each incoming delivery should be checked

against the relevant documentation and physically
verified by label description, type and quantity.
10.2.1.2 The consignment should be carefully inspected for

defects and damage. Records should be retained for ea
ch delivery.
10.2.2 Control
10.2.2.1 Records should be maintained showing all receipts and

issues of products.
10.2.2.2 Issues should observe the principle of stock rotation

(first in - first out).
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10.2.2.3 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 qualit
y 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 re
call.
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 dete
rmine whether they are also affected. In particular, other batches that may c
ontain 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 ma
rketed 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 quant
ities 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 b
eautifying 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
The part of production cycle starting from weighing of raw materials to obtaining
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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 inc
ludes descriptive and numerical clauses stating standards and tolerated deviatio
ns.
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, Febru
ary 1994
15.5 Guidelines on Good Manufacturing Practice ( GMP ) for Traditional Medicines,

National Pharmaceutical Control Bureau, Malaysia, 1st Edition, 1999
18

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ASEAN Cosmetic Documents

Appendix V – ASEAN Guidelines for Cosmetic Good Manufacturing Practice

ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE

The objective of the Cosmetic Good Manufacturing Practice ( GMP ) guidelines is to

1.1 General Consideration

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

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

1.2 Quality Management System

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

There should be an adequate number of personnel having knowledge, experience, skill

2.1 Organisation, Qualification and Responsibilities

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

He should have authority and responsibilities to manage production of

2.1.3 The head of quality control should be adequately trained and

2.1.4 The responsibilities and authority of key personnel should be clearly

2.1.5 An adequate number of trained personnel should be appointed to

2.2.1 All personnel directly involved in the manufacturing activities should be

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

3.2 Household products containing non-hazardous materials/ingredients and

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.

3.5.7 Storage of bulk products.

3.5.9 Quarantine storage before final release of products.

3.5.10 Storage of finished products.

3.5.11 Loading and unloading.

3.5.13 Equipment washing.

3.11 Laboratories should preferably be physically separated from the production

3.12.1 Such areas should be suitable for effective separation of quarantined

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

3.12.3 Storage arrangements should permit separation of different labels

4.1 Design and Construction

4.1.3 Equipment should be easily cleaned.

4.1.4 Equipment used for flammable substances should be explosion

4.2 Installation and Location

4.2.1 Equipment should be located to avoid congestion and should be

4.2.2 Water, steam and pressure or vacuum lines, where applicable,

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

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

5. SANITATION AND HYGIENE

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

5.1.1 Personnel should be healthy to perform their assigned duties.

5.1.2 Personnel must practise good personal hygiene..

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

5.1.4 Personnel should be instructed and encouraged to report to their

5.1.7 All authorised personnel entering the production areas should

5.2.1 Adequate employee's washing and well ventilated toilet facilities

5.2.2 Suitable locker facilities should be provided at appropriate location

5.2.3 Waste material should be regularly collected in suitable receptacles

5.2.4 Rodenticides, insecticides, fumigating agents and sanitising

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

5.3.3 Standard operating procedures must be followed for cleaning and

6.1 Starting Materials

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