DECEMBER 2022*

GMP GUIDELINES FOR MANUFACTURERS

OF COSMETIC PRODUCTS

*The latest revision is related to the change in contact details and there is no change in technical requirements.
GMP GUIDELINES FOR MANUFACTURERS OF COSMETIC PRODUCTS DECEMBER 2022

This document is extracted from the 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 product 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.

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1.2.3 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.

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.

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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 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 from the 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 smooth and 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.

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4. EQUIPMENT

Equipment should be designed and located to suit the production of

the product.

4.1 Design and Construction

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.
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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.

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.

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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.

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 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.

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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 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.

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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.

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.

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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.

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.

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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:

(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

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(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.
(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.

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(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.

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.

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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 each
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).

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 contact 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.

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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.

13. PRODUCT RECALLS

There should be a system of recall from the market of products known

or suspected to be defective.

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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.

14.5 Date of Manufacture

Date of manufacturing of a batch of product.

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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
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.

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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 Products

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

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

15. REFERENCES

15.1 ASEAN GUIDELINES FOR COSMETIC GOOD

MANUFACTURING PRACTICE

END OF DOCUMENT

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