COSMETIC

GOOD MANUFACTURING
PRACTICES

Guidelines for the Manufacturer of Cosmetic Producs

July 1994
GENERAL INTRODUCTION 2

I. GLOSSARY 3

II. QUALITY MANAGEMENT SYSTEM 5

II-1. INTRODUCTION 5
II-2. ORGANISATIONAL STRUCTURE AND RESPONSIBILITIES 5
II-3. RESOURCES 6
II-3.1. Personnel 6
II-3.2. Buildings, Equipment and Machinery 6
II-4. PROCEDURES 6
II-5. PROCESSES 6

III. MANUFACTURING 7
III-1. INTRODUCTION 7
III-2. ON-SITE MANUFACTURING 7
III-2.1. Water 7
III 2.2. Materials Receipt 8
III-2.3. Warehousing 8
III-2.4. Processing 8
III-2.4.1. raw materials weighing and dispensing 8
III-2.4.2. compounding 9
III-2.5. Filling and Packing Operations 9
III-2.5.1. preparation 9
III-2.5.2. filling and packing 9
III-2.5.3. distribution 10
III-3. THIRD PARTY MANUFACTURING SUBCONTRACTORS 10
III-3.1. General remarks 10
III-3.2. The Principal 10
III-3.3. The Subcontractor 10
III-3.4. Co-packer Manual 10
III-4. FINISHED PRODUCT RELEASE 11

IV. QUALITY ASSURANCE REQUIREMENTS 11

IV-1. INTRODUCTION 11
IV-2. MANUFACTURING 11
IV-3. PURCHASING AND SUPPLIES 11
IV-4. CONTROL AND MAINTENANCE OF EQUIPMENT AND
PREMISES 12
IV-5. SCALING UP AND MAINTAINING PROCESSES 12
IV-6. INDUSTRIAL HYGIENE 13
IV-7. QUALITY CONTROL OPERATIONS 13
IV-8. TRAINING 14
IV-9. DOCUMENTS 15
IV-9.1. Procedures 15
IV-9.2. Rules of Manufacturing 16
IV-9.3. Specifications 16
IV-9.4. Batch Traceability 16
IV-10. MONITORING AND USE OF RESULTS 17
IV-11. QUALITY AUDIT 17

V. LITERATURE 18

1
GENERAL INTRODUCTION
This document is intended to guide manufacturers of cosmetic products in the way they
organise and carry out the production of cosmetic products, so that human, technical
and administrative factors which may have an influence on the quality of products are
effectively controlled. The aim of this control is to reduce, eliminate and most important
of all, anticipate any deficiency in quality.

Consequently, this guide brings together all the elements to be considered inside each
manufacturing company, so that it can efficiently manufacture cosmetic products, at the
same time ensuring the safety of the user, and conform to its own pre-established
planned standards.

The COSMETIC GOOD MANUFACTURING PRACTICES set out in this guide are
particularly inspired by a total quality management system and are associated with "all
those planned and systematic actions necessary to provide adequate confidence that a
product or service will satisfy given requirements for quality".

This guide has been prepared with specific bias towards the Cosmetic Industry for which
one of the primary objectives is excellence in quality. It is limited to the manufacturing
aspect, after the product has been clearly deemed and elaborated by development. The
guide:
- encourages companies to formalise their quality assurance by proposing an
approach;
- states a number of conditions under which the different stages in the manufacturing
process should be carried out; and
- describes activities which lead to quality assurance.

These COSMETIC GOOD MANUFACTURING PRACTICES are the result of the

experience of an entire profession. They aim at being of general interest and should not
hinder improvement for instance:
- technological developments concerning machinery and processing, packaging and
control equipment;
- progress in manufacturing processes and packing techniques; and
- any evolution in the organisation of production.

It is for each company to adapt these practices to its own specific conditions. It is
accepted that some methods other than those proposed by this guide may be used,
provided that they produce a level of guarantee at least equal to those proposed by the
present recommendations.

Commitment to apply COSMETIC GOOD MANUFACTURING PRACTICES lies with the

senior management of the company; it implies making adequate means available,
particularly in terms of staff, premises and machinery.

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I. GLOSSARY

AUDIT (cf. ISO 8402)

A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are
implemented effusively and art suitable to achieve objectives.
When this examination is carried out by persons outside the company the term ''external
audit'' is used as opposed to ''internal audit'' made by competent personnel inside the
firm.

BATCH
Defined quantity, as far as it can be considered halogenous, of a raw material, a
packaging item, or a product obtained by an operation or series of operations.
In the case of an on-line manufacturing process, a batch may be the quantity produced
within a given period of time.

BATCH NUMBER
A numerical, alphabetical or alpha-numerical reference (or marking) specifically
identifying a batch.

BATCH RECORDS
All documentation related to a well defined amount of manufactured product.

BULK PRODUCT
Product which has gone through all the different stages of manufacturing, excluding
filling into primary packaging.

COMPLAINT
External information claiming a quality defect in a product.

CONPONENTS
Each element or item of packaging material which is necessary to contain the final
product and to ensure mainly its physical protection. Components are referred to as
''primary'' or ''secondary" according to whether or not they come into contact with the
product.

COMPOUNDING
All those operations which allow the prepared raw materials to be combined, according
to a defined process, and which result in bulk product.

FILLING AND PACKING

Set of operations which, starting from bulk products and components, lead to a finished
product.

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FINISHED PRODUCT
Product obtained after the complete manufacturing process; the product which is to be
put on the market.

IDENTIFICATION
Action or set of simple actions (as well as their results) which ensure that during a
manufacturing operation, the proper raw materials and/or the proper components are
used; identification is however no guarantee of quality compliance.

INSPECTION (cf. ISO 8402)

Activities such as measuring, examining, testing, gauging one or more characteristics of
a product or service and comparing these with specified requirements to determine
conformity.

MANUFACTURING
Set of operations of a technical nature (transformation of supplied products, processing,
filling and packing, warehousing, maintenance, checks, inspection...) necessary to
obtain the finished product, as well as any related administrative and economic
operations.

MANUFACTURING INSTRUCTIONS
Documents which describe in detail operations related to a specific product.

PROCEDURE (cf. ISO 8402)

A specified way to perform an activity. This should be accompanied by a relevant
document.

PROCESSING
All operations of a technical nature involved in producing bulk products.

QUALITY ASSURANCE (cf. ISO 8402)

All those planned and systematic actions necessary to provide adequate confidence that
a product or service will satisfy given requirements for quality.

QUALITY CONTROL (cf. ISO 8402)

The operational techniques and activities weigh are used to fulfil requirement for quality.

QUALITY SYSTEM (cf. ISO 8402)

The organisational structure, procedures, processes and resources for implementing
quality management.

RAW MATERIAL
Any substance going into or involved in the processing of a bulk product.

RECALL
Decision taken by a company to call back a product batch which has been put on the
market.

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RETURN
Movement of one or several products which have been put on the market coming back
to the production site.

SAMPLING
Set of operations related to the taking and preparation of samples.

SCHEDULE OF SPECIFICATIONS
A collection of the different specifications and requirements concerning a product, a
piece of equipment or a service laid down by the client for the benefit of the supplier.

SEMI-FINISHED PRODUCT
Product obtained after primary packaging, requiring at least one further operation before
it can be considered as a finished product.

SPECIFICATIONS (cf. ISO 8402)

The documents that describe the requirements to which the product or service has to
conform.

SUBCONTRACTING
Carrying out by an outside person or organisation (the subcontractor) of an operation on
behalf of a person, a company or organisation (the principal).

II. QUALITY MANAGEMENT SYSTEM

II-1. INTRODUCTION

To reach the objectives which a company has set itself, it should design, set up and
maintain a quality system which is adapted to its activities and the nature of its products.
At the production level, this consists of a complete system including organisational
structure, responsibilities, available resources, procedures and processes, in order to
implement quality management.

II-2. ORGANISATIONAL STRUCTURE AND RESPONSIBILITIES

The organisational structure should be clearly defined in order to understand the

organisation and functioning of the company.
Each member of the personnel should know his responsibilities and his own specific
tasks and should be able to find his place in the structure.

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II-3. RESOURCES

The company should be able to rely on adequate and appropriate resources as far as
personnel, premises, equipment and machinery are concerned.

II-3.1. PERSONNEL

Each firm, according to the amount and diversity of its production, should set up an
organisational structure and should employ adequate staff in the different fields of
activity; they should be persons whose knowledge, experience, competence and
motivation are adapted to the tasks and responsibilities which they are given.

II-3.2. BUILDINGS, EQUIPMENT AND MACHINERY

Buildings should be designed, constructed or adapted and maintained in order to satisfy

the conditions dictated by the activities for which they are intended. More particularly
lighting, temperature, humidity and ventilation should not directly or indirectly affect the
quality of products during their manufacture or storage.
Equipment and machinery should be placed so that movement of materials, machinery
and people do not constitute any possible risk to quality. Maintenance of equipment and
machinery should be carried out efficiently so that they are effusively able to serve the
purpose for which they are intended.

II-4. PROCEDURES

Each company should set up its own system of procedures and manufacturing
instructions bearing in mind the nature of its production and the organisational structure
it has decided upon.
Procedures and manufacturing instructions should be suitably defined and formalised;
they describe in detail operations to be carried out, precautions to be taken and
measures to be applied in the different activities connected with production.

II-5. PROCESSES

The processes used in manufacturing should be previously perfected, before any

product is put on the market.
Care should be taken that these processes are implemented in suitably controlled
conditions.

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III. MANUFACTURING

III-1. INTRODUCTION

For each stage of production, measures should be planned and effectively carried out in
order to guarantee that the essential conditions for ensuring conformity are met.

All arrangements should be made for applying and complying with procedures and
instructions relative to each stage of the process. At any given moment it should be
possible to identify a piece of equipment, an instrument, a raw material, a component, a
consumable substance, e.g. cleaning products, or a document.

Any substance other than raw materials and bulk products should not and cannot be
confused with the above in order to avoid contamination.

The company may either carry out all production operations itself (on-site production) or,
for certain operations, resort to subcontracting (off-site production).

Staff should have instructions, information and data for on-line or work-station
operations, for product marking and its nomenclature, for servicing of equipment
(emptying, draining, cleaning, disinfecting...) and for packing operations.

III-2. ON SITE MANUFACTURING

III-2.1. WATER

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

- Water production equipment and water systems should always supply a quality of
water which guarantees conformity of the finished product.
- Water systems should allow disinfection in conformity with well established
procedures.
- Pipework should be built to avoid stagnation and risks of contamination.
- Materials should be chosen so that water quality is not affected.

Suitable markings should allow identification of water pipes such as hot, cold,
demineralised water, cleaning water or steam.

The chemical and microbiological quality of water should be monitored regularly,

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

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III-2.2. MATERIALS RECEIPT

The receipt of all goods intended for profusion (raw materials, components, bulk
products...) should follow an established procedure; each delivery should be recorded
and its conformity carefully checked.

Records should contain information allowing identification of the product. As a guideline

the following information could be:
- the name of the product marked on the delivery note and the containers,
- the name given to the product inside the firm (if it is different from the name given by
the supplier) and/or its code,
- the date of reception,
- the name of the supplier, the batch reference,
- the total quantity and the number of containers received.

The type of verification upon reception of purchased products depends on approval of

the supplier or subcontractor's verification and quality performance system.

Internal identification as well as transport of raw materials, components and other

products should follow established procedures.

Sampling should be taken by authorised and skilled persons in order to guarantee that
the withdrawn samples always correspond to the delivered batch both in identity and
quality.

III-2.3. WAREHOUSING

All materials essential for manufacturing as well as finished goods, should be stored in
proper conditions according to their nature and in an orderly manner to ensure efficient
batch identification and stock rotation. A system should be set up to prevent any
unacceptable material from being used.

If a bulk product is stored, appropriate conditions should be outlined in the procedures.

III-2.4. PROCESSING

III-2.4.1. Raw materials weighing and dispensing

Whatever the organisation on the production site, all raw materials for compounding
should be identified and quantified according to the product formula.

These raw materials should be measured, weighed and proportioned either into clean
adequate recipients containing the necessary information, or directly into the machinery
or equipment for compounding, whether this is done according to a continuous or
discontinuous process. During weighing of raw materials, suitable arrangements should
be made to avoid cross-contamination. After weighing, all raw material containers

8
(external packaging, recipients...) should be placed or replaced to avoid any risk of raw
material alteration.

III-2.4.2. Compounding

All instructions relevant to compounding should be available at the beginning of the

process.

Before compounding, so that machinery is ready for new processing, manufacturing

equipment should be checked to ensure that it is clean and in good working order. It
should be entirely free from any item, element of information or product belonging to any
previous processing.

Each product to be manufactured should be marked (e.g. name, number) so that, at

each stage of the process, each operator is able to find the reference and carry out any
necessary checks.

All compounding requires a formula as well as detailed rules of manufacturing, for each
product, for the batch quantity and for the machinery used.

For instance, rules for compounding should refer to:

- the machinery necessary for manufacture,
- the formula concerned as well as precise marking of the product,
- a list of all raw materials marked according to the rules laid down by the company,
mentioning batch numbers and measured quantities,
- detailed operating rules for each stage: e.g. filling sequences, temperatures, speeds,
mixing times, etc., taking of samples and checks either during or at the end of the
manufacturing process, cleaning machinery, bulk transfer requirements.

If continuous processing is used, instructions should be adapted to this type of

continuous compounding.

III-2.5. FILLING AND PACKING OPERATIONS

III-2.5.1. Preparation

Whatever the organisation for filling and packing, all essential components including bulk
products should be effectively and correctly identified.

III-2.5.2. Filling and packing

Before commencing packing operations, equipment should be inspected to ensure that

the proper machinery is used as planned.

It is also important that there should be no risk of presence or contact of any packaging
component or product from any previous filling or packing operation to avoid any mixing
with the components of tile product to be packed or the product itself.

9
All instructions concerning packing operations, sampling or checks should be available
before commencing the operation.

Products to be packed should be clearly labelled on line or at the work station.

III-2.5.3. Distribution

Procedures for shipping should exist, in order to ensure that conditions necessary for
maintaining product quality are respected.
Before being put on the market, all finished products must conform to standards.

III-3. THIRD PARTY MANUFACTURING: SUBCONTRACTORS

III-3.1. GENERAL REMARKS

Whatever the type of subcontracting, such as partial or total manufacture of a bulk

product, partial or total filling and packing of a product, all subcontracting operations
should be suitably defined, in order to obtain a quality product which conforms to the
standards. To this effect, an agreement should be made between the principal and the
subcontractor to establish each party's liabilities.

III-3.2. THE PRINCIPAL

It is the responsibility of the principal to assess the subcontractor's ability to carry out the
appropriate operations and to ensure that he has the necessary facilities available in his
company (personnel, premises, machinery, quality assurance...). If this is the case, the
principal should provide the subcontractor with all requisite information, for example by
means of a written contract giving details of their respective responsibilities in the
manufacturing stages concerned.

III- 3.3. THE SUBCONTRACTOR

The subcontractor should respect the pre-established formal terms and conditions.
He should pay particular attention to the technical requirements which have been agreed
upon. He should facilitate any checks and audits that the principal may request.

III-3.4. CO-PACKER MANUAL

Procedures and specifications should be drawn up between the principal and the
subcontractor in order to define respective responsibilities for the manufacture of the
product. Technical aspects of specifications should be agreed upon by competent
personnel well trained in Good Manufacturing Practices.

Specifications should make provisions for measures authorising the principal to carry out
audits to ensure that Good Manufacturing Practices are implemented.

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III-4. FINISHED PRODUCT RELEASE

A recognised acceptance act is necessary before finished products are put on the
market, in order to prove their conformity. Different methods for delivering this act are
possible according to the nature of the product, the quality system and the type of
production used.

Products may not be put on the market until effectively released by the principal.
This acceptance must be made following a procedure in clearly defined terms. These
terms may be mentioned in the subcontracting agreement.

IV. QUALITY ASSURANCE REQUIREMENTS

IV-1. INTRODUCTION

Quality assurance during manufacturing involves practically all the company's

operations.

In order to reduce, eliminate and more importantly to preclude any deficiency in quality,
a whole set of activities should be carried out, both by the manufacturing department
itself and by other departments directly or indirectly linked to manufacturing.

IV-2. MANUFACTURING

Involvement of the manufacturing department in quality assurance can be placed under

the following main headings:
• Setting up and respecting procedures and instructions which have been clearly
defined by the competent departments.
• Encouraging manufacturing personnel at all times to report any anomaly and any
incidence of non-conformity.
• Analysing, with the other operations involved, anomalies in quality, followed by
implementation of corrective actions, improvements and monitoring.

IV-3. PURCHASING AND SUPPLIES

Purchasing and supplies is an important element of the quality system of a cosmetic

products company. This activity consists in managing resources which are essential for
manufacturing and which come from outside the company.

It concerns:
- raw materials and components purchased from suppliers, and where applicable
manufacturing machinery,
- partial or total subcontracting of packing operations such as filling,
- partial or total subcontracting of product manufacture, for example by a specialised
company.

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It is essential that all qualitative demands should be specified in close collaboration with
the departments concerned, which could be Research and Developments,
Manufacturing, Quality Assurance.

Responsibilities for the main activities should be clearly deemed, for example:
- setting specifications for raw materials, components, etc.
- approving suppliers and subcontractors for quality assurance,
- setting conditions for customer-supplier relations and exchanges (assistance,
audit,...)
- taking into account inspections carried out by the supplier or the subcontractor,
- drawing up contractual technical clauses (type of inspection to be carried out, criteria
for acceptance or refusal steps to be taken in case of non-conformity or
modifications...),
- any other demands, such as for example, price, delivery times and instructions, or
after-sales service if necessary.

Purchasing documents:

Purchasing documents should contain data describing the product clearly.

Furthermore, a procedure should clearly define the responsibilities concerning the
drawing-up of the order, the type of information or the requirements to be mentioned.

IV-4. CONTROL AND MAINTENANCE OF EQUIPMENT AND PREMISES

Equipment should present no risk of product contamination and/or deterioration.

- Premises should be kept clean and tidy.
- Production machinery should be designed, installed and maintained according to its
purpose and should present no risk to product quality. It should be placed so as to
respect movement and should be cleaned following deemed procedures. All
production machinery should be regularly maintained and kept in good working order
according to set programmes, either by the competent department inside the
company, or by means of a maintenance contract.
- Production areas should not be used by personnel not employed therein.
- Cleaning products should not come into contact with cosmetic products.

Records of every operation carried out on this machinery should be kept according to
local customs or requirement. For weighing apparatus on production machinery, regular
calibration of measurement instruments should be made.

IV-5. SCALING UP AND MAINTAINING PROCESSES

Generally speaking, the department, whether inside or outside the company which has
developed the product (formula and packaging), should also provide at least a pilot
process, taking into consideration these cosmetic GMP requirements.

12
Processing, filling and packing operations should follow well-defined and tested
procedures.

A formalised process should exist according to the nature of the product, the size and
structure of the company, which leads to an industrial process.

It is also important to update validation procedures in the light of new conditions.

Confirmation should be made that the compounding, filling and packing process has
been adequately reproduced and can lead to a product which conforms to the standard.

IV-6. INDUSTRIAL HYGIENE

For the Cosmetic Industry, a finished product should neither adversely affect the health
of the consumer, nor undergo any deterioration in quality due to the presence or
multiplication of micro-organisms in the product. In order to achieve this, it is essential to
comply with good hygiene practices.

As the risk of microbiological contamination is different according to each product, for

example perfumes in comparison to emulsions, the different production stages should
be carried out under conditions of industrial hygiene well adapted to the nature of the
product, in order to prevent any risk of contamination.

In all sectors of the factory, it is essential to keep building, equipment machinery and
instruments, as well as raw materials, components, bulk and finished products in good
hygienic conditions.

Generally speaking, the different activities concerned are the manufacturing area, which
should be organised so as to avoid any risk of standing water, dust in the atmosphere,
presence of insects and other animals. Filling and packing equipment should be cleaned
and disinfected according to their design and use.

The personnel should respect specific practices as far as personal hygiene is concerned
and follow instructions as to how to work and carry out operations.

It is important to identify the source and the nature of any contamination likely to appear
and to take steps to eliminate these sources in order to prevent product contamination.

IV-7. QUALITY CONTROL OPERATIONS

By quality control operations, are meant all operations carried out with a view to
monitoring quality compliance during manufacturing.

Concerning the different operations, we can divide them into two groups:
- First, control of incoming goods and final control of finished products are the
responsibility of laboratory personnel,
- Second, process control during manufacturing is the responsibility of manufacturing
personnel.

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In order to carry out these control operations efficiently, both laboratories and
manufacturing personnel should have available the following information:
- specifications,
- sampling procedures,
- inspection and test methods,
- acceptance limits.

As far as the manufacturing control is concerned, following controls should be carried

out for example:
- identification (internal code number, commercial name...),
- batch number and date,

Results obtained should be endorsed, used and recorded. These records should contain
at least the following data:
- results of inspections, measurement or checks, as well as any remarks by staff
having carried out the operations,
- in the specific case of approving, the situation should be clearly stated: approved,
rejected, pending.

Any type of filling system may be used, on condition that documents can be rapidly
consulted, reproduced and kept in good condition.

Sufficient quantities of raw material samples corresponding to each batch used should
be kept, so that complete analyses can be made; the same conditions apply to each
batch of finished products which should be kept in their packaging. All these identified
samples should be stored in limited access areas which are specifically intended for this
purpose (sample library).

IV-8. TRAINING

To achieve effective quality control in manufacturing, a company should, among other

things, be able to call upon personnel with the necessary knowledge, experience,
competence and motivation. To this effect, it is above all essential to identify the training
needs of personnel at whatever level in the hierarchy and to draw up a staff training
plan.

Bearing in mind the know-how and the experience of a given section of personnel,
training courses adapted to their jobs and responsibilities should be drawn up and
implemented. Consequently, for example complete training is essential for all key
personnel and manufacturing personnel concerning the methods and competence
required to carry out different operations (e.g. weighing, compounding maintenance,
industrial hygiene, manufacturing, in-line checks…).

14
According to the means and resources available inside each company, these training
courses may either be devised by the company itself or with the help of outside
specialised organisations following a programme which should be worked out case by
case.

At all events, this plan should be regularly reviewed and followed up.

IV-9. DOCUMENTS

In order to avoid errors which may arise from spoken communication discrepancies, lack
of precision, forgetfulness, documents are indispensable.

The administration of these documents should follow a procedure indicating particularly:

- the person(s) setting up the documents and endorsing them before distribution
- the person(s) for whom the documents are intended
- the location and system of document archiving

The procedure should clearly define the type of any modifications and the responsible
persons concerned; it should mention the reasons and the date.

All documentation should be regularly revised and updated taking care to withdraw
immediately any out-of-date document. An inventory of documents existing inside the
company should be kept up-to-date.

Different types of documentation should generally deal with procedures, instructions,

specifications and follow-up documents. Documentation should be set up taking into
account the specific nature, organisation and means of each company.

IV-9.1. PROCEDURES

General guidelines for operations to be carried out should be given. For example,
procedures may concern the following:
- sampling of raw materials and components,
- manufacturing processes, filling and packaging methods, inspection methods for
machinery and equipment,
- cleaning and/or disinfecting premises and machinery used during manufacturing,
- actions to be carried out before commencing any production operation, for example
line emptying,
- measures to be taken and methods to be followed due to non-conformity of
components, raw materials, bulk products, finished products…,
- calibration of measuring instruments,
- product recall.

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IV-9.2. RULES OF MANUFACTURING

For proper manufacturing, it is essential that precise rules are defined for all possible
operations.

They should give a detailed description of operations to manufacture a certain product.

Processing, filling and packing rules for each product or group of products should be set
up.

IV-9.3. SPECIFICATIONS

Specifications should describe requirements with which all raw materials, component,
bulk products, semi-finished and finished products used or obtained during manufacture
have to comply.

Specifications should give the following details, for example:

- internal code number or identification adopted by the company,
- qualitative (chemical, physical and microbiological) and quantitative requirements
and their acceptance limits,
- dates of possible re-inspections,
- references of methods used for complying with set requirement.

IV-9.4. BATCH TRACEABILITY

In order to carry out necessary investigations efficiently, within the framework of possible
incidents encountered concerning the quality of a product batch, it is essential to record
the processing and packing data for each batch and to ensure the batch traceability.

These data should also be used in order to improve quality.

Records and monitoring operations should be made at each production stage and
should concern, for example:
- measurements and tests made during manufacturing and packing,
- data given by automated processing and checking equipment,
- remarks and observations made by processing and packing staff during production.

A system of liaison between established documents concerning the different

manufacturing operations, as well as control operations concerning all different
materials, should allow batch traceability.

These documents may either be kept together in one place or left in the different
departments concerned, for consultation.

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IV-10. MONITORING AND USE OF RESULTS

Exploitation of results is an important approach in quality assurance. It enabled, on the

one hand, measuring quality in manufacturing, and on the other hand, monitoring results
of corrective actions which have been carried out.

With the help of this information, an analysis of probable causes for defects should be
made in order to decide on corrective actions to be carried out.

Permanent monitoring of defects which need immediate action, as well as periodic

synthesis of results obtained after actions have been carried out are two essential
elements of a quality system. This is the responsibility of the manufacturing department
and the departments involved in quality assurance.

In case of complaint, only justified complaints will be considered and connected with
batch record. It should be recorded, sent to the departments concerned, an analysis of
the causes made, and if necessary, corrective actions should be carried out.

IV-11. QUALITY AUDIT

Audits should be conducted in an independent and detailed manner, regularly or on

demand, by specially designated competent persons. These audits may take place
either off the production site at suppliers, subcontractors or on site. They should concern
the quality system in general.

The aim of the audits is to ensure conformity with Cosmetic Good Manufacturing
Practices and if necessary to propose corrective actions.

The results of audits should be sent to the management of the company and
communicated to the audited personnel, so that they can take part in setting up actions
for improvement. Checks should be made that corrective action has been taken.

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V. LITERATURE
ISO 8 402
Quality - vocabulary

ISO 9 001
Quality systems - Model for Quality Assurance in design development, production
installation and servicing

ISO 9 004
Quality management and quality system elements – Guidelines

The rules governing medicinal products in the European Community - Guide to Good
Manufacturing Practices for medicinal products - vol. IV ; 1989.

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COLIPA , THE EUROPEAN COSMETIC, TOILETRY AND PERFUMERY
ASSOCIATION, was set up in 1962 under Belgian law with headquarters in Brussels.

Its Membership covers a large number of cosmetic businesses of different sizes

throughout Europe.

The structure of COLIPA is based on a National Associations Council with 12 full

Members and 8 corresponding or associated Members, and an International Companies
Council made up of 22 important companies.

Acting as a central coordinating body, THE EUROPEAN COSMETIC, TOILETRY AND

PERFUMERY ASSOCIATION defends the interests of an industry at the forefront of
innovation which offers consumers high-quality and scientifically validated products.

COLIPA is particularly involved in harmonising legislation amongst the E.C.U.

Member States in the frameworks of the Single Market. It provides a communication

centre for the European cosmetics industry and represents it in relations with
international authorities and organisations, and principally with the Community
institutions.

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