03 - Good Manufacturing Practices - Guidelines for the Manufacturer of Cosmetic Products

8/3/2019 03 - Good Manufacturing Practices - Guidelines for the Manufacturer of Cosmetic Products

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COSMETICGOOD MANUFACTURINGPRACTICES

Guidelines for the Manufacturer of Cosmetic Producs

July 1994


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GENERAL INTRODUCTION 2

I. GLOSSARY 3

II. QUALITY MANAGEMENT SYSTEM 5II-1. INTRODUCTION 5

II-2. ORGANISATIONAL STRUCTURE AND RESPONSIBILITIES 5II-3. RESOURCES 6

II-3.1. Personnel 6II-3.2. Buildings, Equipment and Machinery 6

II-4. PROCEDURES 6II-5. PROCESSES 6

III. MANUFACTURING 7III-1. INTRODUCTION 7III-2. ON-SITE MANUFACTURING 7

III-2.1. Water 7III 2.2. Materials Receipt 8III-2.3. Warehousing 8

III-2.4. Processing 8III-2.4.1. raw materials weighing and dispensing 8III-2.4.2. compounding 9

III-2.5. Filling and Packing Operations 9III-2.5.1. preparation 9III-2.5.2. filling and packing 9III-2.5.3. distribution 10

III-3. THIRD PARTY MANUFACTURING SUBCONTRACTORS 10III-3.1. General remarks 10III-3.2. The Principal 10III-3.3. The Subcontractor 10III-3.4. Co-packer Manual 10

III-4. FINISHED PRODUCT RELEASE 11

IV. QUALITY ASSURANCE REQUIREMENTS 11IV-1. INTRODUCTION 11IV-2. MANUFACTURING 11IV-3. PURCHASING AND SUPPLIES 11IV-4. CONTROL AND MAINTENANCE OF EQUIPMENT AND

PREMISES 12IV-5. SCALING UP AND MAINTAINING PROCESSES 12IV-6. INDUSTRIAL HYGIENE 13IV-7. QUALITY CONTROL OPERATIONS 13IV-8. TRAINING 14IV-9. DOCUMENTS 15

IV-9.1. Procedures 15IV-9.2. Rules of Manufacturing 16IV-9.3. Specifications 16IV-9.4. Batch Traceability 16

IV-10. MONITORING AND USE OF RESULTS 17IV-11. QUALITY AUDIT 17

V. LITERATURE 18


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GENERAL INTRODUCTION

This document is intended to guide manufacturers of cosmetic products in the way theyorganise and carry out the production of cosmetic products, so that human, technicaland 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 importantof all, anticipate any deficiency in quality.

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

The COSMETIC GOOD MANUFACTURING PRACTICES set out in this guide areparticularly inspired by a total quality management system and are associated with "allthose 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 whichone of the primary objectives is excellence in quality. It is limited to the manufacturingaspect, after the product has been clearly deemed and elaborated by development. Theguide:- 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 theexperience of an entire profession. They aim at being of general interest and should nothinder 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 isaccepted 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 thepresent recommendations.

Commitment to apply COSMETIC GOOD MANUFACTURING PRACTICES lies with thesenior 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 andrelated results comply with planned arrangements and whether these arrangements areimplemented effusively and art suitable to achieve objectives.When this examination is carried out by persons outside the company the term ''externalaudit'' is used as opposed to ''internal audit'' made by competent personnel inside thefirm.

BATCHDefined quantity, as far as it can be considered halogenous, of a raw material, apackaging 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 NUMBERA numerical, alphabetical or alpha-numerical reference (or marking) specificallyidentifying a batch.

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

BULK PRODUCTProduct which has gone through all the different stages of manufacturing, excluding

filling into primary packaging.

COMPLAINTExternal information claiming a quality defect in a product.

CONPONENTSEach element or item of packaging material which is necessary to contain the finalproduct 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 theproduct.

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

FILLING AND PACKINGSet of operations which, starting from bulk products and components, lead to a finishedproduct.


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FINISHED PRODUCTProduct obtained after the complete manufacturing process; the product which is to beput on the market.

IDENTIFICATION

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

INSPECTION (cf. ISO 8402)Activities such as measuring, examining, testing, gauging one or more characteristics ofa product or service and comparing these with specified requirements to determineconformity.

MANUFACTURINGSet of operations of a technical nature (transformation of supplied products, processing,filling and packing, warehousing, maintenance, checks, inspection...) necessary toobtain the finished product, as well as any related administrative and economicoperations.

MANUFACTURINGINSTRUCTIONSDocuments 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 relevantdocument.

PROCESSINGAll 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 thata 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 implementingquality management.

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

RECALLDecision taken by a company to call back a product batch which has been put on themarket.


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RETURNMovement of one or several products which have been put on the market coming backto the production site.

SAMPLING

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

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

SEMI-FINISHED PRODUCTProduct obtained after primary packaging, requiring at least one further operation beforeit can be considered as a finished product.

SPECIFICATIONS (cf. ISO 8402)The documents that describe the requirements to which the product or service has toconform.

SUBCONTRACTINGCarrying out by an outside person or organisation (the subcontractor) of an operation onbehalf 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 andmaintain 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 organisationalstructure, responsibilities, available resources, procedures and processes, in order toimplement quality management.

II-2. ORGANISATIONAL STRUCTURE AND RESPONSIBILITIES

The organisational structure should be clearly defined in order to understand theorganisation and functioning of the company.

Each member of the personnel should know his responsibilities and his own specifictasks 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 aspersonnel, premises, equipment and machinery are concerned.

II-3.1. PERSONNEL

Each firm, according to the amount and diversity of its production, should set up anorganisational structure and should employ adequate staff in the different fields ofactivity; they should be persons whose knowledge, experience, competence andmotivation 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 satisfythe conditions dictated by the activities for which they are intended. More particularlylighting, temperature, humidity and ventilation should not directly or indirectly affect thequality of products during their manufacture or storage.Equipment and machinery should be placed so that movement of materials, machineryand people do not constitute any possible risk to quality. Maintenance of equipment andmachinery should be carried out efficiently so that they are effusively able to serve thepurpose for which they are intended.

II-4. PROCEDURES

Each company should set up its own system of procedures and manufacturinginstructions bearing in mind the nature of its production and the organisational structureit 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 andmeasures to be applied in the different activities connected with production.

II-5. PROCESSES

The processes used in manufacturing should be previously perfected, before anyproduct is put on the market.Care should be taken that these processes are implemented in suitably controlledconditions.


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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 andinstructions relative to each stage of the process. At any given moment it should bepossible to identify a piece of equipment, an instrument, a raw material, a component, aconsumable substance, e.g. cleaning products, or a document.

Any substance other than raw materials and bulk products should not and cannot beconfused 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-stationoperations, 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 ofwater which guarantees conformity of the finished product.

- Water systems should allow disinfection in conformity with well establishedprocedures.

- 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 correctiveaction.


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III-2.2. MATERIALS RECEIPT

The receipt of all goods intended for profusion (raw materials, components, bulkproducts...) 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 guidelinethe 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 ofthe supplier or subcontractor's verification and quality performance system.

Internal identification as well as transport of raw materials, components and otherproducts should follow established procedures.

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

III-2.3. WAREHOUSING

All materials essential for manufacturing as well as finished goods, should be stored inproper conditions according to their nature and in an orderly manner to ensure efficientbatch identification and stock rotation. A system should be set up to prevent anyunacceptable 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 compoundingshould be identified and quantified according to the product formula.

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


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

III-2.4.2. Compounding

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

Before compounding, so that machinery is ready for new processing, manufacturingequipment should be checked to ensure that it is clean and in good working order. Itshould be entirely free from any item, element of information or product belonging to anyprevious processing.

Each product to be manufactured should be marked (e.g. name, number) so that, ateach stage of the process, each operator is able to find the reference and carry out anynecessary checks.

All compounding requires a formula as well as detailed rules of manufacturing, for eachproduct, 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 themanufacturing process, cleaning machinery, bulk transfer requirements.

If continuous processing is used, instructions should be adapted to this type ofcontinuous compounding.

III-2.5. FILLING AND PACKING OPERATIONS

III-2.5.1. Preparation

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

III-2.5.2. Filling and packing

Before commencing packing operations, equipment should be inspected to ensure thatthe proper machinery is used as planned.

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


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All instructions concerning packing operations, sampling or checks should be availablebefore 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 formaintaining 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 bulkproduct, partial or total filling and packing of a product, all subcontracting operationsshould be suitably defined, in order to obtain a quality product which conforms to thestandards. To this effect, an agreement should be made between the principal and thesubcontractor 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 theappropriate operations and to ensure that he has the necessary facilities available in hiscompany (personnel, premises, machinery, quality assurance...). If this is the case, theprincipal should provide the subcontractor with all requisite information, for example bymeans of a written contract giving details of their respective responsibilities in themanufacturing 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 agreedupon. 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 thesubcontractor in order to define respective responsibilities for the manufacture of theproduct. Technical aspects of specifications should be agreed upon by competentpersonnel well trained in Good Manufacturing Practices.

Specifications should make provisions for measures authorising the principal to carry outaudits 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 themarket, 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 ofproduction 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. Theseterms may be mentioned in the subcontracting agreement.

IV. QUALITY ASSURANCE REQUIREMENTS

IV-1. INTRODUCTION

Quality assurance during manufacturing involves practically all the company'soperations.

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 departmentitself and by other departments directly or indirectly linked to manufacturing.

IV-2. MANUFACTURING

Involvement of the manufacturing department in quality assurance can be placed underthe following main headings:

Setting up and respecting procedures and instructions which have been clearlydefined by the competent departments.

Encouraging manufacturing personnel at all times to report any anomaly and anyincidence of non-conformity.

Analysing, with the other operations involved, anomalies in quality, followed byimplementation of corrective actions, improvements and monitoring.

IV-3. PURCHASING AND SUPPLIES

Purchasing and supplies is an important element of the quality system of a cosmeticproducts 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 withthe 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 ormodifications...),

- any other demands, such as for example, price, delivery times and instructions, orafter-sales service if necessary.

Purchasing documents:

Purchasing documents should contain data describing the product clearly.Furthermore, a procedure should clearly define the responsibilities concerning thedrawing-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 torespect movement and should be cleaned following deemed procedures. Allproduction machinery should be regularly maintained and kept in good working orderaccording to set programmes, either by the competent department inside thecompany, 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 tolocal customs or requirement. For weighing apparatus on production machinery, regularcalibration of measurement instruments should be made.

IV-5. SCALING UP AND MAINTAINING PROCESSES

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


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Processing, filling and packing operations should follow well-defined and testedprocedures.

A formalised process should exist according to the nature of the product, the size andstructure 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 hasbeen 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 healthof the consumer, nor undergo any deterioration in quality due to the presence ormultiplication of micro-organisms in the product. In order to achieve this, it is essential tocomply with good hygiene practices.

As the risk of microbiological contamination is different according to each product, forexample perfumes in comparison to emulsions, the different production stages shouldbe carried out under conditions of industrial hygiene well adapted to the nature of theproduct, in order to prevent any risk of contamination.

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

Generally speaking, the different activities concerned are the manufacturing area, whichshould 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 cleanedand disinfected according to their design and use.

The personnel should respect specific practices as far as personal hygiene is concernedand 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 appearand 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 tomonitoring 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 andmanufacturing 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 carriedout for example:- identification (internal code number, commercial name...),- batch number and date,

Results obtained should be endorsed, used and recorded. These records should containat 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 rapidlyconsulted, reproduced and kept in good condition.

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

IV-8. TRAINING

To achieve effective quality control in manufacturing, a company should, among otherthings, 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 trainingneeds of personnel at whatever level in the hierarchy and to draw up a staff trainingplan.

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 andimplemented. Consequently, for example complete training is essential for all keypersonnel and manufacturing personnel concerning the methods and competencerequired to carry out different operations (e.g. weighing, compounding maintenance,industrial hygiene, manufacturing, in-line checks).


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

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, lackof 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 responsiblepersons concerned; it should mention the reasons and the date.

All documentation should be regularly revised and updated taking care to withdrawimmediately any out-of-date document. An inventory of documents existing inside thecompany 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 intoaccount 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 setup.

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 manufacturehave 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 recordthe 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 andshould 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 differentmanufacturing operations, as well as control operations concerning all differentmaterials, should allow batch traceability.

These documents may either be kept together in one place or left in the differentdepartments 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 theone hand, measuring quality in manufacturing, and on the other hand, monitoring resultsof corrective actions which have been carried out.

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

Permanent monitoring of defects which need immediate action, as well as periodicsynthesis of results obtained after actions have been carried out are two essentialelements of a quality system. This is the responsibility of the manufacturing departmentand the departments involved in quality assurance.

In case of complaint, only justified complaints will be considered and connected withbatch record. It should be recorded, sent to the departments concerned, an analysis ofthe 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 ondemand, by specially designated competent persons. These audits may take placeeither off the production site at suppliers, subcontractors or on site. They should concernthe quality system in general.

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

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


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V. LITERATURE

ISO 8 402Quality - vocabulary

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

ISO 9 004Quality management and quality system elements Guidelines

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


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COLIPA , THE EUROPEAN COSMETIC, TOILETRY AND PERFUMERYASSOCIATION, 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 fullMembers and 8 corresponding or associated Members, and an International CompaniesCouncil made up of 22 important companies.

Acting as a central coordinating body, THE EUROPEAN COSMETIC, TOILETRY ANDPERFUMERY ASSOCIATION defends the interests of an industry at the forefront ofinnovation 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 communicationcentre for the European cosmetics industry and represents it in relations withinternational authorities and organisations, and principally with the Communityinstitutions.


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