EN ISO TR 24475-2013 en Cosmetics - Good Manufacturing Practices - General training document《化妆品 良好生产规范 培训总章程》.pdf

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1、BSI Standards PublicationPD ISO/TR 24475:2010Cosmetics GoodManufacturing Practices General training documentPD CEN ISO/TR 24475:2013PD CEN ISO/TR 24475:2013 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO/TR 24475:2013. It is identical to ISO/TR 24475:2

2、010. It supersedes PD ISO/TR 24475:2010, which is withdrawnThe UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all

3、 the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 81797 7ICS 71.100.70Compliance with a British Standard cannot confer immunity from legal obligations.This British

4、Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2010.Amendments/corrigenda issued since publicationDate Text affected30 September 2013 This corrigendum renumbers PD ISO/TR 24475:2010 as PD CEN ISO/TR 24475:2013TECHNICAL REPORT RAPPORT TECHNIQUE

5、TECHNISCHER BERICHT CEN ISO/TR 24475 September 2013 ICS 71.100.70 English Version Cosmetics - Good Manufacturing Practices - General training document (ISO/TR 24475:2010) Cosmtiques - Bonnes pratiques de fabrication - Document gnral de formation (ISO/TR 24475:2010) Kosmetik - Gute Herstellungspraxis

6、 (GHP) - Dokument fr die allgemeine Ausbildung (ISO/TR 24475:2010) This Technical Report was approved by CEN on 29 July 2013. It has been drawn up by the Technical Committee CEN/TC 392. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denm

7、ark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE

8、 FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TR 24475:2013: EPD CEN IS

9、O/TR 24475:2013CEN ISO/TR 24475:2013 (E)CEN ISO/TR 24475:2013 (E) 3 Foreword The text of ISO/TR 24475:2010 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TR 24475:2013 by Technical Committ

10、ee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Endorsement notic

11、e The text of ISO/TR 24475:2010 has been approved by CEN as CEN ISO/TR 24475:2013 without any modification. PD ISO/TR 24475:2010ISO/TR 24475:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Personnel concerned1 3 Content .1 3.1 Preliminary recommendations.1

12、 3.2 General considerations.2 3.3 Quality considerations3 3.4 The activities of Good Manufacturing Practices4 4 Conclusion .12 Bibliography13 PD ISO/TR 24475:2010ISO/TR 24475:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword ivIntroduction.v1 Scope2 Personnel concerned3 Content .1 3.1 P

13、reliminary recommendations.1 3.2 General considerations.2 3.3 Quality considerations3 3.4 The activities of Good Manufacturing Practices44 Conclusion .12Bibliography13 ISO 2010 All rights reservedPD CEN ISO/TR 24475:2013ISO/TR 24475:2010(E)vviPD ISO/TR 24475:2010ISO/TR 24475:2010(E) ISO 2010 All rig

14、hts reserved vIntroduction ISO 22716 was published in 2007. It is aimed at: guiding companies with regard to their manner of organizing and conducting the activities of a plant, so as to control the factors which may affect the quality of cosmetic products; reaching a common and harmonized perceptio

15、n between companies and authorities throughout the world; placing at their disposal a reference document which is recognised by everyone and consistent with the needs of globilzation of the markets. This Technical Report has an educational purpose; it is aimed at encouraging a clearer understanding

16、of the training needs of ISO 22716 within the context of the practical introduction of Good Manufacturing Practices. This Technical Report can be complemented by tools such as CD-ROMs illustrating Good Manufacturing Practices in the cosmetic field, which can be developed in each country/region and e

17、ach company showing examples of practical scenarios, but under no circumstances can these be taken as recommendations or requirements. PD CEN ISO/TR 24475:2013ISO/TR 24475:2010(E) ISO 2010 All rights reservedviPD ISO/TR 24475:2010TECHNICAL REPORT ISO/TR 24475:2010(E) ISO 2010 All rights reserved 1Co

18、smetics Good Manufacturing Practices General training document 1 Scope This Technical Report is aimed at contributing to the training of personnel in cosmetic production plants within the context of the introduction of Good Manufacturing Practices and therefore does not introduce additional requirem

19、ents to ISO 22716. It is intended to complement personal involvement and reasoning in the implementation of ISO 22716. This Technical Report covers the quality aspects of the cosmetic product, but does not take into account safety aspects for the personnel, nor does it cover aspects of protection of

20、 the environment or those concerning the safety and efficacy of the finished products. WARNING This Technical Report cannot be used alone and needs as a prerequisite a good knowledge of ISO 22716 which is the reference document. 2 Personnel concerned This Technical Report is intended for any manager

21、ial and non-managerial personnel, directly involved in the production, control, storage and shipment of cosmetic products in the plant manufacturing, packaging, engineering, technical department, maintenance, receipt of the raw materials and packaging materials, storage, shipments, quality (Quality

22、assurance, quality control laboratories, ) but also purchasing, logistics, administration, finance, management, human resources, cleaning personnel (contract acceptors of cleaning personnel included). Temporary staff should also be taken into account in this general training. 3 Content 3.1 Prelimina

23、ry recommendations ISO 22716 subdivides the Good Manufacturing Practices into 15 key activities which cannot be considered separately. Therefore, in order to facilitate the integration and the educational approach of these Good Manufacturing Practices, it is recommended to tackle them according to t

24、he following three major topics. Quality, comprised of: quality principles; quality control; quality assurance and GMP. PD CEN ISO/TR 24475:2013PD ISO/TR 24475:2010ISO/TR 24475:2010(E) 2 ISO 2010 All rights reserved Justification for the existence of Good Manufacturing Practices (common data): risks

25、 inherent to the production of cosmetic products; elements common to the activities (personnel, premises, equipment, raw materials and packaging materials, documentation). Justification for the existence of Good Manufacturing Practices (specific data); receipt and storage of the raw materials and pa

26、ckaging materials, sampling, release, manufacturing operations, packaging operations, quality control laboratory, storage and shipment of the finished products, out of specification products, wastes, subcontracting, change control, deviations, returns, complaints and recalls, document management, in

27、ternal audit. IMPORTANT The content of the following paragraphs can be used for the training of personnel for example in presentations, courses, etc. 3.2 General considerations The cosmetic industry is becoming increasingly complex due to the fact that the products face worldwide consumer demands an

28、d global competitiveness, which generate an obligation to meet international quality requirements. As a consequence: the products are more and more complex and diverse; the technology implemented is becoming more sophisticated; the procedures tend to become more complicated; the economic burdens bec

29、ome greater. Thus, the quality in producing the products becomes a key point of their success in the market. It is also important to consider that the production process of cosmetic products corresponds to a complex chain where several people are involved and several processes are implemented. In th

30、is context, the cosmetic companies look out for any potential problem and risk that can occur during the production process of their products: the risk of confusion that can result from the simultaneous handling of many raw materials, packaging materials, bulk products and finished products; the ris

31、k of errors that can result from the number of ingredients and components introduced during the formulation of the products; the risk of contamination, that can result from numerous movements involving the flow of persons, materials and products; the risk of deterioration that can result from the im

32、proper handling and transfers of materials and products; the risks resulting from all other types of handling errors, for example a poorly tightened seal after a maintenance operation or poor sealing of a container of raw materials after weighing; the risk in the management of returned products. PD

33、CEN ISO/TR 24475:2013ISO/TR 24475:2010(E)PD ISO/TR 24475:2010ISO/TR 24475:2010(E) ISO 2010 All rights reserved 3The risks mentioned above might also have a long-term impact on the cosmetic production site and on the brand, in terms of image and finances, not to mention the health and legal perspecti

34、ves. All these considerations underline the need to implement a prevention policy shared by all and taking into account the management of all foreseeable potential risks. The implementation of the activities described in the Good Manufacturing Practices can significantly reduce such potential risks.

35、 3.3 Quality considerations 3.3.1 Quality principles In the area of cosmetic products, the quality is defined as a set of characteristics, visible and non-visible, established by the researchers and the development laboratories and able to be reproduced consistently. This clearly defines in advance

36、the characteristics which should correspond to the general requirements and specific needs according to the market sector. 3.3.2 Quality control See 2.13 and 9.1.2 of ISO 22716:2007. In ISO 22716, the quality control laboratory is responsible for verifying that the quality fulfills the required acce

37、pted defined criteria. But such controls alone cannot guarantee the quality of the production process. This is why it remains necessary to rely on the processes implemented by the manufacturer, according to the procedures performed by trained personnel, based on Good Manufacturing Practices for cosm

38、etic products, in order to guarantee that what is done is done well and that what will be done tomorrow will be identical to what is done today. 3.3.3 Quality assurance and GMP See Introduction and 2.27 of ISO 22716:2007. Quality assurance is defined as the set of necessary pre-established and syste

39、matic activities put in place to provide confidence that the products satisfy the accepted defined criteria. GMPs constitute the practical development of the quality assurance concept, to reduce the risks, their occurrence and to manage problems that can occur while making sure that they do not re-o

40、ccur. 3.3.4 The risks inherent to the production of cosmetic products Even when all possible precautions are taken, every activity can still generate quality defects. Some examples can be considered to illustrate deficiencies that may occur during the production process: referring to confusion: unti

41、diness, non-observance of a product nomenclature, failure to follow labelling rules, incorrect separation of flows, improper assignment of tasks to workers, all leading to the risk of confusion, etc.; referring to omissions: forgetting a raw material, forgetting a stage in a procedure, forgetting to

42、 note something down, etc.; referring to contamination: presence in the product of undesirable chemical elements, hair left uncovered near a vessel, sneezing over an open container of raw material, handling with dirty hands, leaving outside doors and windows open, eating near open/uncovered containe

43、rs, etc.; referring to deterioration: poor storage or transport conditions, lack of maintenance of a piece of equipment, etc.; PD CEN ISO/TR 24475:2013ISO/TR 24475:2010(E)PD ISO/TR 24475:2010ISO/TR 24475:2010(E) 4 ISO 2010 All rights reserved referring to improper implementation of procedures, etc.;

44、 many other kinds of error may occur: poorly performed crimping control, erroneous choice of equipment or of raw material, etc. All of these risks impact on the quality of the products with a strong negative repercussion for the brands image. 3.4 The activities of Good Manufacturing Practices 3.4.1

45、Personnel See Clause 3 of ISO 22716:2007. The personnel represent a permanent source of potential errors and contaminations and therefore need to have undergone appropriate training in accordance with their level of responsibility. Such training has to be adapted to the level of experience acquired

46、and therefore should be regularly updated, evaluated and documented. The training programme should be complemented by the hygiene programme. Personnel health should form part of the training programme thereby ensuring that personnel that are ill or have open lesions do not knowingly come into contac

47、t with the product. Visitors and untrained personnel should be given information in advance before they are allowed to enter production, control and storage areas. Together with experience, training is the key to the skills: however, one cannot learn solely through experience, as the knowledge acqui

48、red through training helps to understand the reason for rules, to perfect the “how to do” and, lastly, to take initiatives more successfully to improve quality. The implementation of GMPs remains the responsibility of the management, but their application requires the permanent participation and inv

49、olvement of the personnel from all departments and at all levels. 3.4.2 Premises See Clause 4 of ISO 22716:2007. The premises should be designed or adapted to protect the product from contamination, whether of microbial, physical or chemical origin. The premises should be designed to prevent the intrusion of pests, such as insects, birds, rodents and others. A programme to protect the premises against such pests should be implemented. For example it could consist of laying rodent