1、 Reference number ISO/TR 24475:2010(E) ISO 2010TECHNICAL REPORT ISO/TR 24475 First edition 2010-03-01 Cosmetics Good Manufacturing Practices General training document Cosmtiques Bonnes pratiques de fabrication Document gnral de formation ISO/TR 24475:2010(E) PDF disclaimer This PDF file may contain
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6、requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedISO/TR 24475:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v
7、 1 Scope1 2 Personnel concerned1 3 Content .1 3.1 Preliminary recommendations.1 3.2 General considerations.2 3.3 Quality considerations3 3.4 The activities of Good Manufacturing Practices4 4 Conclusion .12 Bibliography13 ISO/TR 24475:2010(E) iv ISO 2010 All rights reservedForeword ISO (the Internati
8、onal Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been
9、 established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standa
10、rdization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for
11、voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is normally published as an International Standard (“state of the a
12、rt”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer valid or useful. Attention is drawn t
13、o the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 24475 was prepared by Technical Committee ISO/TC 217, Cosmetics. ISO/TR 24475:2010(E) ISO 2010 All rights reserved
14、 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 perception between co
15、mpanies 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 of the train
16、ing 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 each company
17、showing examples of practical scenarios, but under no circumstances can these be taken as recommendations or requirements. TECHNICAL REPORT ISO/TR 24475:2010(E) ISO 2010 All rights reserved 1Cosmetics Good Manufacturing Practices General training document 1 Scope This Technical Report is aimed at co
18、ntributing 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 requirements to ISO 22716. It is intended to complement personal involvement and reasoning in the implementation of
19、 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 the environment or those concerning the safety and efficacy of the finished products. WARNING This Technic
20、al 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 managerial and non-managerial personnel, directly involved in the production, control, storage and shipment of cos
21、metic products in the plant manufacturing, packaging, engineering, technical department, maintenance, receipt of the raw materials and packaging materials, storage, shipments, quality (Quality assurance, quality control laboratories, ) but also purchasing, logistics, administration, finance, managem
22、ent, 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 Preliminary recommendations ISO 22716 subdivides the Good Manufacturing Practices into 15 key activities which canno
23、t 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 the following three major topics. Quality, comprised of: quality principles; quality control; quality assura
24、nce and GMP. ISO/TR 24475:2010(E) 2 ISO 2010 All rights reserved Justification for the existence of Good Manufacturing Practices (common data): risks inherent to the production of cosmetic products; elements common to the activities (personnel, premises, equipment, raw materials and packaging materi
25、als, documentation). Justification for the existence of Good Manufacturing Practices (specific data); receipt and storage of the raw materials and packaging materials, sampling, release, manufacturing operations, packaging operations, quality control laboratory, storage and shipment of the finished
26、products, out of specification products, wastes, subcontracting, change control, deviations, returns, complaints and recalls, document management, internal audit. IMPORTANT The content of the following paragraphs can be used for the training of personnel for example in presentations, courses, etc. 3
27、.2 General considerations The cosmetic industry is becoming increasingly complex due to the fact that the products face worldwide consumer demands and global competitiveness, which generate an obligation to meet international quality requirements. As a consequence: the products are more and more com
28、plex and diverse; the technology implemented is becoming more sophisticated; the procedures tend to become more complicated; the economic burdens become 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
29、production process of cosmetic products corresponds to a complex chain where several people are involved and several processes are implemented. In this context, the cosmetic companies look out for any potential problem and risk that can occur during the production process of their products: the risk
30、 of confusion that can result from the simultaneous handling of many raw materials, packaging materials, bulk products and finished products; the risk of errors that can result from the number of ingredients and components introduced during the formulation of the products; the risk of contamination,
31、 that can result from numerous movements involving the flow of persons, materials and products; the risk of deterioration that can result from the improper handling and transfers of materials and products; the risks resulting from all other types of handling errors, for example a poorly tightened se
32、al after a maintenance operation or poor sealing of a container of raw materials after weighing; the risk in the management of returned products. ISO/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
33、 brand, in terms of image and finances, not to mention the health and legal perspectives. 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 describ
34、ed in the Good Manufacturing Practices can significantly reduce such potential risks. 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
35、laboratories and able to be reproduced consistently. This clearly defines in advance 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 contro
36、l laboratory is responsible for verifying that the quality fulfills the required accepted 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 proc
37、edures performed by trained personnel, based on Good Manufacturing Practices for cosmetic 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
38、:2007. Quality assurance is defined as the set of necessary pre-established and systematic 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 occ
39、urrence and to manage problems that can occur while making sure that they do not re-occur. 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 de
40、ficiencies that may occur during the production process: referring to confusion: untidiness, 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 o
41、missions: forgetting a raw material, forgetting a stage in a procedure, forgetting to 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 dir
42、ty hands, leaving outside doors and windows open, eating near open/uncovered containers, etc.; referring to deterioration: poor storage or transport conditions, lack of maintenance of a piece of equipment, etc.; ISO/TR 24475:2010(E) 4 ISO 2010 All rights reserved referring to improper implementation
43、 of procedures, etc.; 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 Manufactu
44、ring Practices 3.4.1 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
45、 experience acquired 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 knowi
46、ngly come into contact 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, a
47、s the knowledge acquired 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
48、participation and involvement 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 design
49、ed 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 traps or substances to attract and trap insects inside the premises. Outside the premises, measures should be taken to ensure that pests are not attracted or offered shelter. The premises should also be well ventilated in a manner that does not allow outside contaminants to e
