1、BRITISH STANDARDBS ISO 22716:2007Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufacturing PracticesICS 71.100.70 BS EN ISO Incorporating corrigendum July 2014BS EN ISO 22716:2007ISBN 978 0 580 71656 0Amendments/corrigenda issued since publicationDate Comments31 July 2014 This co
2、rrigendum renumbers BS ISO 22716:2007 as BS EN ISO 22716:2007It also implements CEN Correction Notice 12 March 2014 and ISO corrected text 15 May 2008: Subclauses 3.2.1.1 and 11.2 updatedThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 Dece
3、mber 2007 The British Standards Institution 2014. Published by BSI Standards Limited 2014National forewordThis British Standard is the UK implementation of EN ISO 22716:2007. It supersedes BS ISO 22716:2007, which is withdrawn.The UK participation in its preparation was entrusted to Technical Commit
4、tee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot
5、confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22716 November 2007 ICS 71.100.70 English Version Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007, Corrected version 2008-05-15) Cosmtiques - Bo
6、nnes pratiques de fabrication (BPF) - Lignes directrices relatives aux bonnes pratiques de fabrication (ISO 22716:2007) Kosmetik - Gute Herstellungspraxis (GMP) - Leitfaden zur guten Herstellungspraxis (ISO 22716:2007) This European Standard was approved by CEN on 16 September 2007. CEN members are
7、bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to th
8、e CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Cent
9、re has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani
10、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-100
11、0 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22716:2007 EEN ISO 22716:2007 (E) 3 Foreword This document (EN ISO 22716:2007, Corrected version 2008-05-15) has been prepared by Technical Committee ISO/TC 217 “C
12、osmetics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2008, and conflicting nati
13、onal standards shall be withdrawn at the latest by May 2008. 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. According to the CEN/CENE
14、LEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemb
15、ourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 22716:2007, Corrected version 2008-05-15 has been approved by CEN as a EN ISO 22716:2007 without any modification. BS EN ISO 22716:20
16、07EN ISO 22716:2007(E)ISO 22716:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Terms and definitions .1 3 Personnel4 4 Premises .6 5 Equipment 8 6 Raw materials and packaging materials .10 7 Production 11 8 Finished products14 9 Quality control laborator
17、y.15 10 Treatment of product that is out of specification.17 11 Wastes 17 12 Subcontracting.18 13 Deviations.19 14 Complaints and recalls .19 15 Change control.19 16 Internal audit 20 17 Documentation.20 BS EN ISO 22716:2007ISO 22716:2007(E) iv ISO 2007 All rights reservedForeword ISO (the Internati
18、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
19、 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
20、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
21、voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to 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
22、such patent rights. ISO 22716 was prepared by Technical Committee ISO/TC 217, Cosmetics. This corrected version contains, for the sake of clarity, syntactical changes to subclauses 3.2.1.1 and 11.2. BS EN ISO 22716:2007ISO 22716:2007(E) ISO 2007 All rights reserved vIntroduction These guidelines are
23、 intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the manage
24、ment of the human, technical and administrative factors affecting product quality. These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a principle is added
25、 to each major section. Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activit
26、ies that enable you to obtain a product that meets defined characteristics. Documentation is an integral part of Good Manufacturing Practices. BS EN ISO 22716:2007blankINTERNATIONAL STANDARD ISO 22716:2007(E) ISO 2007 All rights reserved 1Cosmetics Good Manufacturing Practices (GMP) Guidelines on Go
27、od Manufacturing Practices 1 Scope This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do
28、 they cover aspects of protection of the environment. Safety and environmental aspects are inherent responsibilities of the company and could be governed by local legislation and regulation. These guidelines are not applicable to research and development activities and distribution of finished produ
29、cts. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 acceptance criteria numerical limits, ranges, or other suitable measures for acceptance of test results 2.2 audit systematic and independent examination to determine whether quality activit
30、ies and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives 2.3 batch defined quantity of raw material, packaging material or product issued from one process or series of processes so that it could be e
31、xpected to be homogeneous 2.4 batch number distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch 2.5 bulk product any product which has completed manufacturing stages up to, but not including, final packaging 2.6 calibration set of operations that establis
32、h, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard BS EN ISO 22716:2007ISO 22716:2007(E) 2 ISO 2007 All rights reserved2.7 chan
33、ge control internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond to the defined acceptance criteria 2.8 clean
34、ing all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action, mechanical action, temperature, duration of application 2
35、.9 complaint external information claiming a product does not meet defined acceptance criteria 2.10 contamination occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product 2.11 consumables materials such as cleaning agents and lubricants that are us
36、ed up during cleaning, sanitization or maintenance operations 2.12 contract acceptor person, company or external organization carrying out an operation on behalf of another person, company or organization 2.13 control verification that acceptance criteria are met 2.14 deviation internal organization
37、 and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices 2.15 finished product cosmetic product that has undergone al
38、l stages of production, including packaging in its final container, for shipment 2.16 in-process control controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria 2.17 internal audit systematic
39、 and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving
40、objectives BS EN ISO 22716:2007ISO 22716:2007(E) ISO 2007 All rights reserved 32.18 major equipment equipment specified in production and laboratory documents which is considered essential to the process 2.19 maintenance any periodic or unplanned support and verification operations designed to keep
41、premises and equipment in proper working condition 2.20 manufacturing operation set of operations from the weighing of raw materials to the making of the bulk product 2.21 out-of-specification examination, measurement or test result that does not comply with defined acceptance criteria 2.22 packagin
42、g operation all packaging steps including filling and labelling, which a bulk product has to undergo in order to become a finished product 2.23 packaging material any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation NOTE Packaging materi
43、als are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. 2.24 plant location for production of cosmetic products 2.25 premises physical location, buildings and supporting structures used to conduct receipt, storage, manufactu
44、ring, packaging, control and shipment of product, raw materials and packaging materials 2.26 production manufacturing and packaging operations 2.27 quality assurance all those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria 2.28 ra
45、w material any substance going into or involved in the manufacturing of a bulk product 2.29 recall decision made by a company to call back a product batch that has been put on the market BS EN ISO 22716:2007ISO 22716:2007(E) 4 ISO 2007 All rights reserved2.30 reprocessing re-treatment of all or part
46、 of a batch of finished product or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations 2.31 return sending finished cosmetic products which may or may not present a quality defect back to the p
47、lant 2.32 sample one or more representative elements selected from a set to obtain information about that set 2.33 sampling set of operations relating to the taking and preparation of samples 2.34 sanitization operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depen
48、ding on the objectives set NOTE It is the action of reducing generally invisible contaminants from a surface. 2.35 shipment set of operations relative to the preparation of an order and its putting in a transport vehicle 2.36 waste any residue of a production operation, transformation or use, any su
49、bstance, material, product that its holder intends for disposal 3 Personnel 3.1 Principle Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality. 3.2 Organization 3.2.1 Organization chart 3.2.1.1 The organizational structure should be defined such that the organization and functioning
