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1、D A N S K S T A N D A R D Danish Standards Kollegievej 6 DK-2920 Charlottenlund Tel: +45 39 96 61 01 Fax: +45 39 96 61 02 dansk.standardds.dk www.ds.dk All rights of exploitation in any form and by any means reserved worldwide for Danish Standards M212195 OFFENTLIG HRING PUBLIC ENQUIRY DSF/prEN ISO
2、22716 FORSLAGSNR. M212195 DRAFT NO. M212195 Dette forslag til Dansk Standard er p offentlig hring i perioden fra: This draft for Danish Standard is for public enquiry in the period from: 2006-04-11 til 2007-08-14 2006-04-11 to 2007-08-14 Dette forslag bygger p flgende euro- piske/internationale stan
3、dard: This draft is based on European / Inter national draft: prEN ISO 22716 IDT ISO/FDIS 22716 IDT IDT = identisk med/identical to EQV = baseret p/equivalent to MOD = modificeret/modified Kommentarer skal vre DS I hnde senest: Comments must be received by DS at the latest: 2006-07-31 2006-07-31 For
4、slag til Dansk titel: Kosmetik - Retningslinier for god fremstillingspraksis (GMP) Proposal for English title: Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO/FDIS 22716:2007) Vi modtager gerne dine kommentarer. Dette foregr ved at rekvirere en elektr
5、onisk kommen- tarskabelon hos projektlederen. Skabelonen udfyldes og returneres til projektlederen, inden hringsperiodens udlb. Dine kommentarer vil blive behandlet af det teknisk ansvarlige udvalg. DS appreciates your comments. A template for comments must be used and is obtained from the responsib
6、le project manager. Your com- ments are treated in the DS committee responsi- ble for the area. Standardiseringsudvalg: DS committee: Projektleder: Project manager: Maibritt Agger - email: magds.dk Bemrk at forslaget skal bearbejdes yderligere, og det har derfor ikke gyldighed som Dansk Standard Not
7、e that the draft will be edited fur- ther and has no validation as a Dan- ish Standard. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without licens
8、e from IHS -,-,- EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM FINAL DRAFT prEN ISO 22716 June 2007 ICS 71.100.70 English Version Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO/FDIS 22716:2007) Cosmtiques - Bonnes Pratiques de Fabrication (BPF) -
9、 Lignes directrices relatives aux Bonnes Pratiques de Fabrication (ISO/FDIS 22716:2007) This draft European Standard is submitted to CEN members for parallel formal vote. It has been drawn up by the Technical Committee CEN/SS H99. If this draft becomes a European Standard, CEN members are bound to c
10、omply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
11、language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, F
12、inland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Warning : This document is not a European Standard. It is distributed for review
13、 and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in
14、 any form and by any means reserved worldwide for CEN national Members. Ref. No. prEN ISO 22716:2007: E Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitte
15、d without license from IHS -,-,- prEN ISO 22716:2007 (E) 2 Foreword This document (prEN ISO 22716:2007) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with CMC. This document is currently submitted to the parallel Formal Vote. Endorsement notice The text of ISO 2271
16、6:2007 has been approved by CEN as prEN ISO 22716:2007 without any modifications. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from
17、 IHS -,-,- Please see the administrative notes on page iii RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORT- ING DOCUMENTATION. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUST
18、RIAL, TECHNO- LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STAN- DARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. Reference number ISO/FDIS 22716:2007(E) ISO 2007 FINAL DRAFT ISO/TC 2
19、17 Secretariat: ISIRI Voting begins on: 2007-06-14 Voting terminates on: 2007-08-14 INTERNATIONAL STANDARD ISO/FDIS 22716 Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufacturing Practices Cosmtiques Bonnes Pratiques de Fabrication (BPF) Lignes directrices relatives aux Bonnes P
20、ratiques de Fabrication Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO/FDIS 22716:2007(E) PDF disclaimer This PDF
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22、he responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF
23、-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. Copyright notice This ISO docu
24、ment is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the users country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photoco
25、pying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 1
26、1 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. ii ISO 2007 All rights reserved Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001
27、, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO/FDIS 22716:2007(E) ISO 2007 All rights reserved iii ISO/CEN PARALLEL PROCESSINGISO/CEN PARALLEL PROCESSING The CEN Secretary-General has advised the ISO Secretary-Gener
28、al that this final draft International Standard covers a subject of interest to European standardization. Consultation on the ISO/DIS had the same effect for CEN members as a CEN enquiry on a draft European Standard. In accordance with the ISO-lead mode of collaboration as defined in the Vienna Agre
29、ement, this final draft, established on the basis of comments received, is hereby submitted to a parallel two-month FDIS vote in ISO and formal vote in CEN. Positive votes shall not be accompanied by comments. Negative votes shall be accompanied by the relevant technical reasons. Copyright Dansk Sta
30、ndard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO/FDIS 22716:2007(E) iv ISO 2007 All rights reserved Contents Page Foreword.v Introducti
31、on .vi 1 Scope1 2 Terms and definitions.1 3 Personnel.4 4 Premises 6 5 Equipment8 6 Raw materials and packaging materials.10 7 Production .11 8 Finished products.14 9 Quality control laboratory15 10 Treatment of product that is out of specification17 11 Wastes17 12 Subcontracting18 13 Deviations19 1
32、4 Complaints and recalls.19 15 Change control19 16 Internal audit20 17 Documentation20 Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license
33、 from IHS -,-,- ISO/FDIS 22716:2007(E) ISO 2007 All rights reserved v Foreword ISO (the International 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 techni
34、cal committees. Each member body interested in a subject for which a technical committee has been 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 w
35、ith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 Int
36、ernational Standards adopted by the technical committees are circulated to the member bodies for 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 m
37、ay be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22716 was prepared by Technical Committee ISO/TC 217, Cosmetics. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan,
38、 IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO/FDIS 22716:2007(E) vi ISO 2007 All rights reserved Introduction These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These
39、 guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. The guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality. The guidelines h
40、ave 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 to each major section. Good Manufacturing Practices constitute the practical development of the qual
41、ity 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 activities that enable you to obtain a product that meets defined characteristics. Documentation is an integ
42、ral part of Good Manufacturing Practices. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/09/2007 23:37:18 MSTNo reproduction or networking permitted without license from IHS -,-,- FINAL DRAFT INTERNATIONAL STA
43、NDARD ISO/FDIS 22716:2007(E) ISO 2007 All rights reserved 1 Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufacturing Practices 1 Scope This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the
44、quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do 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
45、regulation. These guidelines are not applicable to research and development activities and distribution of finished products. 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 meas
46、ures for acceptance of test results 2.2 audit systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives 2.3 batch defined qua
47、ntity of raw material, packaging material or product issued from one process or series of processes so that it could be expected 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
48、 completed processing stages up to, but not including, final packaging 2.6 calibration set of operations that establish, 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 Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=IHS