EN ISO 15378-2011 8125 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001 2008 with reference to Good Manufacturing Practi.pdf
《EN ISO 15378-2011 8125 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001 2008 with reference to Good Manufacturing Practi.pdf》由会员分享,可在线阅读,更多相关《EN ISO 15378-2011 8125 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001 2008 with reference to Good Manufacturing Practi.pdf(82页珍藏版)》请在麦多课文档分享上搜索。
1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15378:2011Primary packaging materialsfor medicinal products -Particular requirements for the applicationof ISO 9001:2008, with reference toGood Manufacturing Practice (
2、GMP) (ISO15378:2011)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO
3、15378:2011. It supersedes BS EN ISO 15378:2007 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all
4、 the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68838 6ICS 03.120.10; 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Poli
5、cy and Strategy Committee on 30 November 2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPEN
6、NE EUROPISCHE NORM EN ISO 15378 November 2011 ICS 03.120.10; 11.040.01 Supersedes EN ISO 15378:2007English Version Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011) A
7、rticles de conditionnement primaire pour mdicaments - Exigences particulires pour lapplication de lISO 9001:2008 prenant en considration les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2011) Primrpackmittel fr Arzneimittel - Besondere Anforderungen fr die Anwendung von ISO 9001:2008 entsprechen
8、d der Guten Herstellungspraxis (GMP) (ISO 15378:2011) This European Standard was approved by CEN on 3 November 2011. CEN members are 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 an
9、y alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the 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 langua
10、ge made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,
11、 Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION
12、 EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15378:2011: ECopyright European Committee for Standardization Provided by IHS under licen
13、se with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011EN ISO 15378:2011 (E) 3 Foreword This document (EN ISO 15378:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment
14、 for medical and pharmaceutical use“. 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 2012, and conflicting national standards shall be withdrawn at the latest by May 2012. Attention is drawn
15、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. This document supersedes EN ISO 15378:2007. According to the CEN/CENELEC Internal Regulations, the nation
16、al standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, N
17、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15378:2011 has been approved by CEN as a EN ISO 15378:2011 without any modification. Copyright European Committee for Standardization Provided by IHS under lice
18、nse with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword . v Introduction vi 0.1 General vi 0.2 Process approach viii 0.3 Relationship with ISO 9004 x 0.4 Compatibility
19、with other management systems . x 1 Scope 1 1.1 General . 1 1.2 Application . 1 2 Normative references 2 3 Terms and definitions . 2 4 Quality management system 12 4.1 General requirements . 12 4.2 Documentation requirements 13 5 Management responsibility 16 5.1 Management commitment 16 5.2 Customer
20、 focus . 16 5.3 Quality policy . 17 5.4 Planning . 17 5.5 Responsibility, authority and communication . 18 5.6 Management review 19 6 Resource management . 20 6.1 Provision of resources 20 6.2 Human resources 20 6.3 Infrastructure . 22 6.4 Work environment . 22 6.5 Maintenance activities 23 7 Produc
21、t realization 24 7.1 Planning of product realization 24 7.2 Customer-related processes 25 7.3 Design and development 26 7.4 Purchasing . 29 7.5 Production and service provision . 31 7.6 Control of monitoring and measuring equipment . 36 8 Measurement, analysis and improvement 37 8.1 General . 37 8.2
22、 Monitoring and measurement 37 8.3 Control of nonconforming product . 40 8.4 Analysis of data . 41 8.5 Improvement 41 Annex A (normative) GMP requirements for printed primary packaging materials 43 Annex B (informative) Guidance on verification and validation requirements for primary packaging mater
23、ials 47 Annex C (informative) Guidance on risk management for primary packaging materials . 56 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(
24、E) iv ISO 2011 All rights reservedBibliography 63 Index .65 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) ISO 2011 All rights reserved vFo
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
10000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ENISO1537820118125PRIMARYPACKAGINGMATERIALSFORMEDICINALPRODUCTSPARTICULARREQUIREMENTSFORTHEAPPLICATIONOFISO90012008WITHREFERENCETOGOODMANUFACTURINGPRACTIPDF
链接地址:http://www.mydoc123.com/p-725591.html