EU-GMP附录15：确认与验证.docVIP

EU GMP附录15：确认与验证 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, 30 March 2015 EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation EU GMP附录15：确认和验证 Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 公布详细指南的法律依据：指令2001/83/EC第47款关于人药共同体代码，和2001/82/EC第51款关于兽药共同体代码的要求。本文件为指令2003/94/EC中制订的人药GMP以及指令 91/412/EEC兽药GMP原则和指南提供诠释。 Status of the document: Revision 文件状态：修订 Reasons for changes: Since Annex 15 was published in 2001 the manufacturing and regulatory environment has changed significantly and an update is required to this Annex to reflect this changed environment. This revision to Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. 变更理由：自从附录15在2001年公布以来，生产和法规环境已发生了重大变化，有必要对此附录进行更新以反映环境的变化。本次对附录15的修订考虑了欧洲药事法卷4第一部分其它部分的变化，与第二部分、附录11、ICH Q8 Q9 Q10以及Q11、QWP的工艺验证指南的关系，以及生产技术的变化。 Deadline for coming into operation: 1 October 2015 最后实施时间：2015年10月1日 Principle 原则 This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for activ