欧盟GMP附录15：确认与验证(修订版英文+中文)

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels,30 March 2015 EudraLex 欧盟药品管理法 Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use 第四卷 欧盟人用和兽用药品GMP指南 Annex 15: Qualification and Validation 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. 发布该细化指南的法律依据:人用药物欧共体法案指令2001/83/EC 第47 章和兽用药物欧共体法案指令2001/82/EC 第51 章。本文件为人药GMP指令2003/94/EC 以及兽药GMP指令91/412/EEC 的原则和指南提供诠释。 第 2 页 共32 页 Statu s of the docu ment: Revision 文件状态：修订版 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. 变更原因：从2001 年附录15 发布以后，制药生产和法规环境都有了显著变化，需要相应的更新来反映变化的环境。本文对附录15 所做的修订考虑了欧盟法规第四卷第一部...