欧盟GMP附录15：确认与验证(修订版英文 中文).docx

MISSION 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 munity code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on munity 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/E C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 GM P 指令 91/412/EEC 的原则和指南提供诠释。 Status of the document : 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分质量管理和第二部分活性物质作起始物料以及附录 11 计算机化系统的验证、 ICH Q8 药物研发、 ICH Q9 质量风向管理、 ICH Q11 药物研发和生产、质量工作组的工艺验证指南和生产技术的变化。 Deadline ing into operation: 1 October 2015 最终实施日期: 2015 年 10 月1日目录原则................................................................................................................................ 2 概述.........................................................................................