欧盟GMP附录15：确认与验证(修订版英文+中文).pdfVIP

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。 1 / 35 欧盟 GMP 附录 15：确认与验证 (修订版英文 + 中文 ) 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