EU-GMP指南-第1部分第2章-人员.pdfVIP

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE — GENERAL Public Health and Risk Assessment Medicinal Product – quality, safety and efficacy Brussels, 16 August 2013 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 2 ： Personnel 人药与兽药 GMP 指南 第 2 章:人员 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. 指南细则出版的立法基础 :2001/83/EC 法令第 47 款对人用药品的相关要求， 2001/82/EC 法令第 51 款兽用药相关的欧共体法规。 本文件主要是 2003/94/EC 法 令对人用药和 91/412/EEC 对兽用药品的 GMP 原则和指南的解释。 Status of the document: Revision 文件状态：修订 Reasons for changes: Changes have been made in order to integrate the principles of “Pharmaceutical Quality System as described in the ICH Q10 tripartite guideline. A section has been added on consultants 变更理由：变更是为了整合 ICH Q10 三方协调指南中所描述的 “药品质量体系 ” 的原则。增加了顾问部分。 Deadline for coming into operation ： 16 February 2014 实施最后期限： 2014 年 2 月 16 日 Principle 原则 The correct manufacture of medicinal products r