欧盟gmp附录11-计算机系统(中英文对照).docx

EUROPEAN COMMISSION 欧盟委员会 HEALTH AND CONSUMERS DIRECTORATE-GENERAL 卫生与消费者协会 Public Health and Risk Assessment 公共卫生与风险评估 Pharmaceuticals 药品 Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products in the European Union 欧盟药品生产规范 Volume 4 卷4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use 人用与兽用药品良好生产管理规范 Annex 11: Computerised Systems 附件 11：计算机系统 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. 依法发布的具体指导方针： 2001/83/EC 第47条人用药品规范和 2001/82/EC 第51条 兽用药品规范。此文件为 2003/94/EC 人用药品和 91/412/EEC 兽用药品 GMP 法规、 指导方针的解释提供了指导。 Status of the document: revision 1 文件版本：修订本 1 Reasons for changes: the Annex has been revised in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide. 修订原因： 为增强计算机系统的功能和复杂性而修订此附件。 相应修正案也已被 提议作为 GMP 指南的第 4章。 Deadline for coming into operation: 30 June 2011 生效时间： 2011年6月 30日 Prin ciple 总贝 U This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware comp onents which together fulfill certa in fun cti on alities. 此附件适用于符合GMP生产要求的所有形式的计算机系统。计算机系统是实现 某项特定功能的软件和硬件的组合。 The application should be validated; IT infrastructure should be qualified. 应用程序应验证，IT基础设施应有权限设置。 Where a computerised system replaces a manual operati on, there should be no resulta nt decrease in product quality, process con trol or quality assura nee. There sh