欧盟GMP附录11-计算机系统(中英文对照).pdf
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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
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
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针：2001/83/EC第47条人用药品规和2001/82/EC第51条兽
用药品规。此文件为2003/94/EC人用药品和91/412/EEC兽用药品GMP法规、指
导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
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