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

Principle 总则

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

components which together fulfill certain functionalities.

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 operation, there should be n