欧盟GMP附录11-计算机系统(中英文对照)

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 no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

用计算机系统代替手动操作应不对产品质量、过程控制和质量保证以及过程的整体风险产生影响。

General常规

1. Risk Management 风险管理

Risk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system.

风险管理应贯穿整个计算机系统生命周期，以保证病人安全、数据完整性和产品质量。作为风险管理系统的一部分，由计算机系统风险评估决定验证范围和数据完整性控制。

2. Personnel 人员

There should be close cooperation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.

所有有关人员（如工艺管理员、系统管理员、质检员和IT人员）应紧密合作。这些人员应具有相应的资格证书、使用权限和定义好的相关工作职责。

3. Suppliers and Service Providers 供应商和服务供应商

3.1 When third parties (e.g. suppliers, service providers) are used e.g. to provide, install, configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related service or for data processing, formal agreements must exist between the manufacturer and any third parties, and these agreements should include clear statements of the responsibilities of the third party. IT-departments should be considered analogous.

3.1当第三方(如供应商、服务供应商)为计算机系统、相关服务或数据处理提供如供货、安装、配置、整合、验证、维护(如通过远程访问)、修改或保持时，厂商