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1、 .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 Practi
2、ce 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/E
3、C 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 Directi
4、ve 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 i
5、ncreased 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 use
6、d 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
7、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
8、 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 doc
9、umented 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 a
10、ppropriate 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 prov
11、ide, 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
12、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，厂商和任何第三方之间必须有正式协议，且在协议中应当明确第三方责任。IT部门类似。 3.2 The competence and reliability of a supplier are key factors when selecting a product or service pr
13、ovider. The need for an audit should be based on a risk assessment. 3.2供应商的实力和可靠性是选择供应商产品或服务的关键因素，所以需要一个以风险评估为基础的审计。 3.3 Documentation supplied with commercial off-the-shelf products should be reviewed by regulated users to check that user requirements are fulfilled. 3.3商业性标准文件应通过用户审核并符合用户需求。 3.4 Qu
14、ality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request. 3.4软件和应用系统开发商或供应商的质量体系和审计信息应便于核查人员查询。 Project Phase 项目阶段 4. Validation 验证 4.1 The validation documentation and reports should cover the releva
15、nt steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.1 验证文件和报告应包含系统生命周期的相关阶段。厂商应能够证明其标准、协议、验收标准、规程和记录都是基于其内部风险评估的。 4.2 Validation documentation should include change control recor
16、ds (if applicable) and reports on any deviations observed during the validation process. 4.2 验证文件应包含验证过程中的变更控制记录（如适用）和偏差报告。 4.3 An up to date listing of all relevant systems and their GMP functionality (inventory) should be available. 4.3 相关系统和其GMP 功能（详细目录）的最新清单应有效。 For critical systems an up to date system description detailing the physi
