EUROPEAN COMMISSION
欧盟委员会
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
卫生与消费者协会
Public Health and Risk Asssment
公共卫生与风险评估
贾里Pharmaceuticals
药品
Brusls,
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
小白兔Good Manufacturing Practice
Medicinal Products for Human and Veterinary U
人用与兽用药品良好生产管理规范
Annex 11: Computerid 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 u and Article 51 of Dir
ective 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 u and Directive 91/412/EEC for veterinary u.
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 revid in respon to the incread u of computerid systems and the incread complexity of the systems. Conquential amendments are also propod for Chapter 4 of the GMP Guide.
守侯
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日初一历史手抄报
Principle 总则
This annex applies to all forms of computerid systems ud as part of a GMP regulated activities. A computerid system is a t 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 computerid system replaces a manual operation, there should be no resultant decrea in product quality, process control or quality assurance. There should be no increa 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 computerid 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 bad on a justified and documented risk asssment of the computerid system.
风险管理应贯穿影子英语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。籁怎么读
2. Personnel 人员
There should be clo 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宋辽澶渊之盟
3.1 When third parties (e.g. suppliers, rvice providers) are to provide, install, configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerid system or related rvice or for data processing, formal agreements must exist between the manufacturer and any third parties, and the agreements should inclu
de 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)一五计划的时间为计算机系统、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 lecting a product or rvice provider. The need for an audit should be bad on a risk asssment.
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 urs to check that ur 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 Quality 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 Pha 项目阶段
4. Validation 验证
4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records bad on their risk asssment.
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 records (if applicable) and reports on any deviations obrved during the validation process.
