ISPE GAMP COP对EU GMP附录Ⅱ计算机化系统注释.pdf

人间四月天作品，特约审核专家：zhulikou431 GAMP CoP Annex 11 Interpretation ISPE GAMP COP对EU GMP附录11计算机化系统注释 说明：任何关于此文件的宝贵建议和意见都可以和翻译者联系沟 通。请致函zhulikou431@126.com,欢迎赐教。 解读本首发于丁香园论坛，欢迎转载、下载、学习和讨论。转载 请注明来自dxy论坛。 人间四月天作品，特约审核专家：zhulikou431 GAMP CoP Annex 11 Interpretation GAMP COP对EU GMP附录11计算机化系统注释 Authors: Winnie Cappucci / Chris Clark / Tim Goossens / Sion Wyn Date: 7th June 2011 Introduction介绍 This interpretation of the revised Annex 11 requirements has been produced by a core GAMP CoP Task Team, and reviewed by the GAMP CoP Council and members of GAMP Regional Steering Committees. EU GMP附录11（修订版）的注释工作已经由GAM COP核心工作小组完成，并经过 GAMP COP委员会和GAMP区域管理委员会成员审核。 The GAMP CoP believes that there is nothing in the revised Annex 11 - if interpreted in a pragmatic and reasonable way - that should cause major concern or problems to any regulated company that was complying with the previous Annex 11, and generally following good practice as defined in GAMP 5 and associated key Good Practice Guides. GAMP COP相信，如果采用务实和合理的方式来解释，EU GMP附录11对于任何规范 的公司没有什么可以引起主要关注或者问题的内容，以前这些公司符合附录11 要求，并大体遵循GAMP5确定的良好规范和相关的关键的良好规范指南。 The revised Annex 11 adopts a risk based approach, and is aligned with current industry good practice. EU GMP附录11采用了基于风险的方法，也和目前工业良好规范相结合。 There is a risk of regulated companies and their suppliers over-analysing detailed wording (either new or changed) in extreme detail, looking for nuances and distinctions not intended by the authors of the regulation. 规范的公司和他们的供应商如果以极端方式过分分析细节词句（或者是新的内 容，或者是修改的内容），寻找本不是法规作者意图体现的细节之处和区别，那 么是有害的。 The GAMP CoP advocates a sense of perspective and balance, and avoiding any unnecessary over-reaction to a sensible and reasonable piece of regulation. GAMP COP建议采取一种展望和平衡的感觉，并避免任何不必要的对法规敏感和合 理部分的过分反应。 Overview概述 The European Commission (EC) has announced a new revision of EU GMP Annex 11 Computerised Systems, and consequential amend