PIC/S GMP Guide(PE 009-13)最新修订

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Background : PIC/S GMP was last  revised on Oct 1,2015. The revision was PE 009-12.The EU and the PIC/S GMP Guide have been developed in parallel and whenever a change has been made to one, the other has been amended so that both Guides are practically identical.
背景：PIC/S GMP指南上次是在2015年10月1日修订。版本是PE 009-12。EU GMP和PIC/S GMP平行发展，无论哪一个发生变更，另一方的GMP也要跟着做相应的修订，这样两个指南实际上保持相同。

Purpose: For converging with EU GMP, PIC/S revised its GMP Guide PE 009-12   (Part I). Now the whole version is PE 009-13.
目的：为了和EU GMP一致，PIC/S对GMP指南PE 009-12 (Part I)进行修订。现在新的版本为PE 009-13。

Scope: the following chapters were revised:
范围：以下章节被修订：
      
Chapter 1 on “Quality Management” (which has become “Pharmaceutical  Quality Systems”).
第1章关于“质量管理” (这个已经改为“制药质量体系”)。

Chapter 2 on“Personnel”. A section on consultants has been added in it.
第2章关于“人员”。这部分增加了顾问内容。

Chapter 6 on “Quality Control”. All sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.
第6章关于“质量控制” 。对所有章节进行了审核和修订，增加了“测试方法技术转移”的新部分。

Chapter 7 on“Contract Manufacture and Analysis” (which has become “Out sources Activities”).The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”.
第7章关于“合同生产与分析” (这已经改为“外包活动”) 。第7章范围已扩展超出了“合同生产和分析”范围。

It was released on December 22, 2016 and entered into force on January 1, 2017.
发布日期为2016年12月22日，于2017年1月1日生效。

Summary: The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EUGMP Guide with some minor differences in terms of language. Chapters 1, 2 &7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated.
总结：对PIC/S GMP部分章节1，2，6和7的修改是根据欧盟GMP指南的相应章节进行的，只是在语言措辞方面有一些小的差异。第1，2和7章已与ICH Q10保持一致并且融入了“制药质量体系”的原则。

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