PIC/S Committee adopted a new Guidance on Classification of GMP Deficiencies ...

胜利者

A global Approach to Classification of GMP Deficiencies?

Most of the inspectorates do classify their findings. In the European Union (EU) for example, the "Compilation of Community Procedures on Inspections and Exchange of Information" is a tool to standardise procedures for GMP-inspectorates and defines the nomenclature of "Significant Deficiencies". This system for categorising deficiencies is used in every EU Member State and the pharmaceutical companies are familiar with this system.

It defines the following categories:

• Critical deficiency
• Major deficiency
• Other deficiency
  

Now, The PIC/S Committee adopted a new Guidance on Classification of GMP Deficiencies (PI 040-1), developed by the PIC/S Working Group on Classification of Deficiencies, chaired by Australia / TGA (source: PIC/S press release). After implementation, the guidance will provide a tool to "support the risk based classification of GMP deficiencies from inspections and to ensure greater consistency amongst inspectorates". The idea is to help ensuring consistency across inspectorates of what constitutes a "critical" deficiency and what constitutes a "major" deficiency.

哪位大咖共享一下？

麦田.守望

着急看

• Risk classification guide for drug good manufacturing practices observations (GUI-0023) [2018-02-28] （加拿大是PIC/S的积极参与者）
  

胜利者

在PIC/S的网站上找不到PI 40，哪位有权限的大咖分享一下

胜利者

期待大咖分享

胜利者

期待大咖来打卡

麦田.守望

12月应该会发布。并不是一个很重要的文件

补充内容 (2019-1-4 11:40):
https://www.picscheme.org/layout/document.php?id=1609

胜利者

谢谢！期待大咖把pics的整出来

kc1711422001

Thanks for sharing

一杯敬过往

我也在找，官网上好像还没有

胜利者

期待大咖翻译成方块字

huazhang

Thanks for sharing

小金库

非常感谢分享

Bevann

期待分享。。。。。。