ECA发布了工艺验证的实施指南

GmpForEver

Since the FDA has revised its "old" Validation Guidance in 2011, validation has become a life cycle process with focus on process knowledge and process understanding based on scientific sound principles. The qualification steps DQ, IQ, OQ, PQ and the "magic" 3 batches are not mentioned any more in the new guidance. In addition, with EMA´s new Process Validation Draft Guidance the EU has been also moving to modern process aspects (e.g. life cycle process). Now, the question is how to implement these new requirements? To answer this question, an ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").
The guide contains 163 pages divided in 5 chapters and 4 annexes. The topics covered are e.g.:

• risk based qualification and validation
• legacy products
• statistics
• case study about process validation in biopharmaceutical manufacturing
• case study about continuous process verification
  

       因FDA在2011年修订了验证指南，验证变成了基于科学理论的关注工艺知识和理解的生命周期方法，在新的指南里不再提及DQ、IQ、OQ、PQ和3个验证批。另外，随着EMA的新工艺验证指南草稿出台，EU也转向新式的方法（比如生命周期方法）
现在，问题是如何执行这些要求？
      为了回答这个问题，ECA工作组建立了验证的实施指南（第一版）。这个文件为政府和企业提供了支持帮助。一方面，这个指南包括了新方法的主要内容（做什么），另一方面，也是执行的依据指南（如何做）。
      这个指南有163页，5个章节和4个附录，包括：
     1、基于确认和验证的风险
     2、原有的指南
     3、统计学
     4、生物制药工艺验证案例
     5、连续的工艺确认案例

有这个指南的可以共享讨论一下。

kslam

李蜃 发表于 2012-12-11 15:08
不知指南在何处？

ECA (European Compliance Agency) 是GMP培训公司. 指导由他们编写的. 149欧元.

http://www.gmp-compliance.org/eca_news_liste_2012.html

罗伊鲱

Good Practice Guide on Validation

The ECA was one of the first organisations which published a Good  Practice Guide regarding the new FDA Process Validation Guidance. With the  revision of the Annex 15 also this Good Practice Guide has to be updated. As  1st revision the guide contains on one hand the main elements of the new  validation approaches ("what to do"). On the other hand, it also  serves as a supporting guide for the implementation ("how to do").      The guide contains 177 pages divided in 5 chapters and 5 annexes. The topics  covered are e.g.:    risk based qualification and validation legacy products statistics case study about process validation in biopharmaceutical manufacturing case study about continuous process verification    >>> Download ECA's Validation Good Practice Guide(Size:  5,39 MB)

附件是2015年12月版。2012年9月草案见：http://www.dxy.cn/bbs/thread/40500128

罗伊鲱

https://www.validation-group.org/pvg.cgi

郦无悔

期待期待！
不知道国内跟进的速度会有多快~~

心灵黑客

有新的了，麻烦贴出来分享一下。不胜感激。

李蜃

不知指南在何处？

syhorchid

期待并关注

sara_feng

好贵啊！有没有买的分享一下啊

jeanee

有没有电子版的分享一下   

康红

谢谢分享，学习学习

ycyber

roadman 发表于 2019-2-23 13:11
附件是2015年12月版。2012年9月草案见：http://www.dxy.cn/bbs/thread/40500128

粗看2012 和2015差别不是很大啊，继续学习中

罗伊鲱

Good Practice Guide Integrated Qualification and Validation

Qualification and Validation (Q&V) activities can be very time consuming, expensive and causing delay of new products to market, facility expansions etc. The purpose of this guide is thus to streamline Q&V by enabling a better cooperation and mutual understanding between customers and suppliers on projects related to pharmaceutical manufacturing systems, including equipment, facilities and utilities. Here you can download the Good Practice Guide "Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership" as well as a Word template for your comments. >> ECA Good Practice Guide - Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership (Size: 4,6 MB) >> Comment Form ECA Good Practice Guide Integrated Qualification and Validation

Good Practice Guide on Validation

The ECA was one of the first organisations which published a Good Practice Guide regarding the new FDA Process Validation Guidance. With the revision of the Annex 15 also this Good Practice Guide has to be updated. As 1st revision the guide contains on one hand the main elements of the new validation approaches ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do"). The guide contains 177 pages divided in 5 chapters and 5 annexes. The topics covered are e.g.: risk based qualification and validation legacy products statistics case study about process validation in biopharmaceutical manufacturing case study about continuous process verification >> ECA Validation Good Practice Guide Version 2.0(Size: 5,39 MB)

注：即2015年12月版

scslk0045

厕所所长 发表于 2019-2-23 13:11
附件是2015年12月版。2012年9月草案见：http://www.dxy.cn/bbs/thread/40500128

谢谢分享

李可维

厕所所长 发表于 2021-5-5 16:50
注：即2015年12月版

谢谢分享

小金库

非常感谢分享。