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 In addition, with EMA´s new Process Validation Draft Guidance the EU has been also moving to modern process aspects (e.g. life cycle process).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。