ECA公布《工艺验证优良规范指南》修订版本

20151104 ECA新闻： ECA公布《工艺验证优良规范指南》修订版本  

   

GMP News
04/11/2015

ECA publishes revised version of GoodPractice Guide on Process Validation

ECA公布《工艺验证优良规范指南》修订版本

Since the publication ofFDA?s Process Validation Guidance in 2011, validation has become a lifecycle approach with focus on process knowledge and process understanding basedon scientific sound principles. In addition, with the revision of Annex 15of the EU GMP Guide, the EU has also been moving to modern process aspects(e.g. life cycle approach).

自FDA工艺验证指南在2011年公布后，验证已成为一个生命周期方法，它关注基于科学合理原则的工艺知识和工艺理解。另外，随着EU GMP附录15的修订，EU也在向现代化工艺方面发展（例如，生命周期方法）。

The question is how to implement thesenew requirements - in the USA and in Europe?

问题是如何实施这些要求---在USA和在欧洲？

To answer this question, an ECA WorkingGroup has revised the Version 1 of ECA?s Good Practice Guide onValidation. With the revision the group wants to provide support to bothregulators and industry. On one hand, the guide contains the main elements ofthe new approach ("what to do"). On the other hand, it also serves asa supporting guide for the implementation ("how to do").

为了回答这些问题，ECA工作组已修订了ECA的《验证优良规范指南》第1版。通过修订，工作组希望能给法规工作人员和制药行业提供支持。一方面，指南包括了新方法的要素（做什么），另一方面，它也作为一个支持性指南用于实施（如何做）。

The revised version comprises174 pages divided in 5 chapters and 5 annexes (with detailed analyses ofthe regulatory guidances).

修订版包括174页，分为5章和5个附录（有对法规指南的详细分析）。

The topics covered are e.g.:

所包括的主题有，如：

·        risk based qualification and validation

·        基于风险的确认和验证

·        legacy products

·        遗留产品

·        Statistics

·        统计

·        case study about process validation

·        工艺验证各案研究

·        case study about continued/ongoing process verificationin biopharmaceutical manufacturing

·        生物药品生产的持续工艺确认各案研究

The ECA Good Practice Guide onValidation will be officially launched at ECA?s Annex 15 Conference on25/26 November 2015 in Berlin. All participants will receivea free copy of the document.

CEA《验证优良规范指南》将在2015年11月25/26日柏林的ECA附录15研讨会上正式发布。所有参与者将收到一份免费版本。

来源：http://zhuyujiao1972.blog.163.co ... 472720151054751200/

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