关于“年度回顾”是否能够代替“周期性再验证”的问题

beiwei5du

Two critical objectives that are specified in the EU PQRand Q7A PQR but not included in the FDA PAR are the verification of theconsistency of the existing manufacturing process and the determination of theneed for the revalidation of the manufacturing process.

Theprocedures for performing a typical PAR/PQR involve the review, analysis, andtrending of historical data (i.e., data generated in the past 12 months), which fit the definitionof retrospective process validation as defined in FDA's validation guidelineand the EU GMP Guide Annex 15 on qualification and validation (5, 6). A PAR/PQR is, therefore,actually an annual retrospective revalidation of the manufacturing process.When performed properly with the incorporation of the required elements of aretrospective process validation, and in the absence of significant processchanges, a PAR/PQR may negate or substitute the need for the periodicprospective revalidation (i.e., intensive sampling and testing) of themanufacturing process. This is supported by the following statementin Section 12.6 of Q7A: "Where no significant changes have been made tothe system or process, and a quality review confirms that the system or processis consistently producing material meeting its specifications, there isnormally no need for revalidation." A similar statement appears in item 44of the EU GMP Guide Annex 15. To take advantage of the PAR/PQR as theannual retrospective revalidation of the manufacturing process, the company'smaster validation plan for process validation should reference the PAR/PQRprogram as the determining factor for the need of a prospective revalidation ofthe manufacturing process, in the absence of significant changes.

如上文所说，在没有significant changes的情况下，PQR完全可以代替周期性的回顾性再验证（注意retrospecvtive validation和retrospective revalidation是完全不同的两个概念）。

选自《Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations》

静水蓝心

受教了！

叶非

无论是EU，还是FDA，对于工艺验证，都没有回顾性再验证的概念了！那么，PQR是针对产品的，能够代替的也就是工艺的验证，但是工艺验证都没有回顾性验证的说法了，这个代替还有意义么？

beiwei5du

uiofer 发表于 2016-10-29 22:14
无论是EU，还是FDA，对于工艺验证，都没有回顾性再验证的概念了！那么，PQR是针对产品的，能够代替的也就是 ...

首先需要区分回顾性验证和回顾性再验证（即周期性再验证）的概念的区别！回顾性验证在工艺验证层面确实不提倡了，这个是在特定阶段特定时候针对于以前的legacy product的。但是回顾性再验证（周期性再验证），这个词是允许的，我们现在所说的再验证有两种：周期性再验证和变更后再验证，这个不冲突！

beiwei5du

uiofer 发表于 2016-10-29 22:14
无论是EU，还是FDA，对于工艺验证，都没有回顾性再验证的概念了！那么，PQR是针对产品的，能够代替的也就是 ...

可能是用词的问题，很少有听到本文提到的retrospective revalidation的，大家都一般叫做periodic revalidation的

victorming

periodic revalidation和retrospective revalidation也不是一个意思吧

叶非

beiwei5du 发表于 2016-10-29 22:22
首先需要区分回顾性验证和回顾性再验证（即周期性再验证）的概念的区别！回顾性验证在工艺验证层面确实不 ...

变更后的再验证存在，但是周期性的再验证就是持续工艺验证阶段，而非是回顾性的验证。当然，因为这个法规也是2015年10月才生效的，还有些人的概念并没有更新过来，是有可能的。在回顾性验证的概念还存在的时候，两者确实有很多共同点，可以互相代替。

叶非

纠正下，不是互相代替，而是PQR可以代替工艺的回顾性验证。

scslk0045

同意楼主的观点

xqliu

学习一下啦，谢谢提供分享。

wyyalih

学习了，谢谢讨论

小金库

谢谢分享!