再验证和持续性验证（日常监管/周期性回顾）

beiwei5du

Historically, it was considered acceptable to perform periodic revalidation on cleaning processes in lieu of routine monitoring and periodic review. However, the approach of revalidation yields a much less robust picture of the state of control of the cleaning process and may be more resource -intensive. Revalidation as a concept is no longer used by some regulatory agencies because of a preference for alifecycle validation approach. Under a lifecycle validation approach, a significant change in a cleaning process involves not the revalidation of the previous process, but rather validation of a new process.Such validation of a new process, however, may rely on data from the old process based on it being sufficiently similar.

持续性验证（日常监察/周期性回顾）将取代再验证

孙艳红

就如GMP检查常态化，持续保持验证状态，比日常不问，定期再验证效果的多

yuansoul

中英文对不上

xylei

英文看不懂，。

wgt-王

新版GMP规定有“工艺验证、工艺持续性确认、再验证”，没有说增加了工艺持续性确认，就把再验证取消了！！！只是在时间点上，在验证与再验证之间又增加了一个“持续性确认”

补充内容 (2015-10-17 16:03):
最初3批验证与年度质量回顾之间，增加了持续工艺确认！！

beiwei5du

wgt-王 发表于 2015-10-16 07:57
新版GMP规定有“工艺验证、工艺持续性确认、再验证”，没有说增加了工艺持续性确认，就把再验证取消了！！ ...

这个持续性验证代替再验证，应该是个趋势？

尼采

楼主英语水平很高吗

大呆子

持续验证如何具体实施？

gao7869

学习了，谢谢。

xqliu

学习一下啦，谢谢提供分享。

十二月的雪

这个好像与是否取代再验证没啥关系啊！！！我英语不好别忽悠我！

beiwei5du

尼采 发表于 2015-10-16 08:52
楼主英语水平很高吗

不好！正在学习！

beiwei5du

十二月的雪 发表于 2015-10-16 11:02
这个好像与是否取代再验证没啥关系啊！！！我英语不好别忽悠我！

我英语不好忽悠你了！

尼采

beiwei5du 发表于 2015-10-16 11:11
不好！正在学习！

我都看不懂，还是你厉害

wgt-王

beiwei5du 发表于 2015-10-16 08:14
这个持续性验证代替再验证，应该是个趋势？

应该是两个概念

是是而非

beiwei5du 发表于 2015-10-16 08:14
这个持续性验证代替再验证，应该是个趋势？

中国的法规是还有再验证的。
大概是偏差、变更引发，持续性确认中有不良趋势引发等

beiwei5du

Process Validation
The options with regard to process validation have been extended. The previous "traditional" approach is still mentioned as a possibility, though - also with the determination of 3 validation batches. For a 3 batch validation further data from following batches may be necessary according to an "ongoing process verification". The possibility of a "continuous process verification" as described in ICH Q8, and a hybrid approach as a mix of the before mentioned two approaches is new. This is a clear difference to the US FDA Process Validation Guidance where only one approach is mentioned. According to the final EU GMP Annex 15 a "bracketing" approach can be used with respect to the number of runs, strength, batch size, packaging sizes and types. This is already known from the US.

As part of the "ongoing process verification" the product quality should be monitored during the product life cycle to show that the "state of control" is fulfilled and that trends are assessed. This is also known as "Continued Process Verification" from the US. The "ongoing process verification" should be based and reported according to a protocol or equivalent documents, latter is new compared to the draft. Completely omitted has been the subject of a (regular) revalidation.
from<EU GMP Annex 15>

beiwei5du

More than half of the participants assessed removing the routine validation (question 8) as understandable as it is replaced by the ongoing process verification. But 36.6% would still like to regularly revalidate based on a risk assessment, and 6.4% even without a risk analysis. Just as many participants will only do this in a sterile area (e.g. at Medial Fills).
The hybrid approach is also only clear to just under 50% of participants. With the request for ongoing process verification, the majority of the industry (60.4%) believes this will result in additional work, while 50% also believe discontinuing the routine revalidation will result in additional work.

from<Validation - Revision of Annex 15: How does the Industry see the Changes? - Results of an ECA Survey>

Other important changes compared to the current version are:

• There are new terms that are not explained in the glossary, such as "ongoing validation strategy"
• Retrospective validation and the notion of revalidation are gone completely - except  for one exemption
• from<Revision of the EU GMP Annex 15 for Qualification and Validation published>
  

form<Revision of the EU GMP Annex 15 for Qualification and Validation published>

zyjkf

long long ago.More and More

bsblulei

谢谢分享 学习了 ！