产品年度回顾包括了previous review了吗？？

beiwei5du · 发表于 2016-10-29 23:06:57

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The EU PQR requires that reviews performed in previousperiods be taken into account as part of the current review. This has been anexpectation of FDA, as indicated by the many FDA 483 observations, despite nomentioning of this in FDA GMPs or other guidance documents. Although this requirementis also not mentioned in the Q7A, the PQR for active pharmaceutical ingredientsshould include the trending of PQR results from previous periods because thisis required by the EU and expected by FDA.

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静水蓝心 · 发表于 2016-10-30 07:25:13

好文章！

zysx01234 · 发表于 2016-10-30 08:38:35

路过，啥也不看

jixia · 发表于 2016-10-30 10:29:53

表示收到，已查阅

xqliu · 发表于 2016-10-30 13:29:29

学习一下啦，谢谢提供分享。

beiwei5du · 发表于 2016-10-30 18:23:53

本帖最后由 beiwei5du 于 2016-10-30 18:25 编辑

4.0 PROCEDURE:
4.1 Product Quality Review should typically be carried out for each product manufactured in the previous year. In the case of campaign manufacturing, the review period can be extended beyond a year. Such extensions shall be for a limited number of months and as described in a procedure. Along with PQR, implementation of preceding years’ recommendations shall be reviewed

选自新加坡HSA 产品质量回顾guidance notes

hongwei2000 · 发表于 2016-10-31 08:38:58

我之前做的产品
批次少的都会带上去年
但批次多的一般不带
不过有线下滚动的数据

Maria2015 · 发表于 2017-6-3 13:07:37

我前两年做的PQR就把该部分内容加进去了

frankliuyun · 发表于 2017-6-6 09:52:39

学习一下啦，谢谢提供分享。

w616 · 发表于 2017-6-6 10:06:40

当年的回顾应该对上年的回顾中提出的建议和改进措施的实施情况进行回顾！

乔乔1 · 发表于 2018-11-27 15:08:16

学习了，谢谢分享

小金库 · 发表于 2023-2-22 22:11:06

非常感谢分享

[GMP相关] 产品年度回顾包括了previous review了吗？？

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