欧洲当局关于验证缺陷的观点

一沙一叶

         European authorities' viewpoint on validation deficiencies
                 欧洲当局关于验证缺陷的观点

Amongst other things, this publication addresses deficiencies concerning validation/qualification. Deficiencies in those areas hold the 5th place of most frequently mentioned deficiencies. In the year before that, validation only held the 8th place, although qualification deficiencies weren't included at the time; they hadn't been mentioned, at any rate.
MHRA公布的这份资料中阐述了关于验证/确认的缺陷。这些领域的缺陷占据着最常提到的缺陷的前五名。在今年之前，验证只是在第8的位置，尽管这次没有涉及到确认的缺陷；它们以前从来未被提及过。
The deficiencies concerning the sections of Annex 15 of the European GMP guidelines are shown in table form, divided into critical, major and other deficiencies. The number of critical deficiencies is relatively low. In view of major deficiencies, the chapter cleaning validation comes in first place with over 20 citations, followed by deficiencies in organisation and planning, documentation (and validation master plan) and Quality System. Most "other deficiencies" can also be found in the chapters organisation and planning, documentation (and validation master plan) and Quality System.
关于欧盟GMP指南附录15中这部分内容的缺陷被列在表中，分成严重、重要和其它缺陷。严重缺陷数量相对低。关于重要缺陷，关于清洁验证的章节最多有20个，紧接着是组织和计划，文档（和验证主计划），质量系统。
The report also lists some exemplary findings: there was no change control process implemented, for example.  There was no or only an insufficient user requirement specification. The validation master plan was not specific enough (no consideration of utilities, process validation and cleaning validation). The cleaning validation hasn't been performed. Processing parameter ranges haven't been covered by the validation. There was no general statement that validation batches are releasable for commercial sale.
报告中也列出了一些典型的缺陷：例如，没执行变更控制流程。没有或者只有不充分的URS。验证主计划并不是足够有针对性的（没有考虑公共设施、工艺验证和清洁验证）。清洁验证没有被执行。工艺参数的范围没有被验证覆盖。没有整体的描述来说明验证批次可以用于商业使用。

麦田.守望

For more details please also see the complete MHRA GMP Inspection Deficiency Data Trend 2016.
http://www.gov.uk/government/upl ... Data_Trend_2016.pdf

scslk0045

学习一下

syhorchid

了解一下

北重楼

验证对于产品质量和过程控制还是蛮重要的

zsf19880416

清洁验证没有被执行，

xqliu

学习一下啦，谢谢提供分享。

一沙一叶

roadman 发表于 2017-5-19 13:25
For more details please also see the complete MHRA GMP Inspection Deficiency Data Trend 2016.
http: ...

Thanks

wanggui_929

看看，

danna

原来是这样，谢谢分享。学到东西了

werewolfman

学习学习。