欧洲药监在验证缺陷方面的观点

17.05.2017

European authorities' viewpoint on validation deficiencies欧洲药监在验证缺陷方面的观点

End of April an article reported about the New Analysis of GMP Inspections by MHRA for the year 2016.

4月底，曾经有一篇文章报道过MHRA的2016年GMP检查新分析。

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.

除了其它内容外，该报告讲了关于验证/确认的缺陷。这些领域的缺陷在最常见缺陷中排名第五。前年，验证还只在第8位，当然确认缺陷那时并没有包括在其中，当时并没有提到。

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EU GMP指南附录15部分的缺陷以表格形式显示出来，分为关键、主要和其它缺陷。关键缺陷的数量相对较低。从主要缺陷来看，该章节清洁验证在20多个引用中居首位，其后是组织和计划、文件记录（和验证主计划）和质量体系缺陷。在组织和计划、文件记录（和验证主计划）和质量体系章节也可以找到大多数“其它缺陷”。

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.

报告还列出了一些缺陷解释：例如没有实施变更控制流程。没有或只有不充分的用户需求手册。验证主计划不够详细（没有考虑公用设施、工艺验证和清洁验证）。没有实施清洁验证。验证没有覆盖工艺参数的范围。没有总则性声明说验证批次商业规模可以放行。

For more details please also see the complete MHRA GMP Inspection Deficiency Data Trend 2016.

更多细节参见完整报告。