罗马尼亚药品生产商不符合报告引人注目

预知子

摘自Julia法规翻译 07.03.2018

ImpressiveNon-Compliance Report for Romanian Drug Manufacturer罗马尼亚药品生产商不符合报告引人注目

The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on aninspection in summer 2017 is available there, as well.

EMA在其GMDP数据库发布GMP检查不符合报告。2017年夏天有一个对罗马尼亚药品生产商现场的检查所发现的缺陷引人注目。

Overall, 12 deficiencies were rated "major". The list is quite long:

总共有12个主要缺陷，清单可算是够长：

• Inadequate CAPA system CAPA系统不充分
• No records for use of primary reference standards      无基准对照品使用记录
• No raw data of integrity and identity testing (of starting materials and finished products) available 无（起始物料和制剂）完整性和鉴别试验原始数据
• No checks of the log-books in the laboratory 对化验室日志无检查
• No records of the media preparation in the microbiology laboratory 微生物化验室的培养基制备无记录
• No checks of the data entered into the Certificate of Analysis     录入COA的数据无检查
• Errors and deficiencies     in the sampling documentation取样文件记录中有错误和缺陷
• Alterations of data in the log-book and     obliteration of former entries; failure to mention the person who made the changes 修改日志中的数据，涂去原录入；未提及修改人
• Poor conduct of qualification and validation     确认和验证执行情况很差
• Lack of process validation since 2011 自2011年以来无工艺验证
• Lack of cleaning validation of product equipment 产品设备无清洁验证
• Partly missing long-term stability studies长期稳定性研究部分缺失
• Batch Record entries are sometimes not made by the production employee who carried out the activity, but by the head of production at a later date 批记录录入数据有时并不是由执行该操作的生产部员工记录，而是生产主管后期录入
  
  

The most impressive (or shocking) sentence, however, is"lack of competent personnel in departments of QA, Production, QC,Engineering". This raises the question whether any of the GMP-regulatingunits employ competent personnel. It does not seem to be the human resourcesdepartment.

最令人印象深刻（或者说是令人震惊）的句子是“QA部门、生产部门、QC和工程部门缺乏具备资质的人员”。这就引发了GMP相关部门是否聘用具备资质人员的问题。看起来并不是人事部门的问题。

This is correlated by the observation of the lack oftraining of key personnel.

这与缺乏关键人员培训的缺陷相对应。

The Romanian pharmaceutical company concerned may be relatively small and no large International Corporation, but the deficiencies are still alarming. Especially because the job market is empty of professionals with GMP experience (this is as true for Romania as it is for the rest of Europe), companies should once again build on long-term strategies for personnel development, as was customary in the 1970s and 1980s. The training ofnew employees by the "old hands" cannot be accomplished on the side,especially because this may take up to five years. In any case, the Romanian drug manufacturer has lost its manufacturing authorisation for now.

该罗马尼亚制药公司可能规模相对较小，并非大型国际化公司，但这些缺陷仍然令人警醒。尤其是因为人力资源市场上缺乏具备GMP经验的专业人员（这是也罗马尼来的现实问题，因为这是在东欧），公司应再次构建长期的人员发展策略，如70年代和80年代情况一样。“老手”对新员工的培训无法完全满足要求，尤其是这可能会需要5年之久。无论如何，罗马尼亚药品生产商现在已丢掉了其生产许可证。

The Non-Compliance Statement from 23 June, 2017 can befound in the EMA's EudraGMDP database.

zysx01234

这个公司管理水平也够低的，跟我们国内很多带着药业二字的小厂很类似，死有余辜

beiwei5du

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预知子

zysx01234 发表于 2018-3-8 09:17
这个公司管理水平也够低的，跟我们国内很多带着药业二字的小厂很类似，死有余辜

是的，“死有余辜”这个词好

zysx01234

linbinbin 发表于 2018-3-8 10:43
是的，“死有余辜”这个词好

我是搞GMP质量体系的，对于搞敷衍应付的企业是深恶痛绝的。

他们应该解放思想、科学管理、有效投入、持续改进。这里的有效投入，也有持续和科学投入的意思。

一沙一叶

是不是欧洲美国只会盯着印度中国啊