被检查公司：HYPERION SA

检查机构：罗马尼亚药监局

缺陷内容：

• The company was not able to provide an adequate CAPA

   该公司难以提供充分的CAPA

• 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-regulating units employ competent personnel. It does not seem to be the human resources department.

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。

insufficient training of the key personnel, especially having regard the long history of weak GMP compliance of this manufacturer; certain major deficiencies remained unsolved since previous inspections and other deficiencies reoccurred, although were declared solved in 2015;

关键人员培训不足，尤其是该公司长期不符合GMP，主要缺陷自上一次检查以来一直没有解决，还爆发了其他缺陷，但是对外声明说2015年的时候已经解决了。