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被檢查公司：HYPERION SA

檢查機構(gòu)：羅馬尼亞藥監(jiān)局

缺陷內(nèi)容：

• The company was not able to provide an adequate CAPA

   該公司難以提供充分的CAPA

• No records for use of primary reference standards

  無基準對照品使用記錄

• No raw data of integrity and identity testing (of starting materials and finished products) available 

  無（起始物料和制劑）完整性和鑒別試驗原始數(shù)據(jù)

• No checks of the log-books in the laboratory 

  對化驗室日志無檢查

• No records of the media preparation in the microbiology laboratory 

  微生物化驗室的培養(yǎng)基制備無記錄

• No checks of the data entered into the Certificate of Analysis

  錄入COA的數(shù)據(jù)無檢查

• Errors and deficiencies     in the sampling documentation

  取樣文件記錄中有錯誤和缺陷

• Alterations of data in the log-book and     obliteration of former entries; failure to mention the person who made the changes 

  修改日志中的數(shù)據(jù)，涂去原錄入；未提及修改人

• Poor conduct of qualification and validation

  確認和驗證執(zhí)行情況很差

• Lack of process validation since 2011

  自2011年以來無工藝驗證

• Lack of cleaning validation of product equipment 

  產(chǎn)品設(shè)備無清潔驗證

• Partly missing long-term stability studies

  長期穩(wěn)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

  批記錄錄入數(shù)據(jù)有時并不是由執(zhí)行該操作的生產(chǎn)部員工記錄，而是生產(chǎn)主管后期錄入

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（或者說是令人震驚）的句子是“QA部門、生產(chǎn)部門、QC和工程部門缺乏具備資質(zhì)的人員”。這就引發(fā)了GMP相關(guān)部門是否聘用具備資質(zhì)人員的問題?？雌饋聿⒉皇侨耸虏块T的問題。

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

這與缺乏關(guān)鍵人員培訓(xùn)的缺陷相對應(yīng)。

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;

關(guān)鍵人員培訓(xùn)不足，尤其是該公司長期不符合GMP，主要缺陷自上一次檢查以來一直沒有解決，還爆發(fā)了其他缺陷，但是對外聲明說2015年的時候已經(jīng)解決了。