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Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

大面積數(shù)據(jù)篡改：FDA給歐洲藥品生產(chǎn)商的新警告信

During its inspections, the FDA has been observing insufficient data integrity quite often in the Far East. Now, European production sites are not always exemplary. A Warning Letter recently published for the Czech Company Interpharm Praha describes considerable deficiencies in the area of quality control with regard to API and finished products testing.

FDA在其過往檢查中,，通常會在遠東發(fā)現(xiàn)數(shù)據(jù)完整性不足的缺陷?，F(xiàn)在歐洲生產(chǎn)場所也無法幸免。最近發(fā)布的一封警告信是給捷克INTERPHARM PRAHA公司的,，其中指出了大量的原料藥和制劑檢測方面質(zhì)量控制領(lǐng)域的缺陷,。

Basically, the personnel of the analytical laboratory had full access to the data processing of the HPLC- system. Accordingly, the possibility to delete data, to integrate peak areas 'by hand' and to eliminate or add samples from sequences was used extensively. These manipulations were visibly clear in the audit trail: among the round 9,000 entries, more than 5,000 actions were traced as data deletion, manual integration of peaks, etc. At the FDA inspectors' request, the employees of the laboratory indicated that such actions are common.

基本上來說，化驗員對HPLC系統(tǒng)擁有對數(shù)據(jù)處理的全部權(quán)限,，因而,，化驗室用了這些權(quán)限進行了大面積的“手動”積分，從序列中刪除或增加樣品,。這些篡改行為在審計追蹤中一覽無余：在約9000條記錄中,，有超過5000條是追蹤到數(shù)據(jù)刪除，對峰進行手動積分等。在FDA檢查人員的要求下,，化驗室員工指出這種做法很普遍,。

One of the reasons why data had been beautified in such a way is also due to the fact the chromatographic system was not able to execute correct integration of peak areas. The FDA inspector identified partly incomplete or missing integrations of peaks and concluded that the system was wholly inadequate for the purpose. Batch release decisions were thus based on incomplete data, which is a grave GMP-deficiency.

對數(shù)據(jù)進行如何美化的原因之一也是由于色譜系統(tǒng)無法對峰面積執(zhí)行正確的積分。FDA檢查員找出了一部分峰積分不完整或缺失的情況,，得出結(jié)論是系統(tǒng)完全不足以用于既定用途,。因此批放行決策是基于不完整的數(shù)據(jù)，這可真是個令人悲傷的GMP缺陷,。

At the end of the Warning Letter, a list of measures is included for the company to fulfil if it still wants to distribute its products on the US American market.

在警告信的結(jié)尾,，F(xiàn)DA給出了一個措施清單。如果該公司仍然想要將其產(chǎn)品出口銷售到美國市場,，那就需要滿足這些要求,。

For further details please see the FDA's Warning Letter issued to Interpharm Praha.

更詳細信息，參見FDA警告信,。