大面积数据篡改：FDA给欧洲药品生产商的新警告信

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[size=15.5556px]GMP News

[size=15.5556px]16/11/2016

[size=15.5556px]Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

大面积数据篡改：FDA给欧洲药品生产商的新警告信

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在其过往检查中，通常会在远东发现数据完整性不足的缺陷。现在欧洲生产场所也无法幸免。最近发布的一封警告信是给捷克INTERPHARMPRAHA公司的，其中指出了大量的原料药和制剂检测方面质量控制领域的缺陷。

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.

基本上来说，化验员对HPLC系统拥有对数据处理的全部权限，因而，化验室用了这些权限进行了大面积的“手动”积分，从序列中删除或增加样品。这些篡改行为在审计追踪中一览无余：在约9000条记录中，有超过5000条是追踪到数据删除，对峰进行手动积分等。在FDA检查人员的要求下，化验室员工指出这种做法很普遍。

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.

对数据进行如何美化的原因之一也是由于色谱系统无法对峰面积执行正确的积分。FDA检查员找出了一部分峰积分不完整或缺失的情况，得出结论是系统完全不足以用于既定用途。因此批放行决策是基于不完整的数据，这可真是个令人悲伤的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.

在警告信的结尾，FDA给出了一个措施清单。如果该公司仍然想要将其产品出口销售到美国市场，那就需要满足这些要求。

For further details please see the [size=15.5556px][url=]FDA\'s Warning Letter issued to Interpharm Praha[/url].

更详细信息，参见FDA警告信。