20150204 印度制药厂分析结果造假

20150204 印度制药厂分析结果造假  

2015-02-05 22:16:25|  分类： FDA

原文网址：http://www.gmp-compliance.org/enews_04629_Falsified-Results-of-Analysis-at-Indian-Pharmaceutical-Manufacturer.html

Falsified Results of Analysis at Indian Pharmaceutical Manufacturer

印度制药厂分析结果造假

Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. We recently reported on theunannounced FDA inspections in India as one of the consequences of this practice. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. An employee of Sun Pharmaceutical Industries Ltd. in Vadodara, India simply deleted analytical data of an HPLC testing on impurities of an antibiotic that did not comply. The next day another sample was tested, considered to be fine and the batch was released. This incident took place three years ago.

印度制药厂由于违反GMP要求引起日益增加的关注。我们最近报告了FDA在印度进行飞行检查即是该问题引发的后果。又有一例由于分析结果不符合要求从而被删除，但该批产品仍被放行至美国市场。SUN PHARMA公司的一位员工简单地删除了HPLC中一个抗生素药品的杂质分析不合格数据。第二天，对另一份样品进行了测试，测试结果合格，该批次被放行。该事件发生在三年之前。

This fundamental GMP violation of data integrity has become known only now. The FDA's computer forensics experts found traces of a total of 5031 deleted data records in the chromatography system. A senior QC Manager commented that they often made pre-tests and rejected the results before starting the final analysis. This practice is completely inacceptable not only according to FDA understanding. The FDA talks about the regular deletion of undesirable analysis results and about retesting the products without initiating an investigation as required and without documenting the problem. And this is no isolated case.

这件根据违背GMP的数据完整性的事件现在才被发现。FDA的计算机物证专家发现在色谱色系中共有5031例数据记录被删除。一位资深QC经理评价说他们经常做预检测，然后扔掉这些结果，开始做最终检测。根据FDA的理解，这种操作规范是完全不被接受的。FDA谈到对非预期分析结果的常规性删除，以及没有启动调查就对产品进行复检，也没有记录这些问题，并且这都不是孤例。

Similar irregularities concerning the data integrity were found at the site of the Indian producer Ranbaxy who had to pay a penalty in the amount of 500 Mio US Dollars. A responsible at the Indian government announced that India has had good manufacturing practices for the manufacture of drugs for years but that the laboratory guidelines to manufacturers entered in force only in 2012. He continued that usually it would take some years for new regulations to be complied with nationwide. In the case described a ban on exports had been imposed against the company Sun already two months earlier. The underlying report by Bloomberg states that at least 12 Indian pharmaceutical companies were affected by such a ban on exports in the last year. One of these cases concerns the Indian company Smruthi Organics Ltd., for instance which also manufactures an antibiotic. During an FDA inspection the inspectors noticed already in 2013 that batches of active ingredients that did not comply with the specifications were blended with passing batches in order to meet the requirements (= missblending). The relating batch documents had been destroyed.

在印度RANBAXY公司也发现了类似的数据完整性不合规情况，该公司必须支付高达5亿美元的罚金。印度政府部门的一位负责人声称印度已建立药品生产GMP很多年了，但对生产商的化验室指南只是在2012年才开始生效。他还说，一般新的法规要在全国实施会需要许多年，而此前2个月SUN公司已经被禁止出口。BLOOMBERG一份含蓄的报告称，在去年就有12家印度制药公司受到出口禁令的影响。其中一个案例是印度SMRUTHI ORGANICS公司，他们正好也生产一种抗生素药品。在2013年的一次FDA检查中，检查官注意到有一批不符合质量标准的原料药被与合格的批次在一起混合以达到质量标准（=错误混合）。相关批次的文件被销毁了。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720151595151587/

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