斯洛文尼亚GMP检查员的GMP检查报告导致FDA和加拿大药监进口禁令？

20151007 ECA新闻：斯洛文尼亚GMP检查员的GMP检查报告导致FDA和加拿大药监进口禁令？  

Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?
斯洛文尼亚GMP检查员的GMP检查报告导致FDA和加拿大药监进口禁令？
In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. The Inspectors found 17 GMP deviations of which 5 were rated major. The combination of theses major deviations represents a critical deficiency leading to a potential risk for patients. This has caused a GMP Non-Compliance Report in EudraGMDP and the suspension of all CEPs of the company. The Inspectors have requested the marketing authorisation holders using APIs from Polydrug Laboratories to change their API supplier. Please read our GMP News about the GMP Inspection at Polydrug for more details.
2015年3月，斯洛文尼亚GMP检查官对印度马哈拉施特拉邦的POLYDRUG进行了GMP检查。检查员发现17个GMP偏差，其中5个被认为是主要缺陷。这些主要偏差一起表示一个关键缺陷，导致对患者具有潜在风险。这引起了EUDRAGMDP上的GMP不符合报告，以及该公司所有CEP被搁置。检查员要求使用POLYDRUG公司原料药的上市许可持有人更换其原料药供应商。更多细节参见“POLYDRUG的GMP检查新闻”。
Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Already in June Health Canada have issued a press release in which they requested Canadian importers to voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns.
现在看来，加拿大药监和美国FDA使用了斯洛文尼亚的这份GMP检查报告，决定对销往加拿大和美国的原料药也采取措施。在6月，加拿大药监已签发了通知，其中要求加拿大进口商“主动扣留采用马哈拉施特拉邦PLYDRUG公司生产或测试的原料药生产的制剂，因其存在数据完整性问题”。
Now also FDA has issued an Import Alert. Products manufactured by Polydrug can no longer enter the US market due to serious GMP violations. There is no concrete evidance that the EU Inspections by the Slovenian Authority is the only reason for the actions by Health Canada and US FDA. But it is very likely that the EU Inspection has been the initial trigger for actions taken by Canada and US.
现在FDA也签发了进口禁令。POLYDRUG生产的产品不能再进入美国市场，因为存在严重的GMP违规问题。并没有确切的证据表明斯洛文尼亚药监局实施的EU检查是加拿大药监局和美国FDA采取措施的唯一原因，但很可能EU检查是其采取措施的导火索。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720159804649499/

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