欧盟药监恢复兰伯西TOANSA工厂的GMP证书

一沙一叶

   EU Authorities Lift GMP Suspension at Ranbaxy’s Toansa Site

                   欧盟药监恢复兰伯西TOANSA工厂的GMP证书

June 06, 2014 By contractpharma

Tag: FDA , GMP , ranbaxy



European regulatory authorities have finalized an assessment of reported non-compliance with GMP at Ranbaxy Labs’ manufacturing site in Toansa, India. While the assessment showed a number of GMP deficiencies at the site, European regulators concluded that there has been no risk to public health from these deficiencies. European regulators reviewed the corrective measures put in place by the company and found them to be sufficient to ensure GMP compliance, and, as a result, will reinstate the GMP certificate that was suspended in January 2014.  

欧洲法规当局已经完成了对兰伯西公司在印度TOANSA的工厂生产不符合GMP的评估。评估显示该工厂存在大量GMP缺陷，欧洲法规当局的结论是这些缺陷对公众健康没有造成风险。欧洲法规当局审核了该公司所实施的纠正措施，认为这些措施足以保证GMP符合性，因此，将恢复2014年1月搁置的GMP证书。

The assessment followed an inspection by the FDA, which revealed areas of non-compliance at the site. The European medicines regulatory network responded to the FDA’s findings, sending a team of inspectors from Germany, Ireland and the UK, along with inspectors from Switzerland and Australia to undertake an international inspection of the site.

上述评估是在FDA对上述工厂的检查后进行的。FDA检查揭示该工厂不符合GMP。在获知FDA发现的缺陷后，欧洲药品法规网络派遣了德国、爱尔兰和英国检查官组成的检查团，会同瑞士和澳大利亚检查官对上述工厂进行了国际检查。

The inspection team concluded that medicines on the EU market that have an API manufactured in Toansa were of acceptable quality presented no risk to patients. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.

检查团得出结论是，在欧盟市场上的TOANSA工厂生产的原料药质量可以接受，对患者没有风险。对这些药品的样品检测全都符合正确的质量标准，这也支持了该结论。

European regulatory authorities will continue to monitor the Toansa site in collaboration with India and other regulatory authorities.

欧洲法规当局将联合印度和其它法规当局继续TOANSA工厂进行监控。

幻影

整改通过。

wangjin1023

很难得的

一沙一叶

这个要继续关注，竟然能够整改通过。

syhorchid

GMP缺陷纠错

chenheshan

这就叫经得起检查。