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加拿大GMP不符合信息站点

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电梯直达

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一场梦 发表于 2015-3-19 19:39:37 | 只看该作者回帖奖励

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加拿大GMP不符合信息站点

2015-03-19 07:07:49| 分类：加拿大

Health Canada is the next authority which reacts on the need for information to identify companies and sites that do not meet GMP standards. On the recently published new webpage the agency informs about their non-compliance findings.

加拿大卫生局对公众希望了解不符合GMP标准公司信息作出反应，最近公布了一个新的网页来传达其发现的GMP不符合情况。

On 27 February 2015 the "GMP Inspection Tracker" counted 15 manufacturing sites with serious GMP deviations. Again India takes a lead in this list. The country does not have an appropriate inspection system in place. Only a small number of the overall pharmaceutical manufacturing sites have been inspected by international authorities. But within this relative small number of sites (compared to the overall production in India) the number of GMP non compliant sites is enormous. Moreover, the findings are very critical and often sites have been found where even basic GMP standards have not been met. For example manufacturing data (batch records, analytical records) have been manipulated, production sites have been found in dirty conditions (even dead insects and mold have been found in clean rooms). The current list of 15 GMP non-compliant manufacturing sites counts 11 sites in India, 2 in Canada and 2 in China.

在2015年3月19日，共用15个生产场所被发现严重GMP严重违规。印度在其中又是拨得头筹，位列第一。其实国际药监机构所检查的药品生产场所只有很少的数量，但在这么小量（相对于印度总体生产规模）的场所中，GMP不符合的场所数量就很大。而且，发现的缺陷都非常关键，常常发现生产场所甚至不符合基本的GMP要求。例如，生产数据（批生产记录、批检验记录）是伪造的，生产场所非常脏（甚至发现昆虫尸体，在清洁区发现长霉）。目前列出的17个（1工厂的缺陷已关闭）GMP违规生产场所中，有12个是在印度的，2个在加拿大（1个已关闭），2个在中国，1个泰国。

以下为详细清单

1、印度Agila Onco Therapeutics Ltd.

2、印度 Apotex Pharmachem India Private Limited (APIPL)

3、印度 Apotex Research Private Limited (ARPL)

4、加拿大Attix Pharmaceuticals, Inc.

5、印度Cadila Pharmaceuticals Limited.

6、印度Dr. Reddy's Laboratories

7、印度IPCA Laboratories Ltd.

8、印度IPCA Laboratories Ltd

9、印度IPCA

10、印度Micro Labs Tamil Nadu

11、印度Micro Labs Goa