报告GMP不合规的新网站

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报告GMP不合规的新网站

  不符合GMP要求的生产场地的信息是现在需要的内容。在全球化的世界范围内，生产场地往往不在药品销售市场所在地。医药产品和API生产都有复杂的生产供应链。今天，各个生产步骤发生在一连串的生产场地内。散装品生产在场地A，灌装并完成在场地B，内包装在场地C，外包装在场地D等。这个例子还是简单的-现实中远比这个复杂。因而对这些场地的监管对法规当局和制药企业都很重要。
   在过去，只有FDA通过公布场地的警告信提供关于GMP不合规方面的信息。另外，信息的自由允许接触到更多的细节，例如483表格或者EIR。后来，WHO开始发布关于场地的负面结果的报告。然而，到2015年3月5日，名单上只有两个生产场地，都在印度。
最后，欧盟开始建立了GMDP数据库来发布GMP和GDP的不合规报告。尽管，EudraGMDP已经是最广泛的服务，仍然还有很长的路要走。这个数据库设计的不好，而且可能无法一直按需工作。而且，不是所有的欧盟国家都能及时的把报告录入数据库。到2015.03.05，共有77份GMP不合规报告，以及2份GDP不合规报告。2014年1月公布了一份对于数据库列出的公司的分析。那时，GMP合规报告里面共有85个公司。
   加拿大卫生部是下一个对识别不符合GMP要求的信息的需求做出反应的当局。在新近公布的新的网页上，这个机构报告了他们的不合规检查结果。2015.02.27，“GMP检查追踪器”列举了15个严重违反GMP的生产场地。印度再一次在名单上名列榜首。加拿大目前没有合适的检查系统。只有少数制药生产场地被国内的当局检查。但是，在这相对少量的检查数量内，GMP不合规的数量很大。而且，缺陷非常严重，并且经常发现场地连基本GMP要求都满足不了。例如，生产数据（批记录，分析记录）被篡改，生产场地处于脏的条件（洁净室发现死虫子和霉菌）。现在15个不合规的生产场地名单中11个位于印度，2个在加拿大，2个在中国。


information about manufacturing sites that are out of GMP compliance is urgently needed. In a globalized world manufacturing is no longer located in the market where the medicinal products are sold. Complex manufacturing supply chains exist for both medicinal product and API manufacturing. Today, manufacturing steps take place in a long chain of production sites. Bulk manufacturing in site A, fill and finish in site B, primary packing in site C, secondary packaging in site D etc. And this example is an easy one - the reality is far more complex. The supervision of those sites is therefore of great importance for both authorities and pharmaceutical industry.

In the past only US FDA provided information about GMP non compliance by means of publishing Warning Letters on their website (see also the ECA Academy service of all GMP related Warning Letters). In addition the Freedom of Information Act allows to access more detailed information such as the Form 483 and the Establishment Inspection Report (EIR).

Later the WHO has started to issue their reports about negative findings on the webpage. However the current list as per 5th March 2015 only counts two manufacturing sites - both located in India (Notice of Concern by WHO) Finally the EMA has established theEudraGMDP Database with GMP and GDP non compliance reports.
Although EudraGMDP is already the most comprehensive service, there is still a long way to go. The database is not well designed and might not always work as needed. Moreover, not all EU Member States enter all their reports in the database in a timely manner. As per 5th March 2015 the EudraGMDP counted 77 sites with GMP non compliance reports and 2 with GDP non-compliance reports.
An analysis of the companies listed in the database was published in January 2014. At that time 85 companies were listed with GMP Compliance Reports
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. 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.

善变的云

制药企业必须十分关注，切莫踩红线喔。

jing2013b

板凳~~板凳~~~魔术杂技~~
中国企业技术好啊，换个地方就行了

郦无悔

沙老提供一下网址哦?