加拿大GMP检查数据库

julia朱玉姣

New comprehensive GMP InspectionDatabase available

新的综合性GMP检查数据库

Just recently a so called "inspection tracker" was launched by HealthCanada. Now, the agency offers an additional database which contains 3,821inspections (per March 2015) which have been performed since 2012 - many ofthem outside Canada, e.g. in Europe or Asia. The information is available in anonline database. The use of the database is very easy and search results areexcellent.

最近加拿大卫生局启动了所谓“检查追踪”的数据库。现在，官方提供另一个数据库，其中有3821条检查信息（2015年3月数据），这些检查是自2012年以来实施的，许多检查是发生在加拿大以外地区的，例如，欧洲和亚洲。信息可以从一个在线数据库中获得。该数据库使用非常简单 ，搜索功能非常好。

Byusing the database even inspections in progress can be displayed. This is aservice no other agency can provide. The database also offers furtherinformation about past inspections at the same production site. No furthersearch is necessary because the information about past inspections will bedisplayed in the search result for a given production site. The rating of theinspection is also provided, and in case of GMP non compliance a detailed andvery structured information about the findings is provided. The quality ofinformation about the outcome of the inspection available from thedatabase is outstanding. Again, no other agency worldwide isable not only to list the observations but also link them to the concreteGMP regulation paragraph in a structuredand numbered table.  

该数据库中甚至能显示出正在进行的检查。没有其它官方可以提供这样的服务。数据库还提供了关于同一受检生产场所过去的检查的更多信息。不需要进行高级搜索，因为关于过去检查的信息会在搜索指定的生产场所后就自动显示。它还提供了检查的分类，如果检查结果是GMP不符合，则会提供详细的组织很好的信息。从其中可以获得检查结果的信息质量也很高。同样，世界上没有哪个官方能够象这样不但列出缺陷，还将它们链接至组织好的编号表格中具体的GMP法规段落。

Thedatabase also provides information about past and present non-compliancesituations. However, it also shows when a company is currently licensed byHealth Canada, as the company possibly improved its GMP status and was licensedagain.

数据库还提供了关于过去和现在不符合性状态的信息。它还显示出一个公司何时获得加拿大卫生局的批准，因为公司可能会提高其GMP状态，重新获得批准。

Thedatabase allows three different options to search forinformation. The first option contains 1,301 Inspections (per March2015) from the past three years performed in Canada. A second optionallows to access the non-compliance information. Currently 52 production siteswith non compliance statements are listed in the database (some of the sitesreceived their license again after re-inspection). The third option offersaccess to 2,520 inspections (per March 2015) performed outside of Canada.

数据库还允许有3个不同选择来搜索信息。第一个选择包含1301个检查（2015年3月时数据），是过去3年在加拿大实施的检查。第二个选择可以获得不符合性信息。现在有52个生产场所被发布不符合性声明，列在数据库中（其中有些场所在重新检查后拿回来批准）。第三个选择可以获得2520个检查结果（2015年3月时数据），是在加拿大境外实施的检查。

Toaccess the database please visit Health Canada Drug & Health product Inspections Webpage

上述网址可以进入数据库。

毒手药王邓智先

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liwenxian

谢谢楼主分享，学习了。