FDA/EU-GMP矩阵全面修订

一沙一叶

                                                                   FDA/EU-GMP矩阵全面修订

                                                     ECA新闻

    特别是对于跨国制药公司，经常会面临着这样的问题：关于医药产品的US的cGMP (21 CFR 211)和EU GMP指南有什么区别，有什么并行的地方？关于医疗器械-例如组合产品-还有另外一个问题：如何能让ISO9001适应这些药品法规？

   为了支持回答这些问题，ECA在多年前发布了一份GPG（它的GMP矩阵）。关于21CFR211，这个矩阵比较了EUGMP指南PART1（1-9章）和ISO 9001:2008。这份比较进一步延伸，还比较了ICHQ10和ISO9001。为了使可读性更强，文本被压缩到最少，比较也集中在单个段落的特别的内容。为了能够逐字逐句的比较，所有相关法规都包括在手册当中。

    这样使这个手册成为一个可以常用于审计中的质量保证工具，特别对于跨国公司。它也可以用于USA和欧洲的GMP世界的“差距分析”。

    根据第三章、第五章和第八章的变化，这类矩阵也需要被采用。在这些修订的章节在2015.03.01生效的同时，这个矩阵也重新更新，第17版本可以应用。可以通过ECA网站购买。

      这次全面修订使GMP矩阵成为了一个比较USA和欧盟“GMP世界”的简洁纲要，因此是审计人员的一个有用的QA工具。对于ISO 9001:2008 的比较进一步区分了这些更特别的法规的不同之处，这样对组合产品的生产商和供应商更有用。

Especiallyglobally operating pharma companies frequently face the question whatdifferences there are between the US cGMP regulations (21 CFR 211) and the EUGMP Guide for Medicinal Products - and what parallels there are? And with regard tomedical devices - e.g. Combination Products - there is an additional question:How does the ISO 9001 still fit in these pharma specific regulations?

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To support you in answeringthese questions, the ECA Academy has developed a Good Practice Guide (its"GMPMatrix") years ago. With reference to 21 CFR211 this Matrix compares the EU GMP Guide, Part I (Chapters 1-9) and the ISO9001:2008. This comparison is further extended by anadditional matrix comparing the ICH Guide Q10 with the ISO 9001. Forbetter readability of the tables the text is reduced to a minimum, and thecomparisons concentrate on single paragraphs resp. chaptersand sub-chapters with their particular items. To possibly be able to compare word by word allrelevant regulations are included in the brochure.

This makes the brochure a realhandbook which is frequently used as a quality assurance tool in audits, especiallyin globally operating companies (see also the GMP News from 10 October 2012"GMP Matrix as Standard for Audits in many Companies"). It can also be used for a"GAP analysis" when moving between the "GMP worlds" USA andEurope. And it further shows wherethe GMP regulations are more specific in comparison with ISO 9001.

Due to the changes in Chapters 3 and 5 (please see also GMP Newsfrom 12 February 2015 "EU issues new Version of GMP Guide Chapters 3 and5") as well as in Chapter 8 (please see GMP News from 23 September 2014"Complaints and Recalls: new EU-GMP Chapter 8 published") the Matrixalso had to be adapted. Just on time with the validity date 1 March 2015of the revised chapters the Matrix is up-to-date again and available in version17. It canbe purchased via the ECA Academy website - charges for ECA members are 99,-EUR, for non-members 149,- EUR.

PLEASE NOTE:As a delegate of the 6th European GMP Conference, scheduled in Heidelberg,Germany, from 9-10 June, you will receive the GMP Matrix as a free of chargeadd-on. As organiser of thisbiennial Conference it is the ECA's goal to contribute to the harmonisation ofGMP. And theGMP Matrix is a major contribution in these harmonization effort.

The comprehensive revision makes the GMP Matrix a compactcompendium comparing the two "GMP worlds" USA and Europe, and is thusa very helpful QA tool for auditors. The additional comparisonwith the ISO 9001:2008 further provides indications where the GMP regulationsare more specific, making it helpful for manufacturers of Combination Productsor suppliers.

syhorchid

了解一下

凯博思咨询

矩阵没图啊？

一沙一叶

凯博思咨询 发表于 2015-3-12 23:07
矩阵没图啊？

人家要收费  

凯博思咨询

一沙一叶 发表于 2015-3-12 23:09
人家要收费

你自己画一个，比着葫芦画个瓢

凯博思咨询

一沙一叶 发表于 2015-3-12 23:09
人家要收费

你自己画一个，比着葫芦画个瓢

凯博思咨询

一沙一叶 发表于 2015-3-12 23:09
人家要收费

你自己画一个，比着葫芦画个瓢

jiangboren4758

了解一下

郦无悔

@一沙一叶 现在洛施德在组织众筹购买和翻译呢,

一沙一叶

郦无悔 发表于 2015-3-13 09:12
@一沙一叶 现在洛施德在组织众筹购买和翻译呢,

我今天才看到，她一个咨询公司还要搞众筹，真是精打细算