EU GMP 附录1：EMA计划修订其无菌指南

20150212 ECA新闻：EU GMP 附录1：EMA计划修订其无菌指南  

2015-02-13 19:06:43|  分类： ECA新闻

GMP News
12/02/2015

http://www.gmp-compliance.org/enews_04706_EU-GMP-Annex-1-EMA-plans-the-Revision-of-the-Sterile-Guide.html

EU GMP Annex 1: EMA plans the Revision of the Sterile Guide

EU GMP 附录1：EMA计划修订其无菌指南

At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. The reasons given for the revision are technological developments as well as the adaptation to the ICH Q9 and Q10 guidelines. The last, relatively extensive revision of Annex 1 dates back to 2007. The new version of Annex 1 should also include new technologies in sterile production - not previously covered - beside the adaptation mentioned.

在2015年2月初，EMA公布了关于附录1修订版本的概念文章。EU GMP指南的附录1是欧洲关于无菌药品的生产要求指南。修订的原因是技术的发展，以及对ICH Q9和Q10的采用。上次对附录1进行大面积修订还是在2007年。-除上述修订内容外，新的附录1版本还将包括无菌生产的新技术。

The paper contains a very interesting paragraph which describes the necessity of a change if there is a revision of a pharmacopoeia monograph. Here, the method for the production of WFI (water for injection) without distillation is mentioned. This is all the more interesting as there is currently no information from the EDQM - the editor of the European Pharmacopoeia - that a change to this method is planned soon. So far, distillation only is allowed for the production of WFI according to the European Pharmacopoeia.

该文章包含了一个非常有意思的段落，其中描述了如果药典各论修订时变更的必要性。这里，提到了不采用蒸馏方法生产注射用水（WFI）的方法。这非常有意思，因为目前EDQM（欧洲药典的编写方）还没有相关的信息说明该方法将很快进行变更。到目前为止，根据欧洲药典，只有蒸馏是唯一允许的WFI生产方法。

You can find the Concept Paper on the EMA webpage. The consultation deadline ends on 31 March 2015.

该概念文章可以在EMA网站上找到。征求意见的截止时间为2015年3月31日。

The revision of Annex 1 will also be a topic of the Pharma Congress on 24-25 March 2015 in Düsseldorf, Germany. There, Dr Jean-Denis Mallet - former head of the French GMP inspection authority - will give a Key-Note presentation on 24 March about the changes required to the most significant paper on sterile production.

附录1的修订也会是2015年3月24-25在德国杜塞尔多夫举办的药学会议上的一个议题。届时，法国GMP检查局的前领导Dr Jean-Denis Mallet将在3月24日针对关于无菌生产中最重要文件所需变更的演讲。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201511393419253/

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