EU签发新版GMP指南第3章和第5章

20150212 ECA新闻：EU签发新版GMP指南第3章和第5章  

2015-02-13 19:07:18|  分类： ECA新闻|

GMP News
12/02/2015

http://www.gmp-compliance.org/enews_04695_EU-issues-new-Version-of-GMP-Guide-Chapters-3-and-5.html  

EU issues new Version of GMP Guide Chapters 3 and 5

EU签发新版GMP指南第3章和第5章

The EU has re-published the recently revised Chapter 3 and Chapter 5 (we reported) and has made modifications regarding the transition period for the introduction of toxicological evaluations of products in multipurpose facilities. The two new documents carry the date 23 January 2015. The date of validity remains the 1 March 2015. The document now comprises a description of a stepwise procedure for the introduction of a risk management system to evaluate whether products need to be manufactured in dedicated or can be manufactured in multipurpose facilities. The procedure matches with that of the associated EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". That means that starting with the 1 June 2015 the new requirements are valid for new products which are evaluated regarding the manufacture in dedicated or multipurpose facilities for the first time. For products already manufactured in multipurpose facilities the new regulations are valid from 1 December 2015.

EU刚刚重新公布了现行修订后GMP指南第3章和第5章（我们报道过），对其进行了修订，加入了关于引入共线设施中产品毒性评估的过渡期条款。两份新的章节发布日期为1月23日是，生效日期仍为2015年3月1日。文件中现在增加了引入风险评估的分步程序描述，对产品是否需要在专用线生产，还是可以在共用设施中生产进行评估。该程序符合EMA“共用设施生产不同药品的风险识别中使用的基于健康的暴露限设定指南”。这表示从2015年6月1日开始，新的要求对首次评估是否需要专用线还是可以使用共线生产的新药品开始生效。对于已经在共用设施中生产的药品，新的法规将从2015年12月1日开始生效。

Hence the EMA Guideline is now explicitly mentioned, even if only in footnote 1 of the new chapters. In the draft of the two chapters this reference was still included, in the final versions references to the EMA Guideline were completely omitted.

这样，在GMP指南更新的章节中明确提到了EMA指南，虽然只是在脚注1。在两个章节的草案中，还包括了该引用，但在最终版本中，则完全省略了对EMA指南的引用。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201511393520481/

感谢分享，辛苦