20150325 ECA新闻：EU委员会签发2份指南终版：辅料GMP和原料药GDP - 药群论坛

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015225111928446/

GMP News
25/03/2015

http://www.gmp-compliance.org/enews_4783_EU-Commission-issues-two-final-Guidelines-GMP-for-Excipients-and-GDP-for-APIs_9343,9188,S-QSB_n.html

EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs

EU委员会签发2份指南终版：辅料GMP和原料药GDP

After nearly two years of consultation, the European Commission has published two important and long-awaited guidelines in the official journal of the European Union, edition 21st March 2015:

在征求意见近2年后，欧洲委员会在欧盟官方杂志2015年3月21日的版面上公布了2份重要的期待已久的指南：

The "guidelines on the principles of good distribution practice for active substances of medicinal products for human use" and
人用药原料药GDP原则指南
The "formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use"
人用药所用辅料GDP确定的正式风险评估

Both guidelines were already published as draft documents on 6th February 2013 on the News page of the European Commission (Pharmaceutical Archives - 2012), and they were open for comments until 30th April 2013.

2份指南草案均已在2013年2月6日“欧洲委员会新闻页（药品归档2012）”上公布，征求意见直至2013年4月30日。

Both guidelines are considerably more detailed in their present form and contain more stringent requirements than the respective drafts. For instance, as part of the risk assessment for pharmaceutical excipients the supply chain including cold chain management, the stability of the excipient and the suitability of the packaging have to be evaluated.

2份指南终版详细了许多，包含的要求比相应的草案更严格。例如，作为药用辅料的风险评估的一部分，供应链包括冷链管理，辅料的稳定性和包装的持久性必须进行评估。

The requirements with regard to the quality assurance system of distributors for APIs are also much more detailed and demand the tracking and documentation of deviations and a CAPA system.

关于原料药分销商的质量保证体系的要求也更详细，要求对偏差进行追踪和记录，并要求具备CAPA体系。

The guidelines on GDP for APIs are also relevant for the national authorities as they are a further specification of the provisions laid down in part II of the EC GMP Guide.

原料药GDP指南也与国家药监局相关，因为它是对欧盟GMP指南第二部分中条款的详细说明。

A more detailed analysis of the two documents will be issued in the next newsletters.

关于2份指南文件的更详细分析将在下期快讯中发布。