- 1、本文档共49页,可阅读全部内容。
- 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
0731生效欧盟GMP原料药
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Consumer goods
Pharmaceuticals
Brussels, 03 February 2010
ENTR/F/2/AM/an D(2010) 3374
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Part II: Basic Requirements for Active Substances used as Starting Materials
Document History
An amendment is made to Part II of the GMP Guide to incorporate
principles of Quality Risk Management in line with the ICH Q9
guideline on Quality Risk Management. Amendments correspond to
similar changes made to Part I Chapter 1 of the Guide and published
September 2007
in February 2008. A new section on Quality Risk Management is
introduced as section 2.19. The remaining sections of chapter 2 are
renumbered. A minor change is made to section 2.21. No other
changes have been made.
April 2008 until
Public consultation
October 2008
Adopted by the European Commission 31 January 2010
Deadline for coming into operation 31 July 2010
Commission Européenne, B-1049 Bruxelles / Europese Commissie,B-1049 Brussel – Belgium, Telephone: (32-2) 299 11 11
文档评论(0)