欧盟GMP附录1

欧盟GMP附录1-无菌药品生产

EUROPEAN COMMISSION

ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals

Brussels, 25 November 2008 (rev.)

EudraLex

The Rules Governing Medicinal Products in the European Union

Volume 4

EU Guidelines to

Good Manufacturing Practice

Medicinal Products for Human and Veterinary Use

Document History

Previous version dated 30 May 2003, in operation since

Revision to align classification table of clean rooms, to include

guidance on media simultations, bioburden monitoring and capping

of vials Date for coming into operation and superseding

September 2003 November 2005 to December 2007 01 March 20091

Please note correction on the implementation of provisions for capping of vials!

1 Note: Provisions on capping of vials should be implemented by 01 March 2010.

Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium. Telephone: (32-2) 299 11 11