欧盟GMP附件13：研发阶段药物的GMP更新!

Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium. Telephone: (32-2) 299 11 11 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceu ticals Brussels, 03 February 2010 ENTR/F/2/AM/an D(2010) 3374 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 Annex 13 Investigational Medicinal Products Document History Revision to reinforce the principle of independence between production and quality control functions in cases where the number of personnel involved is small. Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples given in Annex 19. An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC. The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public consultation, has been added as an attachment. A few editorial changes have been made to sections not consulted upon in the interests of updating references and consistency with terminology used throughout the GMP Guide. February 2008 Public consultation April 2008 until January 2009 Adopted by the European Commission 31 January 2010 Deadline for coming into operation 31 July 2010 PRINCIPLE Investigational medicinal products should be produced in accordance with the principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV). Other guidelines published by ...