EU-GMP指南清单.doc

EU GMP指南清单 Volume 4 of The rules governing medicinal products in the European Union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. 分类 名称 适用部门 EudraLex - Volume 4 GMP guidelines Introduction Introduction (7/02/2011) Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human useReplacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products. 棗 C Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. 棗 C Part I - Basic Requirements for Medicinal Products Chapter 1 Quality Management (revision February 2008) - Coming into operation by 01 July 2008 Previous version (revision October 2005) (add “Product Quality Review”) Previous version 1998 QA、QC、生产 Chapter 2 Personnel 200408Previous version 1998 所有部门 Chapter 3 Premise and Equipment 1998 工程、设备、QA Chapter 4 Documentation (Revision January 2011) - Coming into operation by 30 June 2011Previous version 200408 Previous version 1998 QA Chapter 5 Production 1998 生产、QA Chapter 6 Quality Control (revision October 2005)“On going Stability”) Previous version 200408 Previous version 1998 QC、QA Chapter 7 Contract Manufacture and Analysis 1998 生产、QC、QA Chapter 8 Complaints and Product Recall (revision December 2005)Previous version 1998 QA Chapter 9 Self Inspection 1998 QA Part II - Basic Requirements for Active Substances used as Starting Materials Basic requirements for active substances used as starting materials (January 2010) The revised part II wil