PHARMACEUTICAL INSPECTION CONVENTION（药品检验公约）.doc

MEDICINES CONTROL COUNCIL GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES IN SOUTH AFRICA This document has been prepared to serve as a guidance document on the requirements for Good Manufacturing Practice applicable to the manufacturing of medicines. It is not intended as an exclusive approach. Council reserves the right to request for any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data accompanying applications for registration of medicines. Alternative approaches may be used but these must be scientifically and technically justified. The MCC is committed to ensure that all medicines gaining market approval will be of the required quality, safety and efficacy. This Guide is based entirely on the “Guide to Good Manufacturing Practice for Medicinal Products”, version PE 009-2 dated 1?July 2004 published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The modifications to that Guide and its adoption as the South African Guide to Good Manufacturing Practice is done so with the expressed permission of the PIC/S. Version 1 - Implementation 1997 Version 1 - Chapter 9 (Validation) reformatted January 2004 Version 2 - Sept 2005 adopted PIC/S GMP Guide of July 2004 - Implementation January 2006 Version 3 - Sept 2008 update to amend Introduction and include requirements for Quality Product Review (1.5) , Risk Management (1.6), On-going stability programme (6.7), Analytical Method Validation (Annex 15 15.7) and Glossary, keeping of Reference and Retention samples (Annex 19), Quality Risk Management (Annex 20) September 2008 Version 4 - March 2009 update to amend Radiopharmaceuticals (Annex 3), Herbal Medicinal Products (Annex 7) March 2009 Due date for comment Version 3 31 January 2009 Due date for comment Version 4 30 June 2009 Version 5 (consolidates comments on versions 3 and 4) - Implementation 1