欧盟灭菌方法选择决策树介绍.pdf

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 5 April 2000 CPMP/QWP/054/98 Corr COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) DECISION TREES FOR THE SELECTION OF STERILISATION METHODS (CPMP/QWP/054/98) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96) DISCUSSION IN THE QUALITY WORKING PARTY October 1997 January 1998 TRANSMISSION TO THE CPMP January 1998 RELEASE FOR CONSULTATION January 1998 DEADLINE FOR COMMENTS July 1998 ADOPTION BY CPMP February 1999 DATE FOR COMING INTO OPERATION August 1999 Background: These decision trees are intended to assist in the selection of the optimal sterilisation method and are proposed for inclusion as an annex to the Note for Guidance on Development Pharmaceutics. Reference is made to these Decision Trees in Section 5 (“Manufacturing Process”) of the Note for Guidance. Minor modifications/corrections made in April 2000 to clarify titles of Decision trees and use of term product / formulation as appropriate. 7 Westferry Circus, Canary Wharf, London E14