中国药典2010年版微生物限度检查及发展趋势J-马2.ppt

中国药典2010年版微生物限度检查及发展趋势 中国药品生物制品检定所 马仕洪 2010年5月26日 上海 无菌/微生物限度检查理念 微生物限度检查现状与发展趋势 1、方法和标准的修订与完善 2、技术现状与标准化 3、微生物限度检查的几个问题 4、微生物限度检查法应用指导原则 5、抑菌效力检查法指导原则 6、药品微生物检验替代方法验证指导原则 7、药品微生物实验室规范指导原则 1、方法和标准的修订与完善 表8 中国药典2005版微生物限度检查法与英美药典比较 总需气菌、霉菌及酵母菌计数 对供试品的前处理和一些检验方法进行了完善； 具有明显的中国特色，与国际差距显著。 计数测定体系的差异： 难以操作，检验繁琐 需气菌总数=细菌数+霉菌及酵母菌？ 1000 1000 100 参见：《美英欧药典微生物限度标准的浅析》，苏德模、胡昌勤、马越，《中国药品标准》，2005年第3期 Harmonization(USP/EP/JP):Microbiological Examination of Nonsterile Products The USP and the EP Microbial Limits Tests are in the final stages of harmonization.They were signed off to Stage6A at the November,2005 meeting of the PDG held in Chicago,IL USA (USP 2006a). Stage6A:REGIONAL ADOPTION USP31 General Information/1196 Phmarmacopeial Harmonization: The following policy statement was approved by the PDG at its September 2002 meeting. Table2. Status of Harmonization-General Chapters Tests for specified microorganisms EP Stage4 Microbial Enumeration EP Stage4 Microbial Attributes EP Stage4 Stage4:Official Inquiry Harmonization(USP/EP/JP):Microbiological Examination of Nonsterile Products USP31 Guide to General Chapters/Chart10 As of May1,2009 chapter61Microbial Limits Tests will be replaced by 61 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests,and the new chapter 62 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms will become official. Also on May1,2009,Chapter1111 Microbial Attributes of Nonsterile Pharmaceutical Products will be replaced by 1111 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. EP6.0 2.6.12/2.6.13/5.1.4 This general chaper presents 2 sets of tests. The 1st set gives the reference methods for determining compliance with monographs. Reference to this