【正文】 A (USP 2022a). Stage6A:REGIONAL ADOPTION ? USP31 General Information/1196 Phmarmacopeial Harmonization: The following policy statement was approved by the PDG at its September 2022 meeting. Table2. Status of HarmonizationGeneral Chapters Tests for specified microanisms EP Stage4 Microbial Enumeration EP Stage4 Microbial Attributes EP Stage4 Stage4:Official Inquiry 中國藥品生物制品檢定所 8 Harmonization(USP/EP/JP): Microbiological Examination of Nonsterile Products USP31 Guide to General Chapters/Chart10 As of May1,2022 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 Microanisms will bee official. Also on May1,2022,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. This general chaper presents 2 sets of tests. The 1st set gives the reference methods for determining pliance with monographs. Reference to this chapter in a monographs therefore implies pliance with the 1st set of tests, unless use of the 2nd set of tests has been authorised. The tests in the 2nd set also constitute official methods of the EP and may be refered to as such, notably in applications for marketing authorisation. It is intended to replace the 1st set by the 2nd set once the monographs concerned have been revised. The 2nd set presents tests developed in cooperation with the JP and USP to achieve harmonised requirements. 中國藥品生物制品檢定所 9 Harmonization(USP/EP/JP): Microbiological Examination of Nonsterile Products USP EP 61Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 62 Microbiological Examination of Nonsterile Products: Tests for Specified Microanisms Microbiological Examination of Nonsterile Products: Tests for Specified Microanisms 1111 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use Microbiological Quality of Nonsterile Pharmaceutical Products Harmonization Timing/Issues EP:2022/01 USP:2022/05 JP:2022/10 中國藥品生物制品檢定所 10 方法和標準的修訂與完善 2022年版 《 中國藥典 》 微生物限度檢查法 附錄 XIII C（一部） 附錄 XI J （二部） ?引入培養(yǎng)基適用性實驗 ?增加白色念珠菌檢查法 ?貼膏劑檢查方法的改進 ?限度標準表示方法改變 中國藥品生物制品檢定所 11 方法和標準的修訂與完善 2022年版 《 中國藥典 》 微生物限度檢查法 附錄 XIII C（一部） 附錄 XI J （二部） ?引入培養(yǎng)基適用性實驗 ?增加白色念珠菌檢查法 ?貼膏劑檢查方法的改進 ?限度標準表示方法改變 中國藥品生物制品檢定所 12 2022年版微生物限度檢查法修訂 附錄 107頁，微生物限度檢查法 供試品檢查時，如果使用了表面活性劑、中和劑或滅活劑，應證明其有效性及對微生物（的生長和存活無影響）無毒性。 除另有規(guī)定外 ， 本檢查法中細菌及控制菌培養(yǎng)溫度為 30～ 35℃ ；霉菌 、 酵母菌培養(yǎng)溫度為 23～28℃ （ ；控制菌培養(yǎng)溫度為 35～ 37℃ ） 。 中國藥品生物制品檢定所 14 2022年版微生物限度檢查法修訂 附錄 107頁，膜劑供