Differences in result interpretation for non sterile products according the EU, USA, J harmonization - Factor: Introduction of factor 2 instead of factor 5 - Recovery: result can be between half and twice of the inoculum - Monograph Product Specification: acceptance criterion 102 CFU maximum acceptable count = 200; minimum=50.The“Growth Promotion Test” requirements for “Microbiological Examination of Nonsterile Products: “Microbial Enumeration Test”, “Test for Specified Micro-organisms” according to Pharmaceopea The“Growth Promotion Test” requirements for “Microbiological Examination of Nonsterile Products: “Microbial Enumeration Test”, “Test for Specified Micro-organisms” according to PharmaceopeaBasic of strain maintenance - Only the demonstrated “one way” working is acceptable - Stock cultures grown on agar or broth shall be sub-cultured max 3x to get working culture - Working cultures are intended only for one use. It is not allowed to sub-culture them - Working cultures cannot be used as source for new working or stock cultures |