Interpretation and Countermeasure of the Microbiological Examination for Nonsterile Products：Tests for Specified Microorganisms in Chinese Pharmacopoeia (2015 Edition)
Objective:To interpret the main revision of the microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition). Methods:The microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition) was compared with the relevant content in the 2010 edition, and then the differences were investigated. Results:Microbiological examination for nonsterile products:tests for specified microorganisms in Chinese Pharmacopoeia (2015 edition) had been revised at a comparatively large scale in the inspection items, test method, micro-bial culture system, the quality control concept and so on. Conclusion:Microbial inspection system in Chinese Pharmacopoeia (2015 edition) is gradually improved to become a high standard check system in line with the international standards.
Microbiological examinationTests for specified microorganismsChinese Pharmacopoeia(2015 edition)Nonsterile productsMicrobial culture systemQuality control concept
NETL
NSTL
万方数据
维普
