Interpretation and Countermeasure of the Microbiological Examination for Nonsterile Products：Tests for Specified Microorganisms in Chinese Pharmacopoeia (2015 Edition) / 中国药师

ABSTRACT

Objective:To interpret the main revision of the microbiological examination for nonsterile productstests for specified microorganisms in Chinese Pharmacopoeia (2015 edition). Methods:The microbiological examination for nonsterile productstests 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 productstests 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.