Interpretation and Countermeasure of the Microbiological Examination for Nonsterile Products：Tests for Specified Microorganisms in Chinese Pharmacopoeia (2015 Edition)
- VernacularTitle:《中国药典》2015年版非无菌产品微生物限度检查：控制菌检查法解读与对策
- Author:
Xiaoli YANG
;
Hui LI
;
Yingying MA
;
Jinfang SHENG
;
Changqin HU
- Publication Type:Journal Article
- Keywords:
Microbiological examination;
Tests for specified microorganisms;
Chinese Pharmacopoeia(2015 edition);
Nonsterile products;
Microbial culture system;
Quality control concept
- From:
China Pharmacist
2016;19(4):748-752
- CountryChina
- Language:Chinese
-
Abstract:
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.
