In order to analyze the validation results of the total count of mold and yeast in drugs and improve the laborato-ry's ability to detect mold and yeast,this article determined the total count of mold and yeast in two samples in accordance with the NIFDC-PT-446 Capability Validation Operation Guide and the Microbial Counting Method in the Microbial Limit Inspection of Non Sterile Products in Part Four of the 2020 edition of the Chinese Pharmacopoeia.The results show that the |Z| of both samples are less than 2,indicating satisfactory results.This indicates that our laboratory has the ability to de-tect the total count of mold and yeast in drugs.
关键词
药品/霉菌与酵母菌总数计数/能力验证
Key words
Drug/Total Mold and Yeast Count/Proficiency Testing
维普
万方数据