药品中霉菌和酵母菌计数能力验证结果分析

Analysis of verification results of detection ability of molds and yeasts in drug

为提升药品中霉菌和酵母菌总数检验能力,促进实验室内部质量控制,本实验室参加了中国食品药品检定研究院组织的NIFDC-PT-446药品中霉菌和酵母菌总数计数能力验证。依据《中国药典》2020年版四部通则1105非无菌产品微生物限度检查:微生物计数法和能力验证作业指导书(NIFDC-PT-446药品中霉菌和酵母菌总数计数)。结果显示,样品0667霉菌和酵母菌总数为6.6×10^(4)CFU/g,样品0673霉菌和酵母菌总数为6.5×10^(4)CFU/g,经评价,2个考核样品的|Z|值均小于2,结果满意。实验室具备药品中霉菌和酵母菌计数检测能力。

To strengthen the detection capability of molds and yeasts in drug and promote the internal quality control of microbiology.The laboratory participated in proficiency testing on mould and yeast detection in drugs of NIFDC-PT-446 organized by National Institutes for Food and Drug Control.According to the four general rules of the Chinese Pharmacopoeia 2020 edition 1105 microbial limit inspection of non-sterile products:microbial counting method and the guidance on the tesing ability verification of mold and yeast count in drug(NIFDC-PT-446).The results showed that the total number of mould and yeast in sample 0667 was 6.6×10^(4) CFU/g;The total number of mold and yeast in sample 0673 was 6.5×10^(4) CFU/g.According to the evaluation,the|Z|values of the 2 assessment samples were all less than 2.0,and the evaluation results were satisfactory.The laboratory has the ability to detect the count of mold and yeast in drugs.