Analysis of verification results of detection ability of molds and yeasts in drug
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 6.6×104 CFU/g;The total number of mold and yeast in sample 0673 was 6.5×104 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.
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