Analysis on the Verification Method of Total Counting Ability of Aerobe in Drugs
The testing ability of drug testing institutions is an important technical support for drug quality and safety.Through continuous participation in capacity verification activities,drug testing institutions can carry out quality control of laboratories,understand laboratory testing ability and quality management level,improve laboratory testing level,find shortcomings and problems in the testing process,and promote the improvement of laboratory quality management ability,enhance the trust of the government regulatory authorities in the competence of the laboratory.In this capability verification activity,3 samples provided by Shanghai Institute of Food and Drug Control were received,QA03400153,QA03400333 and QA03400440 were numbered respectively.The total number of aerobic bacteria was counted according to the"NIFDC-PT-340 Drug Total counting ability Verification Operation Instruction"and the"Chinese Pharmacopoeia"2020 edition of the fourth part 1105 non-sterile product microbial limit test method:plate method.The results of 3 samples were:QA03400153:2.5 × 104 CFU/mL;QA03400333:less than 1 CFU/mL;QA03400440:3.3 ×104 CFU/mL.Satisfactory results were obtained from China National Institute of Food and Drug Control,and the Z-score of sample QA03400440 was-0.21.The Z score of the sample QA03400153 was-0.50,which proves that the laboratory quality management system is running effectively,and it has the ability to undertake food and drug supervision and daily monitoring and inspection tasks.By participating in the ability verification activities,the operation level of inspectors can be improved,the quality management level of the laboratory can be improved,and the perfection of the laboratory management system can be promoted.
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