药品中需氧菌总数计数能力验证结果分析

Analysis of Validation Results of Total Aerobic Bacteria Count Ability in Drugs

目的:通过分析药品中需氧菌总数计数能力验证结果,促进微生物实验室的内部质量控制,提高检验检测技术能力,增强政府监管部门对本实验室能力的信任度。方法: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-340药品中需氧菌总数计数)。结果:样品QA03400502需氧菌总数3.8×10^(4)cfu/mL;样品QA03400327需氧菌总数1.6×10^(3)cfu/mL;样品QA03400657需氧菌总数<10 cfu/mL。3个考核样品│z│值均小于2,且│z│值很小,结果满意。结论:检测实验室具备药品中需氧菌总数检验检测的技术能力,能够保证检测结果的数据准确、可靠。

Objective:To promote the internal quality control of microbiology laboratory,improve the technical ability of inspection and testing,and enhance the trust of government regulatory departments in laboratory ability by analyzing the verification results of the total number of aerobic bacteria in drugs.Methods:According to microbiological limit test of non-sterile products:microbiological counting method in "Chinese Pharmacopoeia" 2020 Part 4 (General Rule 1105) and ability verification operation instruction (total count of aerobic bacteria in NIFDC-PT-340 drugs).Results:The result of sample QA03400502 was 3.8×10^(4) cfu/mL;The results of sample QA03400327 was 1.6×10^(3) cfu/mL.Sample QA03400657 was <10 cfu/mL.After the evaluation,the │z│values of the three samples were all less than 2,and the │z│value was very small,and the results were satisfactory.Conclusion:The laboratory has the technical ability to test the total number of aerobic bacteria in drugs,which can ensure the accurate and reliable data of the test results.