药品中需氧菌总数计数能力验证方法分析  

Analysis on the Verification Method of Total Counting Ability of Aerobe in Drugs

作　　者：王家芳 WANG Jia-fang(Linyi Inspection and Testing Center,Linyi 276000,China)

机构地区：[1]临沂市检验检测中心,山东临沂276000

出　　处：《药物生物技术》2024年第1期59-61,共3页Pharmaceutical Biotechnology

摘　　要：药品检验机构的检测能力是药品质量安全的重要技术支撑,药品检验机构通过持续参加能力验证活动,可以对实验室进行质量控制,了解实验室检测能力及质量管理水平,提高实验室的检验水平,发现自身在检验过程中的不足和问题,促进实验室质量管理能力的提升,增强政府监管部门对本实验室能力的信任度。此次能力验证活动,收到上海市食品药品检定研究院提供的样品3份,编号分别为:QA03400153,QA03400333,QA03400440。根据《NIFDC-PT-340药品中需氧菌总数计数能力验证作业指导书》及《中国药典》2020年版四部1105非无菌产品微生物限度检查法:平皿法,进行需氧菌总数计数。结果:3份样品结果分别为:QA03400153:2.5×10^(4)CFU/mL;QA03400333:小于1 CFU/mL;QA03400440:3.3×10^(4)CFU/mL。本次能力验证获得中国食品药品检定研究院给出的满意结果,其中样品QA03400440的Z值比分数为-0.21;样品QA03400153的Z值比分数为-0.50。证明实验室质量管理体系运行有效,具备承担食药品等监督检验及日常监测检验任务的能力。通过参加能力验证活动可以提升检验者的操作水平,提高实验室的质量管理水平,促进实验室管理体系的完善。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:QA03400153:2.5×10^(4) CFU/mL;QA03400333:less than 1 CFU/mL;QA03400440:3.3×10^(4) 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.

关 键 词：药品 微生物限度 需氧菌计数 能力验证 质量管理 人员操作 

分 类 号：R927.1[医药卫生—药学]