CNAS T0781药品的无菌检查(薄膜过滤法)能力验证结果与分析  

Proficiency Testing Results and Analysis in CNAS T0781 the Sterility Test (Membrane Filtration Method) of Drug

作　　者：江志杰[1] 张光华[1] 刘文杰[1] 高春[1] JIANG Zhijie;ZHANG Guanghua;LIU Wenjie;GAO Chun(Beijing Institute for Drug Control,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室,102206

出　　处：《首都食品与医药》2018年第16期104-105,共2页Capital Food Medicine

摘　　要：目的考核实验室检查药品无菌的能力。方法按CNAS RL02-2010、CNAS GL03-2006等要求,设计和实施了"CNAS T0781药品的无菌检查(薄膜过滤法)能力验证计划",包括方案设计、样品制备、均匀性和稳定性检验、结果分析等。结果共有84家实验室参与并报送了实验结果,满意实验室有76家,达到90%以上,并对问题和不满意结果进行技术分析。结论本次能力验证为整体提升我国药品无菌检查能力具有重要意义。Objective The test was to assess the laboratory capacity of sterility test of drug. Methods Some standards were used including CNAS RL02-2010 and CNAS GL03-2006,the CNAS T0781, Proficiency testing program for the sterility test（membrane filtration method） of drug, was designed and implemented,including program design, sample preparation, uniformity and stability test, the results of analysis, etc, Results A total of 84 laboratories participated and submitted to the experimental resuhs.76 laboratory results were satisfactory,reached more than 90%,and technical analysis was carried out about the problems and the dissatisfied results.Conc I us i on Through the accreditation program,this program is helpful to upgrade the technical capability of the sterility test of drug in China and to evaluate the detection level for the participants.

关 键 词：无菌检查 薄膜过滤法 能力验证 

分 类 号：R95[医药卫生—药学]