药品微生物限度检验结果的相关影响要素分析

Analysis of Relevant Influencing Factors of Drug Microbial Limit Test Results

本文以云南省怒江州食品药品检验所2018年12月—2019年12月接受药品微生物限度检验的临床药品为研究对象,统计分析药品微生物限度检查差异的影响因素,并结合各地药检中心相关资料进行对比分析。结果显示,共发生44例微生物限度检查误差,发生率5.24%。其中,影响因素占比从高到低分别是检验人员的质量控制意识、操作技能水平、活体易变性、抑菌成分、操作技术标准、质量控制标准、实验室环境质量控制标准、培养基质量,总占比0.55以上,与其他机构药品微生物检验结果误差基本一致。

This paper accepted batches of clinical medicines in Nujiang Prefecture Food and Drug Inspection Institute of Yunnan Province from December 2018 to December 2019 as the research object,statistically analyzed for the influencing factors of the differences in the pharmaceutical microorganism limit inspection,and combined with relevant data from local drug inspection centers comparative analysis.The results show that a total of 44 microbial limit check errors occurred,with an incidence rate of 5.24%.Among them,the proportion of influencing factors from high to low is the inspector's quality control awareness,operating skill level,living variability,bacteriostatic ingredients,operating technical standards,quality control standards,laboratory environmental quality control standards,culture medium quality,and total.It accounts for more than 0.55,which is basically consistent with the error of the results of microbiological testing of drugs by other institutions.