药品微生物限度检验误差影响因素分析

摘要

目的：分析药品微生物限度检验误差影响因素，为今后改进工作提出科学建议。方法：分析我单位药品微生物限度检验误差资料，结合各地药检中心相关资料，对比综合分析。结果：供试液的制备引起的误差在统计数据中构成比最高，环境及检验设备构成比较高。结论：微生物检验误差中，供试液制备、环境因素所占比例较大，应减少操作误差，提高环境质量和检验设备的水平。%Objective: Make an analysis on error factors of drug microbial limit test to give scientific advices for relative works. Method:Make an analysis on data of our unit on error factors of drug microbial limit test, combined with the study of relevant information in other Centers for drug control, make a comprehensive study. Result: Error of test solution preparation has the highest part in the statistics. Environmental and inspection equipment also be the important parts. Conclusion:Among error factors of microbial limit test, test solution has the greatest impact on result. Equipment and the environment also have great impacts. Errors caused by manual operation should be minimized. We should improve the level of environment and inspection equipment.