摘要
目的对药品监督及复核检验过程中获取的部分微生物限度检查方法适用性试验资料进行分析,以期为今后各单位能提供更加完整规范的试验资料,保证微生物限度检查的顺利进行及最终检验结果的准确性提供参考。方法对112份试验资料逐一进行分析,指出问题并参照有关标准进行规范。结果微生物限度检查方法适用性试验资料没有统一的标准,各资料在内容完整性、规范性及严谨性等方面仍存在较多问题,水平差异较大。结论对部分微生物限度检查方法适用性试验资料阐述了包括检品资料信息、试验环境、试验设备以及培养基和菌种等问题,并进行了相应规范。
Objective To provide more complete,standard test data and a reference to ensure the microbial limit test smoothly and the accuracy of final results,the paper analyses some test data of the applicability of microbial limit inspection methods in the course of pharmaceutical supervision and reexamination.Methods An analysis was made on the applicability test data of 112 methods of microbial limit inspection,pointing out the problem and standardizing it with reference to the relevant standards.Results The experimental data still have many problems in terms of content integrity,standardization and rigor with no uniform standard.Conclusion The applicability test data of microbial limit inspection method were pointed out,including inspection information,test environment,test equipment,culture medium and strainand and the specification was carried out.
作者
张红霞
李加恒
ZHANG Hongxia;LI Jiaheng(Microbiology Laboratory of Institute for Drug and Instrument Control of Lanzhou Military Command,Lanzhou Gansu 730050,China)
出处
《中国卫生标准管理》
2018年第8期115-117,共3页
China Health Standard Management
关键词
微生物限度检查
试验资料
规范性
microbial limit inspection
test data
standardization
作者简介
通信作者:张红霞。
