《中国药典》2015年版微生物限度检查方法适用性中常见问题及分析

The commom problems and analysis of the suitability of microbial limit test in ChP 2015

本文参考近期国内外相关文献,结合本实验室在《中国药典》2015年版非无菌产品微生物限度检查法方法适用性实验中遇到的问题,通过对比10版及15版的异同,调研企业送检常用药品适用性试验数据,对当前方法适用性实验中常见问题予以分析、讨论,并提出有针对性的解决方案并形成综述。为企业提高方法适用性检验技术水平提供帮助。

The recent domestic and foreign related literatures were referred to and the problems encountered by our laboratory in the suitability of the microbial limit test for non-sterile products in the ChP 2015 were considered.The similarities and differences between ChP 2010 and the ChP 2015 were compared,and the suitability test data of commonly used drugs submitted by manufacturer were investigated.The common problems in the suitability test of the current method were analyzed and discussed,and the solutions were proposed accordingly.That provides the help for the manufacturer to improve the suitability test skills.