《中国药典》微生物鉴定相关标准体系建立的回顾及展望

微生物污染在制剂、原辅料以及生产环境中具有分布不均匀、控制难度大等特点,控制不得当会严重影响着产品质量和用药安全。微生物鉴定在微生物的检验和控制工作中尤为重要,只有对微生物进行了适宜的鉴定,才能满足药品质量控制、偏差调查和溯源分析的需要,进而实现对药品的全生命周期质量控制。本综述全面回顾了《中国药典》收载的与微生物鉴定相关标准内容和检验方法,对比国外药典微生物鉴定相关部分标准要求,同时对《中国药典》微生物鉴定相关未来发展方向进行了展望,旨在为药品相关微生物检验工作提供信息,同时也为今后药典增修订相关通则及指导原则提供借鉴和参考。

Review and prospect of establishment of relevant standard system for microbial identification in Chinese Pharmacopoeia

Microbial contamination is frequent and difficult to control in the preparation, raw materials and production environment, and improper control will seriously affect product quality and drug safety. Microbial identification is particularly important in the inspection and control of microorganisms. Only by accurate identification of microorganisms can we meet the needs of drug quality control, deviation investigation and traceability analysis, so as to achieve the quality control of the whole life cycle of drugs. This review comprehensively reviewed the content and test methods of microbiological identification standards contained in Chinese Pharmacopoeia, compared the requirements of some standards related to microbiological identification in foreign pharmacopoeia, and looked forward to the future development direction related to microbiological identification in Chinese Pharmacopoeia, aiming to provide information for the work of drug-related microbiological testing. At the same time, it also provides reference for the future revision of pharmacopoeia related general rules and guiding principles.