生产过程分析技术中所提倡使用的快速微生物检查法的作用  

The Role of Rapid Microbiological Methods within the Process Analytical Technology Initiative

作　　者：许华玉[1] 张志芬[1] 王平[1] 

机构地区：[1]国家药典委员会,北京100050

出　　处：《中国药品标准》2005年第3期79-82,共4页Drug Standards of China

摘　　要：本篇文章讨论了FDA在其倡议的生产过程分析技术(PAT)中,采用快速微生物检查法对中间产品和成品进行质量监控的作用。文章中指出了依靠微生物生长而导致培养时间较长的检查法的缺点。作者在文中简要阐述了几种候选的快速微生物检查法。作为风险评估的手段,作者提出了生产中哪些关键的微生物检验环节可采用快速微生物检查法。This article discusses the role of rapid microbiological methods for in-process and finished-product testing with in the context of the FDA Process Analytical Technology Initiative. The disadvantage of the extended incubation time required by growth-based microbiological methods is emphasized in this stimuli article. The authors briefly review candidate technologies for rapid microbiological testing. Using risk assessment tools, the authors identify critical microbial tests where these rapid microbiological methods could be applied.

关 键 词：生产过程分析技术 快速微生物检查法 PAT 微生物试验 细胞分裂 

分 类 号：R915[医药卫生—微生物与生化药学]