药品微生物检验替代方法国内外研究进展

快速微生物检测技术可提高检测效率和自动化程度，并为药品微生物检验的数据可靠性提供新思路，同时部分技术能够利用其即时监控的特点改进药品生产过程控制方式。各国药典及相关组织很早就开始研究和规范药品微生物检验替代方法验证的内容，并且不断地完善。本文总结了快速微生物检测技术作为药品微生物检验替代方法的技术原理和近些年的研究应用进展，并介绍了国内外相关法规指南的变化。

Rapid microbiological methods are able to enhance detection efficiency and automation,and provide new ideas for data integrity during drug microbiological examination. At the same time,some of them are expected to improve the control mode of drug manufacturing based on their characteristics of real-time monitoring. The pharmacopoeias in various countries and relevant organizations had already studied and standardized the contents of validation for alternative microbiological methods in pharmaceutical industry for long time,and have been constantly improving. The principle of rapid microbiological method as an alternative method for pharmaceutical microbial testing and its application progress in recent years is reviewed in this paper,and the changes of relevant global regulations and guidelines are also introduced.

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