An informational-analytical review of alternative microbiological methods for quality testing of pharmaceutical products is presented. The expediency and peculiarities of implementing these methods in pharmacy practice for routine testing are considered. General approaches to validation of new methods are described. The new methods are compared with classical methods in all implementation stages. Foreign regulations on the selection of validation parameters and their acceptance criteria are analyzed.

中文翻译：

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药物质量测试的替代微生物方法及其在药房实践中的实施

信息分析的替代微生物方法对药品的质量测试进行了介绍。考虑了在药房实践中对这些方法进行常规测试的便利性和特殊性。描述了验证新方法的一般方法。在所有实施阶段，将新方法与经典方法进行比较。分析了国外关于验证参数选择及其接受标准的规定。