Abstract：
In the execution of its legislated responsibilities, the United States Food and Drug Administration commonly refers to standard test methods detailed in the United States Pharmacopeia (USP). Microbiological test methods (contained in general chapters) are listed in chapters <51> to <80> with details regarded as enforceable where referenced as a test method. USP <61> \"Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests\" is a globally harmonized chapter that has been successfully employed for the enumeration of microorganisms recoverable from nonsterile finished drug products. The content of USP <61> is not always scientifically principled nor emphatically understood by all pharmaceutical microbiologists. Consequently, misunderstanding and misapplication of USP <61> may result in analyses and assessments of microbiological quality that are flawed or erroneous. In this article, clarification is provided to assist the pharmaceutical microbiologist in the appropriate and intended use of USP <61>, including provision of details not always commonly known or understood.
摘要：
在履行其法定职责时，美国食品和药物管理局通常参考美国药典（USP）中详述的标准测试方法。微生物测试方法（包含在一般章节中）在章节<51>至<80>中列出，其中作为测试方法引用的细节被认为是可执行的。USP<61>“非无菌产品的微生物学检查：微生物计数测试”是一个全球统一的章节，已成功用于从非无菌成品药品中回收的微生物计数。USP<61>的内容并不总是科学原则，也不是所有的药物微生物学家都强调理解。因此,对USP<61>的误解和误用可能导致微生物质量的分析和评估有缺陷或错误。在这篇文章中,澄清是为了帮助药物微生物学家在USP<61>的适当和预期的用途，包括提供并不总是众所周知或理解的细节。
