An informational and analytical review regarding microbiological monitoring in the analysis of pharmaceutical product quality is presented. Regulated types of microbiological monitoring are considered. General approaches to conducting environmental monitoring and their possible advantages and disadvantages are analyzed. Domestic and foreign regulations on monitoring rules are studied. Factors having a key effect on environmental monitoring results in the analysis of pharmaceutical product quality are identified.

中文翻译：

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药品质量分析中的微生物监测

提出了有关药品质量分析中微生物监测的信息和分析综述。考虑了受监管的微生物监测类型。分析了进行环境监测的一般方法及其可能的优点和缺点。研究了国内外监管规则的规定。确定了对药品质量分析中的环境监测结果具有关键影响的因素。