药品微生物经典分析方法的验证探讨

本文通过研读分析药品、食品和环境微生物分析方法验证的相关规范性文件，结合药品微生物分析实践，对药品微生物经典分析方法的验证进行了研究，总结了微生物分析方法验证的考察指标，包括专属性、灵敏度、精密度、检测限和定量限、线性、范围、耐用性及方法适用性等，并阐述了各指标在药品微生物分析中的含义、测量方法、影响因素和可接受标准。为规范经典微生物分析方法的验证，获得可靠的微生物检验结果及建立相关指导原则，提供了参考依据。

Medicine conventional microbiological method validation

Based on the interpretation and analysis of the standard documents on medical, food, and environmental microbiological method validation, combining with the practical experience of medicine microbiological analysis, this study focused on the medicine conventional microbiological method validation. Herein, we summarized the critical characteristics in the medicine conventional microbiological method validation, including specificity, sensitivity, precision, limit of detection, limit of quantification, linearity and range, robustness, and suitability. The definitions, measurements, affecting factors, and acceptable standards of the characteristics were elaborated. This study provided a reference for standardizing conventional microbiological method validation, obtaining reliable analytical results, and establishing the relative guiding principle.