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质量控制实验室第8章：分析方法的验证、确认和转移.pdfVIP

质量控制实验室第8章：分析方法的验证、确认和转移.pdf

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    GMP指南1300问

    -

    2023GMP指南

    质量控制实验室第8章

    分析方法的验证、确认和转移

    李万里

    1/10

    质量控制实验室第8章：分析方法的验证、确认和转移

    ●一、法规介绍··················································································································································································4

    ●问1：本章主要内容有哪些？···················································································································································4

    ●问2：GMP（2010年修）对本章内容有哪些要求？···········································································································4

    ●问3：分析方法验证、转移或确认的目的是什么？···············································································································4

    ●问4：对于分析方法验证、转移或确认除GMP有要求外，还有哪些文件或法规有相应要求？·····································4

    ●二、定义及应用范围···································································································································································4

    ●问5：什么是分析方法？··························································································································································4

    ●问6：分析方法至少应包括什么？···········································································································································4

    ●问7：什么是分析方法验证？···················································································································································4

    ●问8：验证分析项目有哪些？···················································································································································4

    ●问9：验证的性能特征有哪些？·

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