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质量控制实验室第2章：质量控制实验室总体描述.pdfVIP

质量控制实验室第2章：质量控制实验室总体描述.pdf

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    GMP指南1300问

    -

    2023GMP指南

    质量控制实验室第2章

    质量控制实验室总体描述

    李万里

    质量控制实验室第2章：质量控制实验室总体描述

    ●一、法规要求·················································································································································································4

    ●问1：本章主要内容是什么？····················································································································································4

    ●问2：GMP（2010修订）对该章有什么要求？·····················································································································4

    ●二、职责····························································································································································································5

    ●问3：质量控制的最终目的是什么？········································································································································5

    ●问4：质量控制实验室工作主要内容有哪些？························································································································5

    ●问5：实验室布局原则是什么？················································································································································5

    ●问6：质量控制实验室要不要和生产区分开？························································································································5

    ●问7：实验室内部有哪些建议分开？为什么？························································································································5

    ●问8：实验室什么功能间需要有温湿度控制？························································································································5

    ●问9：实验室为什么要单独设置收发室？··················

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