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质量控制实验室第1章：概述.pdf

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GMP指南1300问

2023GMP指南

质量控制实验室第1章

概述

李万里

质量控制实验室第1章：概述

●一、目的····························································································································································································3

●问1：为什么要建立实验室管理体系？····································································································································3

●问2：本指南制定的基础是什么？············································································································································3

●问3：本指南参考了哪些机构或组织的必威体育精装版进展或实践？····································································································3

●二、范围····························································································································································································3

●问4：质量控制实验室管理适用于产品生命周期的哪些环节？····························································································3

●问5：产品技术转移着重点是什么？········································································································································3

●问6：产品技术转移一般涵盖什么环节？································································································································3

●问7：商业化生产的着重点是什么？········································································································································3

●问8：产品贮存/运输着重点是什么？·······································································································································3