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GMP指南1300问

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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最新进展或实践?····································································································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

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