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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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