质量控制实验室GMP指南1300问完整版.pdfVIP

质量控制实验室GMP指南1300问完整版.pdf

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G M P 指 南 1 3 0 0 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

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