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GMP指南1300问
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2023GMP指南
质量控制实验室第5章
试剂、试验用溶液、试验用水与耗材的管理
李万里
质量控制实验室第5章：试剂、试验用溶液、试验用水与耗材的管理
●一、法规介绍············································································································································4
●问1：该章主要讲述了哪些内容？···········································································································4
●问2：有哪些法规要求？···························································································································4
●问3：GMP对试剂、试液等的规定提到了哪些操作和记录？·····························································4
●二、背景介绍···········································································································································4
●问4：为什么要对试剂、试验用溶液、试验用水与耗材进行有效管理？············································4
●问5：如何选用试剂？····································································································································4
●问6：试验用水是什么水？···························································································································4
●问7：试验耗材指哪些？································································································································4
●问8：本章包含滴定液和培养基的管理吗？······························································································4
●三、试剂的采购、验收·························································································································4
●问9：试剂供应商档案包括哪些内容？······································································································4
●问10：要不要对供应商进行评估和审计？································································································5
●问11：是不是所有的试剂都要进行质量验收？···························································
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