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GMP指南1300问
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2023GMP指南
质量控制实验室第7章
实验室设备和分析仪器的管理
李万里
1/8
质量控制实验室第7章：实验室设备和分析仪器的管理
●一、法规介绍··················································································································································································4
●问1：本章主要讲了哪些内容？···············································································································································4
●问2：GMP（2010修订）对本章内容有哪些要求？···········································································································4
●问3：除了GMP对本章内容有要求外，还有哪些文件对本章有相关要求？····································································4
●问4：实验室设备和仪器是否需要提供URS？有哪些作用？······························································································4
●问5：URS应涵盖哪些内容？以怎样形式收集？··················································································································4
●问6：URS文件应包含哪些内容？··········································································································································4
●问7：URS文件中的用户需求内容一般包括哪些内容？······································································································4
●二、仪器确认··················································································································································································4
●问8：实验室仪器设备分类可以分为哪些级别？···················································································································4
●问9：哪些可以划分为A类？······························································
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