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质量控制实验室第12章：微生物实验室质量管理和检验.pdf

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GMP指南1300问

2023GMP指南

质量控制实验室第12章

微生物实验室质量管理和检验

李万里

InformationClassification:General

质量控制实验室第12章：微生物实验室质量管理和检验

●一、法规介绍································································································································································12

●问1：本章主要内容有哪些？·································································································································12

●问2：GMP（2010修）有哪些要求？·················································································································12

●问3：除GMP外还有哪些文件对该方面有相关要求？······················································································12

●问4：《中国药典》中表述，影响药品微生物检验结果的因素有哪些？····························································12

●问5：微生物实验室质量管理内容包括哪些？·····································································································12

●问6：不属于微生物检验范围，但是按照微生物实验室管理的有哪些？··························································13

●二、人员资质及培训要求·······································································································································13

●问7：如果微生物是一个独立机构应怎样设置岗位？是否可以一人多岗？······················································13

●问8：对于人员的资质和培训要求可以参考哪些要求？·····················································································13

●问9：微生物操作培训可分为哪些岗位？·············································································································13

●问10：基础岗培训的理论知识有哪些？···············································································································13

●问11：微生物实验室基础操作包括哪些内容？················

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