【精品课件】GMP知识培训.ppt

* 人员的管理 人员的资质 工作职责的描述 人员的培训 人员的安全管理 * 仪器设备的管理 仪器设备的采购 以满足检测要求为前提 仪器日志的建立（logbook） 仪器的安装验证及功能测试 方案 报告 仪器的操作方法及人员培训 操作方法SOP 仪器校验或性能测试的SOP 人员的培训及记录 仪器的维护及记录 仪器的周期性验证及再验证 * 文件的管理 文件的种类 SOP，标准操作规程 技术注册文件（质量标准，检验规程） 原始记录及报告 文件的培训及记录 原始数据的管理 实时填写 检查复核批准 存档 超标结果调查 * 试剂和对照品的管理 分类储存 （物料安全数据单MSDS） 固体试剂 液体试剂 易燃易爆、强氧化性、还原性，强酸、强碱及不能混放的 剧毒试剂及易制毒试剂单独管理 室温、低温 普通、干燥器 有效期管理 配制试剂应有配制方法及记录 First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations