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药品生产质量管理规范国家食品药品监督管理局目录目录................................................................................................................................................2第一章总则........................................................................................................................................5第二章质量管理................................................................................................................................5第一节原则..............................................................................................................................5第二节质量保证......................................................................................................................5第三节质量控制......................................................................................................................6第四节质量风险管理..............................................................................................................7第三章机构与人员..........................................................................................................................7第一节原则..............................................................................................................................7第二节关键人员......................................................................................................................8第三节培训............................................................................................................................10第四节人员卫生....................................................................................................................10第四章厂房与设施......................................................................................................................11第一节原则............................................................................................................................11第二节生产区........................................................................................................................11第三节仓储区........................................................................................................................12第四节质量控制区................................................................................................................13第五节辅助区........................................................................................................................13第五章设备....................................................................................................................................14第一节原则............................................................................................................................14第二节设计和安装................................................................................................................14第三节维护和维修................................................................................................................14第四节使用、清洁和状态标识............................................................................................14第五节校准............................................................................................................................15第六节制药用水.........................