江苏明华制药有限公司GFG-60型高效沸腾干燥机验证方案QY·TS·00·003-002012-07-18批准2012-08-18实施江苏明华制药有限公司企业标准验证方案审批表文件名GFG-60型高效沸腾干燥机验证方案文件编号QY·TS·00·003-00内容程序部门签名日期备注起草审核部门负责人签名日期备注生产工程部中心检验室质量保证部批准验证领导小组组长备注:目录1概述...............................................................................................................12验证目的........................................................................................................13验证标准.....................................................................错误!未定义书签。14验证人员........................................................................................................15验证内容........................................................................................................15.1GFG-60型高效沸腾干燥机URS.........................................................15.2预确认(设计确认)..........................................................................35.2.1预确认目的...............................................................................35.2.2预确认内容...............................................................................35.3安装确认...........................................................................................45.3.1安装确认目的............................................................................45.3.2安装确认内容...........................................................................45.4运行确认.............................................................................................65.4.1运行确认目的............................................................................65.4.2运行确认内容...........................................................................75.5性能确认...........................................................................................85.5.1性能确认内容............................................................................85.5.2干燥机性能检查记录................................................................95.6GFG-60型高效沸腾干燥机验证综合评价表....................................106.最终评价和批准......................................................