类别:工艺验证方案编号:YZ-PVP-014-00部门:注射剂车间方案页码:共22页工艺验证方案品名:维生素B1注射液规格:2ml:0.1g批量:300L版次:新订替代:方案起草人:日期:年月日验证小组长:日期:年月日方案批准人:日期:年月日验证领导小组部门(岗位)签名日期年月日年月日年月日年月日年月日验证小组成员年月日年月日年月日年月日年月日年月日年月日目录1.概述......................................................................................................................................................11.1背景介绍............................................................................................................................................11.2验证条件............................................................................................................................................11.3验证程序............................................................................................................................................11.4工艺流程图........................................................................................................................................11.5工艺过程概述....................................................................................................................................12.目的......................................................................................................................................................13.范围......................................................................................................................................................14.职责......................................................................................................................................................14.1验证领导小组....................................................................................................................................14.2注射剂车间........................................................................................................................................14.3质量保证部........................................................................................................................................14.4质量控制部........................................................................................................................................15.依据......................................................................................................................................................16.验证前确认..........................................................................................................................................16.1公用系统、关键设备的确认.............................................................................................................16.2仪器、仪表、衡器校验完成确认.....................................................................................................16.3相关检验条件完成确认.....................................................................................................................16.4公用介质的确认................................................................................................................................16.5文件资料确认....................................................................................................................................1...