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...
