高效液相色谱系统性能验证报告验证方案编号：YB-SB049PQ-01上海和黄药业有限公司ShanghaiHutchisonPharmaceuticalsLimited上海和黄药业有限公司高效液相色谱系统性能验证报告验证报告编号：YB－SB049PQ-00第2页共21页验证方案审批表验证项目名称：高效液相色谱系统性能验证验证项目编号：YB－SB049PQ-00一、方案起草部门职务姓名日期质量检验部主管二、方案审核部门职务姓名日期质量检验部经理工程部经理三、方案批准部门职务姓名日期质量保证部经理上海和黄药业有限公司高效液相色谱系统性能验证报告验证报告编号：YB－SB049PQ-00第3页共21页目录1.验证组织.................................................................................................................................41.1.验证小组人员及职责.........................................................................................................41.1.1.验证小组负责人：.................................................................................................41.1.2.验证小组成员及职责.............................................................................................42.验证目的.................................................................................................................................43.计量器具.................................................................................................................................44.仪器简介.................................................................................................................................55.安装确认.................................................................................................................................56.操作验证.................................................................................................................................86.1.试验项目与限度.................................................................................................................86.2.试验方法.............................................................................................................................86.2.1.流量控制阀.............................................................................................................86.2.2.流动相比例控制阀.................................................................................................86.2.3.进样体积控制阀.....................................................................................................86.2.4.柱温箱检查.............................................................................................................96.2.5.UV检测器波长准确性...........................................................................................97.性能验证.................................................................................................................................98.预防性维修...........................................................................................................................109.附录.......................................................................................................................................10文件检查记录...............................................................................................................................11流量稳定性检查数据...................................................................................................................12流动相比例控制阀检查数据...................
