行业插件 V12.5 操作手册 1 / 56 GSP 管理行业插件产品 U8+V12.5操作手册行业插件 V12.5 操作手册 2 / 56 目录一.应用场景...................................................................61.1 产品范围............................................................. .61.2 业务背景............................................................. .61.3 采购入库验收业务流程..................................................71.4 销售退货验收业务流程..................................................81.5 抽检业务..............................................................91.6 不合格品管理..........................................................91.7 在库品养护、复检管理.................................................10二. 操作说明.................................................................122.1 设置.................................................................122.1.1 选项................................................................................................................... .122.1.2 行业模板初始化.................................................................................................132.1.3 分类体系........................................................................................................... .142.1.4 GSP 管理制度分类.............................................................................................142.1.4.1 GSP 标准分类.........................................................................................142.1.4.2 GSP 设施类型设置.................................................................................152.1.5 基础档案........................................................................................................... .162.1.5.1 GSP 管理制度档案.................................................................................162.1.5.2 GSP 标准档案.........................................................................................162.1.5.3 GSP 设施档案.........................................................................................162.2 首营管理.............................................................162.2.1 首营企业审批表.................................................................................................162.2.2 首营客户审批表.................................................................................................172.2.3 首营品种审批表.................................................................................................182.2.4 合格供货方档案表.............................................................................................192.3 采购入库质量验收.....................................................192.3.1 药品采购入库质量验收记录单.........................................................................192.3.2 进口药品采购入库质量验收记录单.................................................................202.3.3 中药材、饮片采购入库质量验收记录单.........................................................212.3.4 特殊药品采购入库质量验收记录单.................................................................212.3.5 医疗器械质量验收记录单.................................................................................212.3.6 化学制剂采购入库质量验收记录单.................................................................212.3.7 玻璃仪器采购入库质量验收记录单.................................................................222.3.8 注射剂采购入库可见异物检查记录单.............................................................222.4 销售退货入库质量验收.................................................222.5 销售出库质量复核.....................................................232.6 采购退货出库质量复核.................................................242.7 直调药品验收记录.....................................................252.8 在库品养护、复检管理.................................................26行业插件 V12.5 操作手册 3 / 56 2.8.1 药品养护档案.....................................................................................................262.8.2 重点养护药品确认表.........................................................................................272.8.3 养护计划查询.....................................................................................................282.8.4 在库品质量养护检查记录单.............................................................................292.8.5 在库品质量复检通知单.....................................................................................292.8.6 在库品质量复检记录单.....................................................................................302.8.7 药品养护质量问题摘要.....................................................................................302.8.8 中药标本管理记录单.........................................................................................312.8.9 中药饮片分装记录.............................................................................................312.8.10 破损药品登记册...............................................................................................312.8.11 重点养护品种确认汇总表...............................................................................312.9 药品停售及恢复销售管理...............................................322.9.1 药品停售通知单.................................................................................................322.9.2 药品恢复销售通知单.........................................................................................332.10 药品运输及温湿度记录................................................332.10.1 药品运输记录...................................................................................................332.10.2 库房温湿度记录单...........................................................................................342.10.3 库外温湿度记录单...........................................................................................342.11 不合格品管理........................................................352.11.1 药品拒收报告单...............................................................................................352.11.2 不合格品处理审批表.......................................................................................362.11.3 不合格品报损审批表.......................................................................................362.11.4 报损药品销毁通知单.......................................................................................372.11.5 不合格药品销毁结果存根...............................................................................372.12 检验业务............................................................372.12.1 检品抽（送）验单...........................................................................................372.12.2 药品检验报告书...............................................................................................382.12.3 医疗器械检测报告书.......................................................................................392.12.4 玻璃仪器检测报告书.......................................................................................392.12.5 化学试剂检测报告书.......................................................................................392.12.6 化学室检品登记表...........................................................................................402.12.7 滴定液配制及标定记录单...............................................................................402.12.8 药品崩解时限测定记录单...............................................................................402.13 药品质量信息管理....................................................402.13.1 药品质量档案...................................................................................................402.13.2 药品质量信息反馈单.......................................................................................412.13.3 药品不良反应报告...........................................................................................412.13.4 药品质量查询登记表.......................................................................................422.13.5 药品质量查询处理结果记录单.......................................................................422.13.6 验收异常质量状况记录单...............................................................................422.13.7 有质量问题典型品种事例...............................................................................432.13.8 质量事故分析报告书.......................................................................................432.13.9 药品质量信息季度汇总报表...........................................................................432.14 其他业务............................................................43行业插件 V12.5 操作手册 4 / 56 2.14.1 售后服务管理...................................................................................................432.14.1.1 商品质量、质量管理征询意见书.......................................................442.14.1.2 商品质量、价格、销售服务征询意见书...........................................442.14.1.3 顾客投诉受理卡...................................................................................442.14.2 设施管理......................................................................................................... .452.14.2.1 设施使用记录单.................................................................................452.14.2.2 天平及精密仪器使用记录单...............................................................452.14.2.3 设施检查记录单...................................................................................462.14.2.4 设施维修记录单...................................................................................462.14.2.5 设施保养记录单...................................................................................462.14.2.6 设施报废审批表...................................................................................462.14.2.7 强制检定计量器具检定记录卡...........................................................472.14.2.8 非强制检定计量器具检定记录卡.......................................................472.14.3 人员与培训管理...............................................................................................472.14.3.1 个人健康检查档案表...........................................................................472.14.3.2 年职员教育培训计划...........................................................................472.14.4 GSP 质量管理工作表.......................................................................................482.14.4.1 年目标规划...........................................................................................482.14.4.2 年经营指导思想和经营方针...............................................................482.14.4.3 年重点工作目标...................................................................................482.14.4.4 年方针目标展开图...............................................................................482.14.4.5 方针目标实施情况评价汇总表...........................................................492.14.4.6 经营目标责任制检查表.......................................................................492.14.4.7 GSP 管理内部评审记录.......................................................................492.14.4.8 季度质量方针目标考核表...................................................................492.14.4.9 纠正和预防措施通知书.......................................................................502.14.4.10 信息传递反馈单.................................................................................502.15 购进销售记录查询....................................................502.15.1 采购记录查询...................................................................................................502.15.2 采购退货记录查询...........................................................................................512.15.3 销售记录查询...................................................................................................512.15.4 销售退货记录查询...........................................................................................512.16 停售药品记录查询....................................................512.17 报表................................................................52行业插件 V12.5 操作手册 5 / 56 2.17.1 存货批次业务追溯...........................................................................................522.17.2 预警查询......................................................................................................... .522.17.2.1 近效期药品催销预警...........................................................................522.17.2.2 在库品周期养护预警...........................................................................532.17.2.3 药品运输到达预警...............................................................................532.17.3 质量管理台帐...................................................................................................542.17.3.1 销售出库质量复核台帐.......................................................................542.17.3.2 采购退货出库质量复核台帐...............................................................542.17.3.3 质...
