目录
1.质量管理体系管理制度·············································1 2.质量管理方针和目标管理制度·······································3 3.质量管理体系内审管理制度·········································5 4.质量管理否决权质量制度···········································7 5.质量管理体系文件管理制度·········································9 6.质量信息管理制度················································11 7.供货单位及销售人员资质审核制度··································13 8.购货单位及采购人员资质审核制度··································15 9.药品采购管理制度················································17 10.药品收货管理制度···············································19 11.药品验收管理制度···············································21 12.药品储存与保管管理制度·········································25 13.药品养护管理制度···············································27 14.药品销售管理制度···············································29 15.药品出库复核管理制度···········································31 16.药品运输管理制度···············································33 17.药品有效期管理制度·············································36 18.不合格药品管理制度·············································37 19.不合格药品销毁管理制度·········································39
20.药品退货管理制度···············································40 21.药品召回管理制度···············································42 22.药品质量查询管理制度···········································44 23.药品质量事故管理制度···········································46 24.药品投诉管理制度···············································48 25.药品不良反应报告管理制度·······································50 26.环境卫生和人员健康管理制度·····································52 27.质量方面教育、培训及考核管理制度·······························54 28.设施设备保管和维护管理制度·····································56 29.设施设备验证和校准管理制度·····································57 30.记录和凭证管理制度·············································61 31.计算机系统管理制度·············································63 32.外部质量体系审计管理制度·······································65 33.质量风险评估、控制、审核管理制度·······························66 34.药品储存、运输应急管理制度······································71 35.设施设备应急管理制度···········································74 36.冷藏车检查维护管理制度·········································76 37.质量管理制度执行情况检查与考核制度·····························79 38.计算器具管理制度···············································81 39.药品仓库门禁管理制度···········································82 40.药品直调管理制度···············································84 41.进口药品管理制度···············································85
42.含特殊药品复方制剂管理制度·····································87 43.终止妊娠药品管理制度···········································89 44.生物制品管理制度···············································90 45.中药材（中药饮片）管理制度·····································91 46.蛋白同化剂、肽类激素药品管理制度·······························93 47.客户访问管理制度···············································97 48.药品追溯管理制度···············································98
质量管理体系策划管理制度
文件名称 文件编号 起草人： 质量管理体系策划管理制度 XXXXXX-001-2017 修订审核人： 页数 版本号 批准人： 执行日期： 年 月 日 2 2017—1版 日期： 年 月 日 日期： 年 月 日 修订原因
药品经营许可证变更 一、目的：为确保公司质量管理体系得到有效运行及实施，在建立、实施和执行质量管理体系之前，需要对其进行策划，特制定本制度。
二、依据：《药品管理法》、《药品经营质量管理规范》（国家食品药品监督管理总局令第28号）等法律法规。