128页新版GSP零售药店质量管理体系文件.doc

锡林浩特市______药店 质量管理体系文件 药店 目录 一、质量管理制度 质量管理体系文件管理制度·································6 质量管理体系文件检查考核制度·····························8 药品采购管理制度·········································10 药品验收管理制度·········································12 药品陈列管理制度·········································14 药品销售管理制度·········································16 供货单位和采购品种审核管理制度···························18 处方药销售管理制度·······································20 药品拆零管理制度·········································21 药品记录和凭证管理制度··································23 收集和查询质量信息管理制度······························24 药品质量事故、质量投诉管理制度··························26 药品有效期管理制度······································28 不合格药品、药品销毁管理制度····························29 环境卫生管理制度········································31 人员健康管理制度········································32 用药咨询、合理用药管理制度······························34 人员培训及考核管理制度··································36 药品不良反应报告规定管理制度····························38 计算机系统管理制度······································40 执行药品电子监管规定管理制度····························42 国家有专门管理要求的药品管理制度························44 二、管理岗位岗位制 1、企业负责人岗位职责·······································46 2、质量管理员岗位职责·······································48 3、药品采购员岗位职责·······································50 4、药品验收员岗位职责·······································52 5、营业员岗位职责···········································53 6、审方药师岗位职责·········································54 7、养护员岗位责任制·········································55 三、操作程序 1、药品采购操作规程·········································56 2、药品验收操作规程·········································60 3、药品销售操作规程·········································63 4、处方审核、调配、审核操作规程·····························66 5、药品拆零销售操作规程·····································67 6、国家有专门管理要求的药品销售操作规程·····················69 7、营业场所药品陈列及检查操作规程···························70 8、营业场所冷藏药品存放操作规程·····························72 9、计算机系统操作和管理操作规程·····························74 四、质量记录表格 1、锡林浩特市××药店质量管理文件审核记录··············