中药饮片生产企业GMP总目录.doc

药品生产许可证申报资料十四拟办企业生产管理、质量管理文件目录甘肃弘润药业有限公司一、管理标准文件序号编号文件名称1HR-SMP-01-001-00质量诚信管理规程2HR-SMP-01-002-00组织机构管理规程3HR-SMP-01-003-00员工培训管理规程4HR-SMP-01-004-00授权管理规程5HR-SMP-01-005-00员工接触危险物质预防管理规程6HR-SMP-01-006-00操作人员上岗、调岗培训管理规程7HR-SMP-01-007-00培训档案管理规程8HR-SMP-01-008-00健康检查管理规程9HR-SMP-01-009-00员工守则10HR-SMP-01-010-00员工请假管理制度11HR-SMP-01-011-00防火、防爆、防毒管理规程12HR-SMP-01-012-00接待工作管理制度13HR-SMP-01-013-00车辆管理制度14HR-SMP-01-014-00办公设施、设备、用品管理制度15HR-SMP-01-015-00劳动保护用品管理制度16HR-SMP-01-016-00厂区环境及卫生管理制度17HR-SMP-01-017-00厂区绿化管理制度18HR-SMP-01-018-00厂区废弃物处理规程19HR-SMP-01-019-00卫生间清洁管理制度20HR-SMP-01-020-00关键岗位人员管理规程21HR-SMP-01-021-00质量受权人管理规程22HR-SMP-02-001-00标准文件管理规程23HR-SMP-02-002-00原始记录管理规程24HR-SMP-02-101-00GMP自检管理规程25HR-SMP-02-102-00质量否决权管理制度26HR-SMP-02-103-00产品质量档案管理规程27HR-SMP-02-104-00质量例会及月报制度28HR-SMP-02-105-00产品质量台帐管理制度29HR-SMP-02-106-00质量事故管理制度30HR-SMP-02-107-00质量方针目标管理规程31HR-SMP-02-108-00信息沟通管理规程32HR-SMP-02-109-00质量风险管理(QRM)规程33HR-SMP-02-110-00变更管理规程34HR-SMP-02-111-00生产过程质量监控管理规程35HR-SMP-02-112-00生产用水质量监控管理规程36HR-SMP-02-113-00稳定性考察管理规程37HR-SMP-02-114-00纠正和预防措施系统管理规程38HR-SMP-02-115-00产品质量回顾分析管理规程39HR-SMP-02-201-00不合格品管理规程40HR-SMP-02-202-00不合格品销毁管理规程41HR-SMP-02-203-00留样观察管理规程42HR-SMP-02-204-00原始记录管理规程43HR-SMP-02-205-00色标管理规程44HR-SMP-02-206-00取样管理规程45HR-SMP-02-207-00留样管理规程46HR-SMP-02-208-00成品审核放行管理规程47HR-SMP-02-301-00用户访问管理规程48HR-SMP-02-302-00用户投诉处理规程49HR-SMP-02-303-00产品召回管理规程50HR-SMP-02-304-00退回产品处理规程51HR-SMP-02-305-00药品不良反应报告和监测管理规程52HR-SMP-02-306-00药品信息报告管理规程53HR-SMP-02-401-00检验管理规程54HR-SMP-02-402-00实验室安全操作管理规程55HR-SMP-02-403-00实验室防火管理规程56HR-SMP-02-404-00实验室危险物品管理规程57HR-SMP-02-405-00实验室废弃物处理规程58HR-SMP-02-406-00检测仪器设备管理规程59HR-SMP-02-407-00检测仪器、设备维修保养管理规程60HR-SMP-02-408-00化学试剂配制管理规程61HR-SMP-02-409-00化学试剂贮存管理规程62HR-SMP-02-410-00实验室特殊试剂管理规程63HR-SMP-02-411-00标准品、对照品管理规程64HR-SMP-02-412-00滴定液、标准溶液管理规程65HR-SMP-02-413-00容量玻璃器具校准管理规程66HR-SMP-02-414-00成品稳定性试验管理规程67HR-SMP-02-415-00检验偏差处理规程68HR-SMP-02-416-00有效数字修约及运算规程69HR-SMP-02-417-00委托检验管理规程70HR-SMP-02-418-00检验报告管理规程71HR-SMP-03-001-00生产文件管理规程72HR-SMP-03-002-00批号编制管理规程73HR-SMP-03-003-00生产计划管理规程74HR-SMP-03-004-00安全生产管理制度75HR-SMP-03-005-00生产事故管理制度76HR-SMP-03-006-00生产试验管理规程77HR-SMP-03-007-00生产过程管理规程78HR-SMP-03-008-00生产过程偏差处理规程79HR-SMP-03-009-00生产技术分析管理规程80HR-SMP-03-010-00生产用水管理规程81HR-SMP-03-011-00车间交接班管理制度82HR-SMP-03-012-00生产指令管理规程83HR-SMP-03-013-00批生产记录管理规程84HR-SMP-03-014-00委托生产管理规程85HR-SMP-03-015-00返工管理规程86HR-SMP-03-016-00重新加工管理规程87HR-SMP-03-101-00物料平衡管理规程88HR-SMP-03-102-00计算与称量核对管理规程89HR-SMP-03-103-00清场管理规程90HR-SMP-03-104-00生产定置管理规程91HR-SMP-03-105-00中间站管理规程92HR-SMP-03-106-00物料交接管理规程93HR-SMP-03-107-00产品零头管理规程94HR-SMP-03-108-00生产过程标签管理规程95HR-SMP-03-110-00贵细药材管理制度96HR-SMP-03-111-00物料使用管理规程97HR-SMP-03-112-00生产批号及生产日期管理规程98HR-SMP-03-201-00生产车间新进人员培训管理规程99HR-SMP-03-202-00生产人员出入车间管理规程100HR-SMP-03-203-00非生产人员进出车间管理规程101HR-SMP-03-204-00一般生产区卫生管理规程102HR-SMP-03-205-00清洁剂、消毒剂管理规程103HR-SMP-03-206-00工作服管理规程104HR-SMP-03-207-00周转容器管理规程105HR-SMP-03-208-00清洁工具管理规程106HR-SMP-03-209-00设备清洁管理规程107HR-SMP-03-301-00厂房设施管理规程108HR-SMP-03-302-00厂区环境保护管理规程109HR-SMP-03-303-00厂房防鼠、防虫管理规程110HR-SMP-03-304-00配电室安全管理规程111HR-SMP-03-401-00设备供应商选择管理规程112HR-SMP-03-402-00设备选型选购管理规程113HR-SMP-03-403-00设备订货合同管理规程114HR-SMP-03-404-00设备开箱验收管理规程115HR-SMP-03-405-00设备安装调试验收规程116HR-SMP-03-406-00设备编号管理规程117HR-SMP-03-407-00设备巡回检查管理规程118HR-SMP-03-408-00设备备件管理规程119HR-SMP-03-409-00设备档案管理规程120HR-SMP-03-410-00设备使用管理规程121HR-SMP-03-411-00设备状态标志牌管理规程122HR-SMP-03-412-00设备维修安全管理规程123HR-SMP-03-413-00设备保养检修管理规程124HR-SMP-03-414-00设备委托维修、备件加工管理规程125HR-SMP-03-415-00设备故障处理规程126HR-SMP-03-416-00设备事故管理规程127HR-SMP-03-417-00设备封存、启用及调拨管理规程128HR-SMP-03-418-00设备报废管理规程129HR-SMP-03-419-00设备润滑管理规程130HR-SMP-03-420-00维修工具管理规程131HR-SMP-03-501-00计量器具管理规程132HR-SMP-03-502-00计量器具配置管理规程133HR-SMP-03-503-00计量器具订购、验收及贮存管理规程134HR-SMP-03-504-00精密仪器使用管理规程135HR-SMP-03-505-00不合格计量器具管理规程136HR-SMP-03-601-00验证管理规程137HR-SMP-03-602-00厂房设施确认管理规程138HR-SMP-03-603-00设备确认管理规程139HR-SMP-03-604-00工艺验证管理规程140HR-SMP-03-605-00检验方法验证管理规程141HR-SMP-03-606-00清洁验证管理规程142HR-SMP-04-001-00物料购入管理规程143HR-SMP-04-002-00物料购销合同管理规程144HR-SMP-04-003-00物料供应商审核管理规程145HR-SMP-04-004-00仓库盘存管理规程146HR-SMP-04-005-00危险品物料仓储管理规程147HR-SMP-04-006-00仓库安全管理制度148HR-SMP-04-007-00仓库卫生管理制度149HR-SMP-04-008-00仓储帐、卡、记录管理规程150HR-SMP-04-009-00物料及成品报损规程151HR-SMP-04-101-00物料接收初验管理规程152HR-SMP-04-102-00物料编码管理规程153HR-SMP-04-103-00物料贮存、养护管理规程154HR-SMP-04-104-00包材、标签、说明书使用管理规程155HR-SMP-04-105-00印刷包装材料设计、审核、批准管理规程156HR-SMP-04-106-00物料出库管理规程157HR-SMP-04-201-00成品入库、养护、出库管理规程158HR-SMP-04-202-00物料退库管理规程159HR-SMP-04-203-00物料贮存期复验管理规程160HR-SMP-04-204-00退货成品管理规程161HR-SMP-04-205-00成品复验管理规程162HR-SMP-04-206-00产品运输管理规程163HR-SMP-04-301-00产品销售管理规程164HR-SMP-04-302-00销售记录管理规程165HR-SMP-04-303-00销售档案管理规程166HR-SMP-04-304-00产品退（换）货管理规程167HR-SMP-04-305-00产品发货管理规程168HR-SMP-04-306-00用户满意度调查管理规程169HR-SMP-05-001-00财务管理规程170HR-SMP-05-002-00财务会计核算管理规程171HR-SMP-05-003-00增值税专用发票管理规程二、工作标准序号文件编号文件名称1HR-SOP-01-001-00企业负责人工作职责2HR-SOP-01-002-00生产管理负责人工作职责3HR-SOP-01-003-00质量管理负责人工作职责4HR-SOP-01-004-00质量受权人工作职责5HR-SOP-01-005-00行政管理部工作职责6HR-SOP-01-006-00行政管理部部长工作职责7HR-SOP-01-007-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R-SOP-02-402-00生姜检验SOP184HR-SOP-02-403-00食醋检验SOP185HR-SOP-02-404-00蜂蜜检验SOP186HR-SOP-02-405-00麦麸检验SOP187HR-SOP-02-406-00黄酒检验SOP188HR-SOP-02-407-00食盐检验SOP189HR-SOP-02-408-00河砂检验SOP190HR-SOP-02-409-00滑石粉检验SOP191HR-SOP-02-410-00大米检验SOP192HR-SOP-02-411-00标签检验SOP193HR-SOP-02-412-00药用塑料袋检验SOP194HR-SOP-02-413-00纸箱检验SOP195HR-SOP-02-414-00塑料编织袋检验SOP196HR-SOP-02-501-00大枣检验SOP197HR-SOP-02-502-00枸杞子检验SOP198HR-SOP-02-503-00牛蒡子检验SOP199HR-SOP-02-504-00款冬花检验SOP200HR-SOP-02-505-00茯苓检验SOP201HR-SOP-02-506-00红花检验SOP202HR-SOP-02-507-00金银花检验SOP203HR-SOP-02-508-00菊花检验SOP204HR-SOP-02-509-00连翘检验SOP205HR-SOP-02-510-00麦冬检验SOP206HR-SOP-02-511-00三七检验SOP207HR-SOP-02-512-00太子参检验SOP208HR-SOP-02-513-00百合检验SOP209HR-SOP-02-514-00山茱萸检验SOP210HR-SOP-02-515-00小茴香检验SOP211HR-SOP-02-516-00干姜检验SOP212HR-SOP-02-517-00板蓝根检验SOP213HR-SOP-02-518-00赤芍检验SOP214HR-SOP-02-519-00党参检验SOP215HR-SOP-02-520-00羌活检验SOP216HR-SOP-02-521-00淫羊藿检验SOP217HR-SOP-02-522-00柴胡检验SOP218HR-SOP-02-523-00大黄检验SOP219HR-SOP-02-524-00黄芩检验SOP220HR-SOP-02-525-00巴戟天检验SOP221HR-SOP-02-526-00锁阳检验SOP222HR-SOP-02-527-00天麻检验SOP223HR-SOP-02-528-00川芎检验SOP224HR-SOP-02-529-00丹参检验SOP225HR-SOP-02-530-00黄连检验SOP226HR-SOP-02-531-00红芪检验SOP227HR-SOP-02-532-00肉苁蓉检验SOP228HR-SOP-02-533-00白术检验SOP229HR-SOP-02-534-00山药检验SOP230HR-SOP-02-535-00薏苡仁检验SOP231HR-SOP-02-536-00牡蛎检验SOP232HR-SOP-02-537-00苦杏仁检验SOP233HR-SOP-02-538-00当归检验SOP234HR-SOP-02-539-00甘草检验SOP235HR-SOP-02-540-00黄芪检验SOP236HR-SOP-02-541-00地黄检验SOP237HR-SOP-03-001-00人员进出生产区更衣SOP238HR-SOP-03-002-00生产废弃物处理SOP239HR-SOP-03-003-00物料进出生产区清洁SOP240HR-SOP-03-004-00领料SOP241HR-SOP-03-005-00剩余物料退库SOP242HR-SOP-03-006-00物料交接SOP243HR-SOP-03-007-00称量SOP244HR-SOP-03-008-00生产区清洁SOP245HR-SOP-03-009-00生产区清洁工具清洁SOP246HR-SOP-03-101-00药材净选SOP247HR-SOP-03-102-00药材清洗SOP248HR-SOP-03-103-00药材软化SOP249HR-SOP-03-104-00药材切制SOP250HR-SOP-03-105-00药材干燥SOP251HR-SOP-03-106-00药材筛选SOP252HR-SOP-03-107-00饮片炙制SOP253HR-SOP-03-108-00炼蜜SOP254HR-SOP-03-109-00辅料配制SOP255HR-SOP-03-110-00饮片炒制SOP256HR-SOP-03-111-00饮片蒸制SOP257HR-SOP-03-112-00饮片煅制SOP258HR-SOP-03-113-00饮片内包装SOP259HR-SOP-03-114-00饮片外包装SOP260HR-SOP-03-201-00物料接收SOP261HR-SOP-03-202-00原辅材料验收入库SOP262HR-SOP-03-203-00原辅材料贮存养护SOP263HR-SOP-03-204-00原辅料发放及退库SOP264HR-SOP-03-203-20包装材料验收入库SOP265HR-SOP-03-206-00包装材料贮存SOP266HR-SOP-03-207-00包装材料发放及退库SOP267HR-SOP-03-208-00包装材料更换SOP268HR-SOP-03-209-00标签验收入库、贮存、发放及退库SOP269HR-SOP-03-210-00成品入库验收SOP270HR-SOP-03-211-00成品贮存养护SOP271HR-SOP-03-212-00成品发放SOP272HR-SOP-03-213-00仓库温湿度监控SOP273HR-SOP-03-214-00仓库清洁SOP274HR-SOP-03-215-00成品发运SOP275HR-SOP-03-216-00物料代码编制SOP276HR-SOP-03-217-00中药材、中药饮片养护SOP277HR-SOP-03-218-00不合格品销毁SOP278HR-SOP-03-219-00物料补发SOP279HR-SOP-03-220-00物料复检SOP280HR-SOP-03-301-00厂房设施设备编号SOP281HR-SOP-03-302-00设备关键等级评估SOP282HR-SOP-03-303-00计量器具关键等级评估SOP283HR-SOP-03-304-00设备仪器用户需求计划SOP284HR-SOP-03-401-00自动干手器使用维护保养SOP285HR-SOP-03-402-00自动干手器维护保养SOP286HR-SOP-03-403-00电子秤操作SOP287HR-SOP-03-404-00电子秤维护保养SOP288HR-SOP-03-405-00电子台秤操作SOP289HR-SOP-03-406-00磅秤维护保养SOP290HR-SOP-03-407-00XY-700循环水洗药机SOP291HR-SOP-03-408-00XY-700循环水洗药机维护保养SOP292HR-SOP-03-409-00QY-300高速裁断往复式切药机SOP293HR-SOP-03-410-00QY-300高速裁断往复式切药机维护保养SOP294HR-SOP-03-411-00ZQY-100转盘式切药机SOP295HR-SOP-03-412-00ZQY-100转盘式切药机维护保养SOP296HR-SOP-03-413-00烘房使用SOP297HR-SOP-03-414-00烘房维护保养SOP298HR-SOP-03-415-00SX-3振动筛选机使用SOP299HR-SOP-03-416-00SX-3振动筛选机维护保养SOP300HR-SOP-03-417-00LM-600炼蜜锅使用SOP301HR-SOP-03-418-00LM-600炼蜜锅维护保养SOP302HR-SOP-03-419-00ZZ-700蒸煮锅SOP303HR-SOP-03-420-00ZZ-700蒸煮锅维护保养SOP304HR-SOP-03-421-00CY-700煤加热炒药机SOP305HR-SOP-03-422-00CY-700煤加热炒药机维护保养SOP306HR-SOP-03-423-00快速脚踏封口机SOP307HR-SOP-03-424-00快速脚踏封口机维护保养SOP308HR-SOP-03-501-00计量校准SOP309HR-SOP-03-502-00标准器检定审核和评估SOP310HR-SOP-03-503-00电子台秤校准SOP311HR-SOP-03-504-00电子计价秤校准SOP312HR-SOP-03-505-00箱式电阻炉校准SOP313HR-SOP-03-506-00酸度计校准SOP314HR-SOP-03-507-00工作用玻璃液体温度计校准SOP315HR-SOP-03-508-00高效液相色谱仪校准SOP316HR-SOP-03-601-00验证总计划编制审批SOP317HR-SOP-03-602-00前验证SOP318HR-SOP-03-603-00同步验证SOP319HR-SOP-03-604-00回顾性验证SOP320HR-SOP-03-605-00再验证SOP321HR-SOP-03-603-60变更验证SOP322HR-SOP-03-607-00厂房设施确认SOP323HR-SOP-03-608-00设备确认SOP324HR-SOP-03-609-00检验方法验证SOP325HR-SOP-03-610-00清洁验证SOP326HR-SOP-03-611-00生产工艺验证SOP327HR-SOP-03-612-00验证报告SOP328HR-SOP-03-613-00检验仪器确认SOP329HR-SOP-04-001-00物料采购SOP330HR-SOP-04-002-00销售退货质量评估SOP331HR-SOP-04-003-00用户访问SOP三、技术标准序号文件编号文件名称1HR-STP-02-001-00水分测定法2HR-STP-02-002-00灰分测定法3HR-STP-02-003-00浸出物测定法4HR-STP-02-004-00薄层色谱法5HR-STP-02-005-00高效液相色谱法6HR-STP-02-006-00电位滴定法与永停滴定法7HR-STP-02-007-00相对密度测定法8HR-STP-02-008-00酸败度检查法9HR-STP-02-009-00杂质检测法10HR-STP-02-010-00pH测定法11HR-STP-02-011-00干燥失重测定法12HR-STP-02-012-00炽灼残渣检查法13HR-STP-02-013-00挥发油测定法14HR-STP-02-014-00显微鉴别法15HR-STP-02-015-00重金属检查法16HR-STP-02-016-00紫外可见分光光度法17HR-STP-02-017-00膨胀度测定法18HR-STP-02-018-00一般鉴别试验法19HR-STP-02-019-00鞣质含量测定法20HR-STP-02-020-00农药残留量测定法21HR-STP-02-021-00铅、镉、砷、汞、铜测定法22HR-STP-02-022-00原子吸收分光光度法23HR-STP-02-023-00气相色谱法24HR-S