GMP文件目录.doc

生产质量管理文件目录一 机构与人员（一）管理制度1员工进厂培训制度···································GB-JR-A001002员工业务学习管理制度·······························GB-JR-A002003员工培训管理制度···································GB-JR-A003004人员考核聘用制度···································GB-JR-A004005人员定期体检管理制度·······························GB-JR-A005006公司组织机构定编、定岗管理制度·····················GB-JR-A006007公司人员录用、晋级、解聘管理制度····················GB-JR-A007008员工仪表及行为管理制度·····························GB-JR-A008009质量管理、检验人员的培训和考核管理制度··············GB-JR-A0090010考勤、请假、休假管理制度···························GB-JR-A0100011员工婚育管理制度··································GB-JR-A01100（二）部门及人员职责1总经理岗位职责·····································ZB-JR-A001002生产总监岗位职责···································ZB-JR-A002003财务总监岗位职责···································ZB-JR-A003004 GMP认证办公室职责··································ZB-JR-A004005 GMP认证办公室管理员岗位职责························ZB-JR-A005006综合事务部职责·····································ZB-JR-A006007综合事务部部长岗位职责·····························ZB-JR-A007008办公室文秘岗位职责·································ZB-JR-A008009法务岗位职责·······································ZB-JR-A0090010综合事务部人事管理员岗位职责······················ZB-JR-A0100011综合事务部后勤管理员岗位职责······················ZB-JR-A0110012档案管理员岗位职责································ZB-JR-A0120013保卫科职责········································ZB-JR-A0130014保卫科科长岗位职责································ZB-JR-A0140015警卫员岗位职责····································ZB-JR-A0150016驾驶员岗位职责····································ZB-JR-A0160017厂区绿化工岗位职责································ZB-JR-A0170018厂区清洁员岗位职责································ZB-JR-A0180019财务部职责········································ZB-JR-A0190020财务主管岗位职责··································ZB-JR-A0200021出纳岗位职责······································ZB-JR-A0210022材料会计岗位职责··································ZB-JR-A0220023财务核算员岗位职责································ZB-JR-A0230024生产管理部职责····································ZB-JR-A0240025生产管理部部长岗位职责····························ZB-JR-A0250026生产管理部调度员岗位职责··························ZB-JR-A0260027生产管理部统计员岗位职责··························ZB-JR-A0270028生产管理部设备员岗位职责··························ZB-JR-A0280029技术改造员岗位职责································ZB-JR-A0290030 101车间职责·······································ZB-JR-A0300031 101车间主任岗位职责·······························ZB-JR-A0310032 101车间中化室负责人岗位职责·······················ZB-JR-A0320033 101车间工艺员岗位职责·····························ZB-JR-A0330034 101车间中化室检验员岗位职责······················ZB-JR-A0340035 101车间领料员岗位职责····························ZB-JR-A0350036 101车间统计员岗位职责·····························ZB-JR-A0360037 101车间质量巡检员岗位职责·························ZB-JR-A0370038 101车间机修工岗位职责·····························ZB-JR-A0380039 101车间电工岗位职责·······························ZB-JR-A0390040 101车间工服洗涤工岗位职责·························ZB-JR-A0400041合成、精烘包工段长岗位职责·························ZB-JR-A0410042还原环合岗位班组长岗位职责························ZB-JR-A0420043环合物离心岗位班组长岗位职责······················ZB-JR-A0430044氟化水解岗位班组长岗位职责························ZB-JR-A0440045粗品离心岗位班组长岗位职责························ZB-JR-A0450046溶解脱色压滤岗位班组长岗位职责····················ZB-JR-A0460047结晶、离心、干燥、 粉碎岗位班组长岗位职责···········ZB-JR-A0470048混合包装岗位班组长岗位职责························ZB-JR-A0480049纯化水制备岗位班组长岗位职责······················ZB-JR-A0490050 101车间操作工岗位职责·····························ZB-JR-A0500051动力车间职责······································ZB-JR-A0510052动力车间主任职责··································ZB-JR-A0520053冷冻站岗位职责····································ZB-JR-A0530054冷冻工段长岗位职责································ZB-JR-A0540055一次水操作工岗位职责······························ZB-JR-A0550056循环水操作工岗位职责······························ZB-JR-A0560057污水处理站职责····································ZB-JR-A0570058污水处理站工段长岗位职责··························ZB-JR-A0580059污水处理站操作工岗位职责··························ZB-JR-A0590060锅炉工段岗位职责··································ZB-JR-A0600061锅炉工段长岗位职责································ZB-JR-A0610062司炉工岗位职责····································ZB-JR-A0620063供配电站职责······································ZB-JR-A0630064供配电站工段长岗位职责····························ZB-JR-A0640065电工岗位职责······································ZB-JR-A0650066仪表工岗位职责····································ZB-JR-A0660067机修工段长岗位职责································ZB-JR-A0670068机修工岗位职责····································ZB-JR-A0680069质量保证部职责····································ZB-JR-A0690070质量保证部部长职责································ZB-JR-A0700071质量保证部QC职责·································ZB-JR-A0710072质量保证部QC主任职责······························ZB-JR-A0720073质量保证部QA职责··································ZB-JR-A0730074质量保证部QA主任职责······························ZB-JR-A0740075质量保证部QA质监员职责····························ZB-JR-A0750076质量保证部QC化验员职责···························ZB-JR-A0760077兽药不良反应监测小组职责··························ZB-JR-A0770078储运部职责········································ZB-JR-A0780079储运部部长岗位职责································ZB-JR-A0790080发货员岗位职责····································ZB-JR-A0800081采购员岗位职责····································ZB-JR-A0810082库管员岗位职责····································ZB-JR-A0820083动力车间主任安全职责······························ZB-JR-A0830084总经理安全职责····································ZB-JR-A0840085安全生产委员会职责································ZB-JR-A0850086安委会办公室职责··································ZB-JR-A0860087财务部安全职责····································ZB-JR-A0870088综合事务部安全职责································ZB-JR-A0880089保卫、消防队安全职责·······························ZB-JR-A0890090质量保证部安全职责································ZB-JR-A0900091生产管理部安全职责································ZB-JR-A0910092生产调度室安全职责································ZB-JR-A0920093生产调度员安全职责································ZB-JR-A0930094储运部安全职责····································ZB-JR-A0940095安全主管安全职责··································ZB-JR-A0950096设备主管安全职责··································ZB-JR-A0960097 101车间主任安全职责······························ZB-JR-A0970098工段长安全职责····································ZB-JR-A0980099车间技术员安全职责································ZB-JR-A09900100车间班组长安全职责·······························ZB-JR-A10000101生产工人安全职责·································ZB-JR-A10100102动力车间安全职责·································ZB-JR-A10200103溴代水解、缩合工段长岗位职责······················ZB-JR-A10300104溴代岗位班组长岗位职责···························ZB-JR-A10400105水解岗位班组长岗位职责···························ZB-JR-A10500106溴素回收岗位班组长岗位职责·······················ZB-JR-A10600107 L酯制铜盐岗位班组长岗位职责······················ZB-JR-A10700108缩合岗位班组长岗位职责···························ZB-JR-A10800109缩合压滤岗位班组长岗位职责·······················ZB-JR-A10900110缩合干燥岗位班组长岗位职责·······················ZB-JR-A11000111缩合硫酸铜回收岗位班组长岗位职责·················ZB-JR-A11100112酯化、拆分工段长岗位职责··························ZB-JR-A11200113酯化岗位班组长岗位职责···························ZB-JR-A11300114酯化一次乙醇回收岗位班组长岗位职责···············ZB-JR-A11400115酯化压滤岗位班组长岗位职责·······················ZB-JR-A11500116酯化除铜脱色岗位班组长岗位职责···················ZB-JR-A11600117酯化离心干燥岗位班组长岗位职责···················ZB-JR-A11700118拆分岗位班组长岗位职责···························ZB-JR-A11800119拆分L酯回收岗位班组长岗位职责····················ZB-JR-A11900120拆分压滤岗位班组长岗位职责·······················ZB-JR-A12000121拆分离心岗位班组长岗位职责·······················ZB-JR-A12100122拆分游离脱色岗位班组长岗位职责···················ZB-JR-A12200123拆分干燥岗位班组长岗位职责·······················ZB-JR-A12300二 厂房与设施（一）管理制度1厂房设计管理制度···································GB-CS-A001002厂房施工管理制度···································GB-CS-A002003人流通道、物流通道管理制度·························GB-CS-A003004厂房维护保养管理制度·······························GB-CS-A004005厂房验收管理制度···································GB-CS-A005006危险品库管理制度···································GB-CS-A006007洁净厂房管理制度···································GB-CS-A007008管道与配套设施管理制度·····························GB-CS-A008009循环水设施管理制度·································GB-CS-A0090010冷冻设施管理制度··································GB-CS-A0100011电气设施管理制度··································GB-CS-A0110012暖气设施的管理制度································GB-CS-A0120013压力表、真空表检定管理制度·························GB-CS-A0130014蒸汽设施管理制度··································GB-CS-A01400三 设备（一）管理制度1检验用仪器、设备管理制度···························GB-SB-A001002设备编号管理制度···································GB-SB-A002003设备的选型与购置管理制度···························GB-SB-A003004设备开箱检查、验收管理制度·························GB-SB-A004005设备的备品备件管理制度·····························GB-SB-A005006设备的安装、调试、验收管理制度·····················GB-SB-A006007设备的更新、改造、报废和调拨管理制度···············GB-SB-A007008设备的润滑管理制度································GB-SB-A008009设备的维修、保养管理制度···························GB-SB-A0090010设备管道涂色及管道内容物标识管理制度··············GB-SB-A0100011封存设备与闲置设备管理制度························GB-SB-A0120012设备状态标志管理制度······························GB-SB-A0130013叉车使用管理制度··································GB-SB-A0140014设备事故管理制度··································GB-SB-A0150015锅炉、压力容器及特种设备管理制度···················GB-SB-A0160016设备档案管理制度··································GB-SB-A01700（二）生产用设备标准操作规程1三足式离心机标准操作规程···························ZB-SB-A001002 SPBZ-L/W-180卧式水喷射真空机组标准操作规程···········ZB-SB-A002003 B-0.9/7、B-1.5/12移动式空压机标准操作规程···········ZB-SB-A003004 CD1-9电动葫芦标准操作规程··························ZB-SB-A004005 SZG双锥回转真空干燥机标准操作规程··················ZB-SB-A005006 ZCF-30000/8型低温液氮贮槽标准操作规程··············ZB-SB-A006007 IMC50-32-200氟合金磁力泵标准操作规程···············ZB-SB-A007008合成SCS-2电子地上衡标准操作规程···················ZB-SB-A008009反冲式压滤机标准操作规程···························ZB-SB-A0090010 GFG300高效沸腾干燥机标准操作规程················ZB-SB-A0100011三足式洁净型离心机标准操作规程···················ZB-SB-A0110012 30B型粉碎机标准操作规程··························ZB-SB-A0120013热打码机标准操作规程······························ZB-SB-A0130014洁净区传递窗标准操作规程··························ZB-SB-A0140015 TCS-150电子台秤标准操作规程·······················ZB-SB-A0150016 LKHY-SP-8T型纯化水制备系统标准操作规程············ZB-SB-A0160017 ZKW-50000组合式空调机组标准操作规程···············ZB-SB-A0170018洁净区洗衣机标准操作规程··························ZB-SB-A0180019反应釜标准操作规程································ZB-SB-A0190020不锈钢磁力泵标准操作规程··························ZB-SB-A0200021 QBY-40气动隔膜泵标准操作规程······················ZB-SB-A0210022饮用水净水机标准操作规程··························ZB-SB-A0220023封口机机标准操作规程······························ZB-SB-A0230024移动式捕尘器标准操作规程··························ZB-SB-A0240025圆筒式压滤机标准操作规程··························ZB-SB-A0250026 CT-C-型热风循环烘箱标准操作规程················ZB-SB-A0260027 BAY630/10-u板框压滤机标准操作规程·············ZB-SB-A0270028 G40-2螺杆泵标准操作规程··························ZB-SB-A0280029 2BVA6111水环式真空泵标准操作规程··················ZB-SB-A0290030离心泵标准操作规程································ZB-SB-A0300031塘玻璃冷凝器标准操作规程··························ZB-SB-A0310032 YK-160型摇摆式颗粒机标准操作规程··················ZB-SB-A0320033 EYH-2000两维运动混合机标准操作规程················ZB-SB-A03300（三）检验用设备标准操作规程1 AB135-S型双量程电子天平标准操作规程················ZB-SB-B001002 AL104/01电子天平标准操作规程·······················ZB-SB-B002003 ZDJ-2S卡氏微量水份测定仪标准操作规程···············ZB-SB-B003004 LDZX-40KB立式压力蒸汽灭菌器标准操作规程···········ZB-SB-B004005 DHS20-A多功能红外水份测定仪标准操作规程···········ZB-SB-B005006 HH4（双列）数显恒温水浴锅标准操作规程···········ZB-SB-B006007 SPX-160B生化培养箱标准操作规程····················ZB-SB-B007008 DGX鼓风干燥箱标准操作规程·························ZB-SB-B008009 DHG型电热恒温鼓风干燥箱标准操作规程················ZB-SB-B0090010 WZZ自动旋光仪标准操作规程························ZB-SB-B0100011 CLJ-B型激光尘埃粒子计数器标准操作规程···········ZB-SB-B0110012 YP2001N电子天平标准操作规程·······················ZB-SB-B0120013 TD型电子天平标准操作规程··························ZB-SB-B0130014 FA1004N电子天平标准操作规程·······················ZB-SB-B0140015 MP型电子天平标准操作规程··························ZB-SB-B0150016 101数显电热鼓风干燥箱标准操作规程·················ZB-SB-B0160017 DDS-11A型电导率仪标准操作规程·····················ZB-SB-B0170018 DK型电热恒温水浴槽标准操作规程···················ZB-SB-B0180019 756MC紫外分光光度计标准操作规程··················ZB-SB-B0190020 DKU-30型电热恒温油槽标准操作规程··················ZB-SB-B0200021 DZF型真空干燥箱标准操作规程·······················ZB-SB-B0210022 WRR熔点仪标准操作规程·····························ZB-SB-B0220023 2XZ型旋片式真空泵标准操作规程·····················ZB-SB-B0230024 ZD-2型自动电位滴定仪标准操作规程··················ZB-SB-B0240025 SZ-93自动双重纯水蒸馏器标准操作规程···············ZB-SB-B0250026 RE-2000旋光蒸发器标准操作规程····················ZB-SB-B0260027 SX2箱式电阻炉标准操作规程························ZB-SB-B0270028 PHS-3C型精密PH计标准操作规程·····················ZB-SB-B0280029 GC-14C气相色谱仪标准操作规程·····················ZB-SB-B0290030 LC-20A液相色谱仪标准操作规程·····················ZB-SB-B0300031 101电热鼓风干燥箱标准操作规程····················ZB-SB-B0310032 ZDJ-2S卡氏微量水份测定仪自校标准操作规程··········ZB-SB-B0320033 WRR熔点仪自校标准操作规程·························ZB-SB-B03300（四）生产用设备维护、保养、清洁标准操作规程1三足式离心机维护、保养、清洁标准操作规程···········ZB-SB-C001002 SPBZ-L/W-180水喷射式真空机组维护、保养、清洁标准操作规程···············ZB-SB-C002003 B-0.9/7、B-1.5/12移动式空压机维护、保养、清洁标准操作规程··················ZB-SB-C003004 SZG2000双锥回转干燥机维护、保养、清洁标准操作规程··ZB-SB-C004005母液池清洁标准操作规程·····························ZB-SB-C005006 GFG-300高效沸腾干燥机维护、保养、清洁标准操作规程·ZB-SB-C006007 反冲式压滤机维护、保养、清洁标准操作规程···········ZB-SB-C007008 三足式洁净型离心机维护、保养、清洁标准操作规程······ZB-SB-C008009 30B型带除尘粉碎机维护、保养、清洁标准操作规程·······ZB-SB-C0090010纯化水生产线、贮罐及输送管道维护、保养标准操作规程··ZB-SB-C0100011反渗透膜清洁标准操作规程··························ZB-SB-C0110012空调机组维护、保养、清洁、消毒标准操作规程·········ZB-SB-C0120013仪器、仪表维护、保养标准操作规程···················ZB-SB-C0130014反应釜维护、保养、清洁标准操作规程·················ZB-SB-C0140015电子地上衡维护、保养、清洁标准操作规程·············ZB-SB-C0150016洁净区洗衣机维护、保养、清洁标准操作规程············ZB-SB-C0160017 ZCF-30000/8低温液氮贮槽维护、保养、清洁标准操作规程·ZB-SB-C0170018防爆电动葫芦维护、保养、清洁标准操作规程··············ZB-SB-C0180019洁净区传递窗维护保养清洁标准操作规程··············ZB-SB-C0190020 QBY-40气动隔膜泵维护保养清洁标准操作规程··········ZB-SB-C0200021饮用水净水机维护、保养、清洁标准操作规程···········ZB-SB-C0210022移动式捕尘器维护、保养、清洁标准操作规程············ZB-SB-C0220023搪玻璃冷凝器维护保养清洁标准操作规程·············ZB-SB-C0230024 2BV6111水环式真空泵维护、保养、清洁标准操作规程·····ZB-SB-C0240025 G40-2螺杆泵维护、保养、清洁标准操作规程·············ZB-SB-C0250026离心泵维护、保养标准操作规程······················ZB-SB-C0260027圆筒压滤机维护、保养、清洁标准操作规程··············ZB-SB-C0270028 CT-C-型热风循环烘箱维护、保养、清洁标准操作规程···ZB-SB-C0280029板框压滤机维护、保养、清洁标准操作规程··············ZB-SB-C0290030 YK型摇摆颗粒机维护、保养、清洁标准操作规程··········ZB-SB-C0300031 EYH两维运动混合机维修、保养、清洁标准操作规程·······ZB-SB-C03100（五）检验用设备维护、保养、清洁标准操作规程1 AB135-S型双量程电子天平维护、保养、清洁规程·········ZB-SB-D001002 AL104/01电子天平维护、保养、清洁规程················ZB-SB-D002003 ZDJ-2S卡氏微量水份测定仪维护、保养、清洁规程·········ZB-SB-D003004 LDZX-40KB立式压力蒸汽灭菌器维护、保养、清洁规程······ZB-SB-D004005 DHS20-A多功能红外水份测定仪维护、保养、清洁规程······ZB-SB-D005006 HH4（双列）数显恒温水浴锅维护、保养、清洁规程········ZB-SB-D006007 SPX-160B生化培养箱维护、保养、清洁规程···············ZB-SB-D007008 DGX鼓风干燥箱维护、保养、清洁规程·················ZB-SB-D008009 DHG型电热恒温鼓风干燥箱维护、保养、清洁规程··········ZB-SB-D0090010 WZZ自动旋光仪维护、保养、清洁规程···················ZB-SB-D0100011 CL