1、更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning Tools Room清洗室 Cleaning Room模具室 Dies Room内包装室 Immediate Package Room安全门 Emergency Door外包清室 Outer Package Removing Room存料间 Storage Room of Raw Materials粉碎室 Pulverizing Room备料室 Materials Preparing Room硬胶室 Har
2、d Capsules Filling Room软胶室 Soft Capsules Room制粒干燥室Granulating and Drying Room总混间 Blending Room中间站 Intermediate Station压片室 Tablets Room Compression Room包衣室 Coating Room配浆间 Coating Mixture Preparing Room铝塑包装间 Packing Room传递窗 Transferring Window外包装室 Outer Packing Room蒸馏水室 Water Purifying Room质检室 Qualit
3、y Control Room浓配室 Concentrated Solution Room稀配室 Diluted Solution Room灌封室 Filling and Sealing Room存瓶室 Ampul Storage Room洗瓶室 Ampul Cleaning Room灭菌间 Sterilizing Room灯检室 Light Inspection Room粉针室 Lyophilized Sterile Powder RoomManagement of Standard Operating Procedures (SOP)Management of Technical Docum
4、entsGuidelines for SamplingGeneral Guidelines for Quality ControlManagement of Reference Materials (Standard Materials)Management of Titrants, Standard Solutions and ReagentsGeneral Guidelines for ValidationOperation and Maintenance of Analytical InstrumentsManagement of Data Records and DocumentsCl
5、eaning of Production EquipmentNumbering of Production EquipmentInternal GMP AuditProcedure for Product Quality ReviewGuideline for Facility Sanitation and SafetyMaterial ManagementBatch Number AssignmentDeviation Report and HandlingHandling of Rejected MaterialsHandling Out-of-Specification ResultsR
6、elease of MaterialsGuidelines for Change ControlQuality Audit and Management for SuppliersGeneral Guidelines for ReprocessingRecycling of Mother Liquors and ReagentsDrafting Stability Protocols标准操作程序（SOP）管理办法技术文件管理办法抽样管理制度质量检验制度对照品（标准品）管理办法滴定液、标准液和试剂的管理验证管理分析测试仪器设备的使用和维护保养数据记录与记录文件管理规定生产设备清洗规定生产设备编号
7、管理办法企业内部 GMP 自检( 内部审计) 制度产品质量审核工厂的清洁、安全管理规定生产部门物料管理批号编制规定偏差报告和调查处理不合格品的处理O-O-S 结果调查程序物料放行变更控制程序供应商质量审计管理办法产品返工的有关规定母液回收和溶剂回收管理药品稳定性试验管理Defining Manufacturing Date and Retest DateQC Test SpecificationGuidelines for Ordinary RetentionLaboratory SafetyComplaint HandlingGuidelines of Check-ups for Produ
8、ction PersonnelManagement of Material Code NumberGeneral Requirements for Personnel and Environment in Clean RoomsProcedure for Postproduction ClearanceMaintenance of Production and Cleaning Equipment in Clean RoomsManagement of Working Garments in Clean RoomsProduct Packaging and LabelingGuidelines
9、 for Material WeighingResponsibility and Power of Quality Assurance DepartmentWarehousing and Distribution of Raw Materials and Packaging MaterialsStorage of MaterialsDegraded Use of Raw Materials and Packaging MaterialsWarehousing and Distribution of ProductsManagement of Measuring InstrumentsNumbe
10、ring of Measuring InstrumentsMetrological Certification and Usage of Measuring InstrumentsClass A, B, C Management of Measuring InstrumentsReporting Program of Out-of-Calibration Measuring InstrumentsMaintenance of Production EquipmentPersonnel Training ProgramWaste Handling of Anti-cancer Products生
11、产日期、复测期的标注检验分析技术标准常规留样管理办法化验室安全操作投诉处理药品生产人员体检管理办法物料代号管理规定洁净室（区）人员、环境管理规定清场验收制度清洁工具、生产用具管理办法洁净区工作服管理办法成品的包装和贴签物料称量的规定QA 的职责和权力原料、包材的入库验收和发放物料的贮存原料、包材的降格使用规定成品的入库和发放计量器具管理制度计量器具编号规定计量器具印证使用管理办法计量器具 A,B,C 三级管理办法计量器具失准报告程序生产设备的维护和维修保养人员培训制度抗肿瘤类废弃物处理办法Guideline for Documentation ReviewCorrective Actions and Preventative Actions (CAPA)Data Backup of Chromatographic Working StationManagement of Forms, Sheets, Labels and StickersGMP Site Inspection文件审核细则缺陷的整改和预防（CAPA）色谱工作站数据的备份记录表格、标牌和贴签管理规定GMP 现场检查
