GMP英文单词

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 Hard 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 Quality 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 Room Management of Standard Operating Procedures (SOP) Management of Technical Documents Guidelines for Sampling General Guidelines for Quality Control Management of Reference Materials (Standard Materials) Management of Titrants, Standard Solutions and Reagents General Guidelines for Validation Operation and Maintenance of Analytical Instruments Management of Data Records and Documents Cleaning of Production Equipment Numbering of Production Equipment Internal GMP Audit Procedure for Product Quality Review Guideline for Facility Sanitation and Safety Material Management Batch Number Assignment Deviation Report and Handling Handling of Rejected Materials Handling Out-of-Specification Results Release of Materials Guidelines for Change Control Quality Audit and Management for Suppliers General Guidelines for Reprocessing Recycling of Mother Liquors and Reagents Drafting Stability Protocols Defining Manufacturing Date and Retest Date QC Test Specification Guidelines for Ordinary Retention Laboratory Safety Complaint Handling Guidelines of Check-ups for Production Personnel Management of Material Code Number General Requirements for Personnel and Environment in Clean Rooms Procedure for Postproduction Clearance Maintenance of Production and Cleaning Equipment in Clean Rooms Management of Working Garments in Clean Rooms Product Packaging and Labeling Guidelines for Material Weighing Responsibility and Power of Quality Assurance Department Warehousing and Distribution of Raw Materials and Packaging Materials Storage of Materials Degraded Use of Raw Materials and Packaging Materials Warehousing and Distribution of Products Management of Measuring Instruments Numbering of Measuring Instruments Metrological Certification and Usage of Measuring Instruments Class A, B, C Management of Measuring Instruments Reporting Program of Out-of-Calibration Measuring Instruments Maintenance of Production Equipment Personnel Training Program Waste Handling of Anti-cancer Products Guideline for Documentation Review Corrective Actions and Preventative Actions (CAPA) Data Backup of Chromatographic Working Station Management of Forms, Sheets, Labels and Stickers GMP Site Inspection 标准操作程序（SOP）管理办法 技术文件管理办法 抽样#管理# 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 生产设备清洗规定 生产设备编号管理办法 企业内部GMP自检(内部审计)制度 产品质量审核 工厂的清洁、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 生产日期、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 人员制度 抗肿瘤类废弃物处理办法 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 记录格、标牌和贴签管理规定 GMP现场检查