GMP中英文单词对照表.docx

1GMP 中英文单词对照表中英文单词对照表GMP (Good Manufacturing Practice)药品生产质量管理规范FDA (Food and Drug Administration)食品药品监督管理局EMEA (European Medicines Evaluation Agency)欧洲药品管理局QRM (Quality Risk Management)质量风险管理Q M （Quality Management System）质量管理体系QA (Quality Assurance)质量保证QC （Quality Control）质量控制Senior /Top Management高层管理者Quality Policy质量方针Quality Objective质量目标Quality Planning质量计划Resource Management资源管理Internal Communication信息交流Continuous Improvement持续改进Management Review管理评审Process Approach过程方法QP（Qualified Person）质量授权人AP (Authorized Person)授权人URS (User Requirement Specification)用户需求说明Commissioning试运行FAT（Factory Acceptance Test）工厂的验收测试SAT (Site Acceptance Test)用户工程的验收测试Functional Specification功能标准Qualification确认Calibration校准Preventive Maintenance预防性维护SOP （Standard operation procedure）标准操作程序2Retirement Management退役管理Equipment Logbook设备使用日志IPC （In-process controls）中间（过程）控制CPP (Critical Process parameters)关键工艺参数CQA (Critical Quality Attributes)关键质量特性Reprocessing 返工Reworking重新加工VMP ( Validation Master Plan) 验证总计划URS（User Requirement Specification)用户需求说明文件TS （Technical Specification)技术标准文件IQ (Installation Qualification)安装确认OQ (Operation Qualification )运行确认PQ (Performance Qualification)性能确认DQ （Design Qualification）设计确认Master Batch Record基准批记录Process Design工艺设计Process Qualification工艺确认PPQ （Process Performance Qualification）工艺性能确认Continued Process Verification持续工艺核实Prospective Validation介绍的前验证3Concurrent Validation同步验证Retrospective Validation回顾性验证CIP（ Cleaning In Place ）在位清洁RF （ Recovery Factor ）回收因子CS (Computerized System)计算计划系统CSV (Computerized System Validation)计算机化系统验证QBD（Quality By Design）质量源于设计System Specification确定系统标准Functional Specification 硬件标准、功能标准Configuration Specification配置标准Design Specification设计标准Configuration Management配置管理Business Continuity Plan业务持续计划Disaster Recovery Plan灾难恢复计划Backup system备份系统Restore恢复Project Manager项目负责人Process Owner业务流程负责人Responsible User责任用户System Owner计算机系统负责人Key User关键用户4Supplier /Developer供应商/开发者Controlling System控制系统Major Deviation/ Critical Deviation 重大偏差/ 关键偏差CAPA(Corrective Action and Preventive Action)纠正与预防措施Planed Temporary Deviations计划内暂时性偏差Unplanned Deviations计划外偏差CFT（Cross-Functional Team）跨职能（科学）团队Remedial Action矫正措施OOS (Out of Specification)偏差调查和实验室超标结果PAR（Annual Product review）产品年度回顾Risk Identification风险识别Collect and Organize Information收集和组织信息Risk analysis /evaluation/reduction/acceptance风险分析/评估/降低/接收RRF（Risk Ranking and Filtering）风险排列和过滤PHA ( Preliminary Hazard Analysis)初步危害分析FMEA (Failure Mode Effects Analysis)失败模式效果分析Hazard Analysis and Critical Control Point危害分析和关键控制点FAT（Fault Tree Analysis）过失树分析BR ( Batch Record)批记录FAT (Factory Acceptance Test)工厂验收测试PLC（Programmable Logical control）可编程逻辑控制器Metrology Confirmation计量确认Drinking water饮用水5Purified water 纯化水Sterile Purified water灭菌纯化水FDS（Functional Design Specification）功能设计技术说明书DDS（Detailed Design Specification）详细设计技术说明Impact Assessment影响评估COD (Critical Operating Data)关键运行数据Impurity profile杂质档案GEP（Good Engineering Practice）良好工程实践Maintenance Basic Practice基本维护实践Rechecked 复验Audit Trail审查追踪Non-value added不增加价值的Read-only CDs只读式光盘Master Production and Control Record主生产和控制记录Starting Materials起始物料reagents试剂solvents溶剂Process aids工业助剂intermediates中间体APIs原料药Quality Agreement质量协议6Retest Date复验期Holding Time保存期限PV（Process Verification）工艺验证HPL（High Performance Liquid Chromatograph）高效液相色谱仪MRP(Manufacture Resource Planning)制造需求计划ERP（enterprise Resource Planning）企业资源计划WMS（warehouse management system）仓储管理系统RFID（Radio frequency identification）无线射频识别。