制药英文缩写词表.doc

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1、精品文档，仅供学习与交流，如有侵权请联系网站删除常见词汇缩写英文缩写英文全称中文AAC Air Conditioner空调ADR Adverse Drug Reaction药品不良反应AHUAir Handling Unit空气处理单元APIActive Pharmaceutical Ingredient活性药物组分（原料药）ANDAAbbreviated New Drug Application简略新药申请AQLAcceptable Quality Level可接受质量水平ASM Active Substance Manufacturer活性物质生产商ASMEAmerican Society

2、 of Mechanical Engineers 美国机械工程师协会BBMSBuilding Monitoring System 楼宇监测系统BOM Bill of Material物料清单BPBritish Pharmacopoeia英国药典BPCBulk pharmaceutical Chemicals原料药CCAPA Corrective and Preventive Action纠正预防措施CCAComponent Criticality Assessment组件关键性评估CEPCertificate of Suitability for European Pharmacopeia欧洲

3、药典适用性证书CFRCode of Federal Regulations美国联邦法规CFU Colony Forming Unit菌落形成单位CHWChilled Water冷冻水CIP Clean in Place在线清洗CIPCCritical In-Process Control关键中间控制点CNCControlled Non-Classified 控制但未分级COA Certificate of Analysis分析报告单COMCommissioning试车COPClean out of Place离线清洗CPPCritical Process Parameter关键工艺参数CQAC

4、ritical Quality Attribute关键质量属性CROContract Research Organization合同研究组织（外包）CSComputerized System计算机系统CTD Common Technical Document通用技术文件CVCleaning Validation清洁验证CMCChemistry Manufacturing Control化学制造控制DDMFDrug Master File药物主文件DSDesign Specification 设计说明EEDQMEuropean Directorate for the Quality of Med

5、icines & HealthCare欧洲药品与健康质量理事会EHSEnvironment, Health and Safety 环境、健康和安全EMAEuropean Medicines Agency欧洲药监局EP European Pharmacopoeia欧洲药典FFATFactory Acceptance Test 出厂验收测试FDAFOOD AND DRUG ADMINISTRATION（美国）食品药品监督管理局FDSFunction Design Specification功能设计说明FEMAFailure Mode and Effects Analysis 失效模式及后果分析FF

6、UFan Filter Unit风机过滤单元FMSFacility Monitoring System设施监控系统FSFunctional Specification功能说明GGAMPGood Automated Manufacturing Practice优良自动化生产管理规范GCP Good Clinical Practice药品临床研究管理规范GEPGood Engineering Practice优良工程管理规范GLP Good Laboratory Practice药品临床前安全性研究质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范GSP

7、Good Supply Practice药品经营质量管理规范HHACCPHazard Analysis and Critical Control Point危害分析和关键环节控制点HEPAHigh Efficiency Particulate Air高效空气过滤器HMIHuman Machine Interface 人机界面HVAC Heating Ventilation Air Conditioning供热、通风与空调系统IICH International Conference on Harmonisation of Technical Requirements for Registrat

8、ion of Pharmaceuticals for Human Use人用药品注册技术要求国际协调会INDINVESTIGATIONAL NEW DRUG临床研究申请INN International Non-proprietary Name国际非专利名IQInstallation Qualification 安装确认ISPEInternational Society for Pharmaceutical Engineering国际制药工程协会LLIMSLaboratory Information Management System实验室信息管理系统MMA Marketing Authori

9、sation上市许可MAA Marketing Authorisation Application上市申请MBRMaster Batch Record主生产批记录NNDANEW DRUG APPLICATION新药申请OQAQuality Assurance质量保证QbDQuality by Design质量源于设计QC Quality Control质量控制OFDOperation Flow Diagram操作流程图OOSOut of Specification 超标OOTOut of Trend超出正常趋势OQOperational Qualification 运行确认PPATProces

10、s Analytical Technology过程分析技术PCSProcess Control System 工艺控制系统PIC/SPharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme药品检查公约/药品检查合作计划PID Piping and Instruments Diagram管路及仪表布置图PLCProgrammable Logic Controller 可编程逻辑控制器PMDProcess Module Diagram工艺模块图POUPoint of Use使用点PQPerfo

11、rmance Qualification 性能确认PQRProduct Quality Review产品质量回顾PWPurified Water 纯化水PSPure Steam 纯蒸汽PVProcess Validation工艺验证QQMQuality Management 质量管理QMSQuality Management System质量管理体系RRABSRestricted Access Barrier System限制进入隔离系统RTMRequirements Traceability Matrix需求追溯矩阵SSATSite Acceptance Test 现场验收测试SCADASu

12、pervisory Control and Data Acquisition System 数据采集与监控系统SIA System Impact Assessment系统影响评估SIP Sterilize In Place (Steam In Place)在线灭菌SMF Site Master File工厂主文件SOPStandard Operational Procedure 标准操作规程TTOCTotal Organic Carbon 总有机碳UUDFUnidirectional Flow单向流URS User Requirement Specification用户需求说明USP US Pharmacopoeia美国药典VVMP Validation Master Plan验证主计划VP Validation Protocol验证方案VRValidation Report验证报告WWFI Water for Injection注射用水【精品文档】第 4 页