制药英文缩写词表

常见词汇缩写英文缩写英文全称中文AACAirConditioner空调ADRAdverseDrugReaction药品不良反应AHUAirHandlingUnit空气处理单元APIActivePharmaceuticalIngredient活性药物组分（原料药）ANDAAbbreviatedNewDrugApplication简略新药申请AQLAcceptableQualityLevel可接受质量水平ASMActiveSubstanceManufacturer活性物质生产商ASMEAmericanSocietyofMechanicalEngineers美国机械工程师协会BBMSBuildingMonitoringSystem楼宇监测系统BOMBillofMaterial物料清单BPBritishPharmacopoeia英国药典BPCBulkpharmaceuticalChemicals原料药CCAPACorrectiveandPreventiveAction纠正预防措施CCAComponentCriticalityAssessment组件关键性评估CEPCertificateofSuitabilityforEuropeanPharmacopeia欧洲药典适用性证书CFRCodeofFederalRegulations美国联邦法规CFUColonyFormingUnit菌落形成单位CHWChilledWater冷冻水CIPCleaninPlace在线清洗CIPCCriticalIn-ProcessControl关键中间控制点CNCControlledNon-Classified控制但未分级COACertificateofAnalysis分析报告单COMCommissioning试车COPCleanoutofPlace离线清洗CPPCriticalProcessParameter关键工艺参数CQACriticalQualityAttribute关键质量属性CROContractResearchOrganization合同研究组织（外包）CSComputerizedSystem计算机系统CTDCommonTechnicalDocument通用技术文件CVCleaningValidation清洁验证CMCChemistryManufacturingControl化学制造控制DDMFDrugMasterFile药物主文件DSDesignSpecification设计说明EEDQMEuropeanDirectoratefortheQualityofMedicines&HealthCare欧洲药品与健康质量理事会EHSEnvironment,HealthandSafety环境、健康和安全EMAEuropeanMedicinesAgency欧洲药监局EPEuropeanPharmacopoeia欧洲药典FFATFactoryAcceptanceTest出厂验收测试FDAFOODANDDRUGADMINISTRATION（美国）食品药品监督管理局FDSFunctionDesignSpecification功能设计说明FEMAFailureModeandEffectsAnalysis失效模式及后果分析FFUFanFilterUnit风机过滤单元FMSFacilityMonitoringSystem设施监控系统FSFunctionalSpecification功能说明GGAMPGoodAutomatedManufacturingPractice优良自动化生产管理规范GCPGoodClinicalPractice药品临床研究管理规范GEPGoodEngineeringPractice优良工程管理规范GLPGoodLaboratoryPractice药品临床前安全性研究质量管理规范GMPGoodManufacturingPractice药品生产质量管理规范GSPGoodSupplyPractice药品经营质量管理规范HHACCPHazardAnalysisandCriticalControlPoint危害分析和关键环节控制点HEPAHighEfficiencyParticulateAir高效空气过滤器HMIHumanMachineInterface人机界面HVACHeatingVentilationAirConditioning供热、通风与空调系统IICHInternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse人用药品注册技术要求国际协调会INDINVESTIGATIONALNEWDRUG临床研究申请INNInternationalNon-proprietaryName国际非专利名IQInstallationQualification安装确认ISPEInternationalSocietyforPharmaceuticalEngineering国际制药工程协会LLIMSLaboratoryInformationManagementSystem实验室信息管理系统MMAMarketingAuthorisation上市许可MAAMarketingAuthorisationApplication上市申请MBRMasterBatchRecord主生产批记录NNDANEWDRUGAPPLICATION新药申请OQAQualityAssurance质量保证QbDQualitybyDesign质量源于设计QCQualityControl质量控制OFDOperationFlowDiagram操作流程图OOSOutofSpecification超标OOTOutofTrend超出正常趋势OQOperationalQualification运行确认PPATProcessAnalyticalTechnology过程分析技术PCSProcessControlSystem工艺控制系统PIC/SPharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme药品检查公约/药品检查合作计划PIDPipingandInstrumentsDiagram管路及仪表布置图PLCProgrammableLogicController可编程逻辑控制器PMDProcessModuleDiagram工艺模块图POUPointofUse使用点PQPerformanceQualification性能确认PQRProductQualityReview产品质量回顾PWPurifiedWater纯化水PSPureSteam纯蒸汽PVProcessValidation工艺验证QQMQualityManagement质量管理QMSQualityManagementSystem质量管理体系RRABSRestrictedAccessBarrierSystem限制进入隔离系统RTMRequirementsTraceabilityMatrix需求追溯矩阵SSATSiteAcceptanceTest现场验收测试SCADASupervisoryControlandDataAcquisitionSystem数据采集与监控系统SIASystemImpactAssessment系统影响评估SIPSterilizeInPlace(SteamInPlace)在线灭菌SMFSiteMasterFile工厂主文件SOPStandardOperationalProcedure标准操作规程TTOCTotalOrganicCarbon总有机碳UUDFUnidirectionalFlow单向流URSUserRequirementSpecification用户需求说明USPUSPharmacopoeia美国药典VVMPValidationMasterPlan验证主计划VPValidationProtocol验证方案VRValidationReport验证报告WWFIWaterforInjection注射用水