制药工艺验证实施手册缩略语

'术语/缩略语英文全拼中文AHUAirHandingUnit空调机组AOACAssociationofOfficialAnalyticalChemists美国公职化学家协会AMVAnalyticalMethodValidation分析方法验证APIActivePharmaceuticalIngredient药物活性成分ASMEAmericanSocietyofMechanicalEngineers美国机械工程学会ASMEBPEAmericanSocietyofMechanicalEngineersBioprocessingEquipment美国机械工程/生物工程设备学会ASTMAmericanSocietyforTestingandMaterials美国材料与试验协会BDBowie-Dick布维-狄克BIBiologicalindicator生物指示剂BMSBuildingManagementSystem楼宇控制系统CAPACorrectiveandPreventativeAction纠正和预防措施CCAComponentCriticalityAssessment部件关键性评估CCPCriticalControlPoint关键控制点CDCycleDevelopment程序开发CEHTCleanequipmentholdtime干净设备保留时间CFRCodeForFederalRegulations美国联邦法规CFUColonyFormingUnit菌落形成单位cGMPCurrentGoodManufacturingPractice现行药品生产质量管理规范CHOChineseHamsterOvary中国仓鼠卵巢细胞 CIPCleanInPlace在线清洗ChPChinesePharmacopeia中国药典Cp/CpkProcessCapabilityIndex工序能力指数CPPCriticalProcessParameter关键工艺参数CQACriticalQualityAttribute关键质量属性CSVComputerSystemValidation计算机系统验证CVPCleaningValidationPlan清洁验证计划DCSDistributedControlSystem分布式控制系统DDSDetailedDesignSpecification详细设计说明DEHTDirtyequipmentholdtime脏设备保留时间DNADeoxyribonucleicacid脱氧核糖核酸DOEDesignofExperiment实验设计DOPDioctylPhthalate（OrEquivalent，I.E.,DispersedOilParticulate）邻苯二甲酸二辛脂（或等同品，例如分散油颗粒）DQDesignQualification设计确认DSDesignSpecification设计说明ED5050%EffectiveDose半数有效量EDIElectrodeionizationDeionization(USFilter)电级法去离子（美国滤材）EHSEnvironmentHealthSafety环境健康安全ELISAEnzyme-LinkedImmunoSorbentAssay酶联免疫吸附测定EMAEuropeanMedicinesAgenc欧洲药品管理局 EMSEnvironmentalMonitoringSystem环境监测系统EPEuropeanPharmacopoeia欧洲药典EPAEnvironmentalProtectionAgency美国环境保护署ERPEnterpriseResourcePlanning企业资源计划ETOPEngineeringturnoverpackages工程交付包EUEuropeanUnion欧盟FATFactoryAcceptanceTesting工厂验收测试FDAFoodandDrugAdministration美国食品与药品监督管理局FDSFunctionalDesignSpecification功能设计说明FMEAFailureModesAndEffectsAnalysis失效模式和影响分析FSFunctionSpecification功能说明FTAFaultTreeAnalysis故障树分析FQCPFieldQualityControlPlan现场质量控制计划GAMPGoodAutomatedManufacturingPractice良好自动化生产实践GDPGoodDocumentPractice良好文件管理规范GEPGoodEngineeringPractice良好工程管理规范GLPGoodLaboratoryPractice良好实验室管理规范GMPGoodManufacturingPractice良好药品生产管理规范GxPGoodxPractice药品质量管理规范HACCPHazardAnalysisandCriticalControlPoints危害分析和关键控制点 HAZOPHazardandOperabilityAnalysis危险与可操作性分析HDSHardwareDesignSpecification硬件设计说明HEPAHighEfficiencyParticulateAir高效空气过滤器HBVHepatitisBVirus乙型肝炎病毒HIVHumanImmunodeficiencyVirus人类免疫缺陷病毒HMIHumanMachineInterface人机界面HPLCHighPerformanceLiquidChromatography高效液相色谱HVACHeating,Ventilation,AndAirConditioning采暖通风和空调系统I/OInputandOutput输入/输出IC50TheHalfmaximalinhibitoryconcentration半抑制浓度ICHInternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse人用药品注册技术要求国际协调会IECInternationalElectrotechnicalCommission国际电工委员会IQInstallationQualification安装确认ISOInternationalStandardsOrganization国际标准化组织ISPETheInternationalSocietyforPharmaceuticalEngineering国际制药工程协会IUPACInternationalUnionofPureandAppliedChemistry国际理论（化学）与应用化学联合会LIMSLaboratoryInformationManagementSystem实验室信息管理系统LODLimitsofDetection检测限度LOQLimitofQuantizatity含量限度 MB/LMethyleneblue亚甲蓝光敏法MCBMasterCellBank主细胞库MESManufacturingExecutionSystem生产执行系统MTDDminimumtreatmentdailydosage最低日治疗剂量OOSOutofSpecification检验结果偏差OQOperationalQualification运行确认OSDOralSolidDosage口服固体制剂P&IDPipingandInstrumentationDiagrams管道和仪表图PAOPoly-Alpha-Olefin聚Α-烯烃PATProcessAnalyticalTechnology过程分析技术PBSphosphatebuffer磷酸缓冲液PCBPrimaryCellBank原始细胞库PCRPolymeraseChainReaction聚合酶链反应PDAParenteralDrugAssociation美国注射剂协会PDIPre-deliveryInspection发货前检查PEPProjectExecutionPlan项目执行计划PFDProcessFlowDiagrams工艺流程图PHAPreliminaryHazardAnalysis初步危害分析PIC/SPharmaceuticalInspirationConventionAndPharmaceuticalInspectionCo-OperationScheme国际药品检查协会组织PLCProgrammableLogicController可编程逻辑控制器 PMProjectManagemnet项目管理PPPolypropylene聚丙烯PPEPersonalProtectiveEquipment人员保护装备PPQProcessPerformanceQualification工艺性能确认PQPerformanceQualification性能确认PSPureSteam纯蒸汽PTFEPolytetrafluoroethylene聚四氟乙烯PVProcessValidation工艺验证PVCPolyvinylChloride聚氯乙烯PVPProcessValidationPlan工艺验证计划PWPurifiedWater纯化水QAQualityAssurance质量保证QbDQualitybyDesign质量源于设计QCQualityControl质量控制QMSQualityManagementSystem质量管理体系QPPQualityandProjectPlan质量及项目计划QRMQualityRiskManagement质量风险管理RARiskAssessment风险分析RABSRestrictedAccessBarrierSystem限制进出隔离系统RHRelativeHumidity相对湿度 RNARibonucleicAcid核糖核酸ROReverseOsmosis反渗透RPNRiskPriorityNumber风险优先性RSDRelativeStandardDeviation相对标准偏差RTMRequirementsTraceabilityMatrix需求追溯性矩阵RTPRapidTransferPort快速运转接口SALSterilityAssuranceLevel灭菌保证水平SATSiteAcceptanceTesting现场验收测试SCADASupervisoryControlAndDataAcquisition检测控制和数据收集SCRSourceCodeReview源代码审核SDA-PAGESodiumDodecylSulfate-polyacrylamidegel十二烷基硫酸钠-聚丙烯酰胺凝胶SDISiltDensityIndex淤泥指数SDSSoftwareDesignSpecification软件设计说明SFDAStateFoodandDrugAdministration国家食品药品监督管理局SIASystemImpactAssessment系统影响性评估SIPSterilizeInPlace在线灭菌SMESubjectMatterExpert主题专家SMSSoftwareModuleSpecifications软件模块说明SMTSoftwareModuleTest软件模块测试SOPStandardOperatingProcedure标准操作规程 SVSindbisVirus辛德毕斯病毒TMTraceabilityMatrix可追溯矩阵TOCTotalOrganicCarbon总有机碳TRTechnicalReport技术报告UAFUnidirectionalAirflow单向气流UCLUpperconfidencelimit置信上限UPSUninterruptablePowerSupply不间断电源URBUserRequirementsBrief用户需求简介URSUserRequirementsSpecification用户需求说明USPUnitedStatesPharmacopoeia美国药典UVUltravioletLight紫外灯VHPVaporizedHydrogenPeroxide汽化过氧化氢灭菌技术VMPValidationMasterPlan验证主计划/验证总计划VPValidationPlan验证计划VSRValidationSummaryReport验证总结报告VSVVesicularStomatitisVirus水疱性口炎病毒WCBWorkingCellBank工作细胞库WFIWaterforInjection注射用水WHOWorldHealthOrganization世界卫生组织WIPWettingInPlace在线加湿'