制藥行業(yè)術(shù)語及藥政、行業(yè)組織簡稱

1、序號英文縮寫英文全稱中文全稱首字母A1ACAirConditioner空調(diào)2ADRAdverseDrugReaction藥品不良的反應(yīng)3AHUAirHandlingUnit空氣處理單元4APIActivePharmaceuticalIngredient活性藥物組分（原料藥）5ASTMAmericanSocietyforTestingandMaterials(International)美國材料與試驗協(xié)會（國際）6APICActivePharmaceuticalIngredientsCommittee歐洲原料藥協(xié)會首字母B1BOMBillofMaterial物料清單2BPBritishPharm

2、acopeia英國藥典3BRBatchRecord批記錄首字母C1CCAComponentCriticalityAssessment部件關(guān)鍵性評估2CAPACorrectiveandPreventiveAction糾正預(yù)防措施3CFUColonyFormingUnit菌落形成單位4cGMPCurrentGoodManufacturingPractice現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范5CIPCleaningInPlace在線清洗6CNCControlledNotClassified控制未分類7COACertificateofAnalysis分析報告單8COPCleaningOutofPlace離線清洗

3、9CPPCriticalProcessParameters關(guān)鍵工藝參數(shù)10CQACriticalQualityAttributes關(guān)鍵的特性11CROContractResearchOrganization合同研究組織（外包）12CSComputerizedSystem計算機化系統(tǒng)13CTDCommonTechnicalDocument通用技術(shù)文件14CVCleaningValidation清潔驗證15CMCChemistryManufacturingControl化學(xué)制造控制16CDCCentersforDiseaseControlandPrevention疾病預(yù)防與控制中心17CEPCer

4、tificateofSuitabilityforEuropeanPharmacopeia歐洲藥典適用性證書18ChPPharmacopoeiaofthePeoplesRepublicofChina中國藥典委員會19CDECenterForDrugEvaluation中國藥品審評中心20CFDICenterForFoodAndDrugInspectionOfNMPA中國藥品審核查驗中心21CDRChinaAdverseDrugReactionMonitoringCenter中國藥品不良反應(yīng)監(jiān)測中心序號英文縮寫英文全稱中文全稱首字母D1DMFDrugMasterFile藥物主文件2DPDiffer

5、entialPressure壓差3DQDesignQualification設(shè)計確認(rèn)4DSDesignSpecification設(shè)計說明5DRDesignReview設(shè)計評審6DSCDistributedControlSystem集散控制系統(tǒng)首字母E1EDIElectro-de-ionization電去離子2EHSEnvironment,HealthandSafety環(huán)境，健康和安全3EU-GMPEuropeanGoodManufacturingPractice歐洲GMP4EPEuropeanPharmacopoeia歐洲藥典5EDQMEuropeanDirectoratefortheQual

6、ityofMedicines歐洲藥品質(zhì)量管理局6EMAEuropeanMedicinesAgency歐洲藥品管理局7EUEuropeanUnion歐盟首字母F1FATFactoryAcceptanceTest出廠驗收測試2FMEAFailureModeEffectsAnalysis失效模式與影響分析3FMECAFailureMode,EffectsandCriticalityAnalysis失效模式影響分析（FMEA）和危害性分析（CA）4FSFunctionalSpecification功能說明5FDAFoodandDrugAdministration(US)美國食品藥品監(jiān)督管理局首字母G1

7、GAMPGoodAutomatedManufacturingPractice優(yōu)良自動化生產(chǎn)管理規(guī)范2GCGasChromatography氣相色譜3GCPGoodClinicalPractice藥品臨床研究管理規(guī)范4GEPGoodEngineeringPractice優(yōu)良工程管理規(guī)范5GLPGoodLaboratoryPractice藥品非臨床研究質(zhì)量管理規(guī)范6GMPGoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范7GSPGoodSupplyPractice藥品經(jīng)營質(zhì)量管理規(guī)范首字母H1HACCPHazardAnalysisandCriticalControlPoint危

8、害分析和關(guān)鍵環(huán)節(jié)控制點序號英文縮寫英文全稱中文全稱2HAZOPHazardandOperabilityAnalysis危害與可操作性分析3HEPAHighEfficiencyParticulateAir高效空氣過濾器4HMIHumanMachineInterface人機界面5HPLCHighPerformanceLiquidChromatography高效液相色譜6HVACHeatingVentilationandAirConditioning暖通空調(diào)系統(tǒng)首字母I1IAImpactAssessment影響評估2INDInvestigationalNewDrug臨床研究申請3INNInterna

9、tionalNon-proprietaryName國家非專利名4IPCIn-processControls過程控制5IQInstallationQualification安裝確認(rèn)6IRInfraredSpectrophotometer紅外分光光度計7ISOInternationalStandardOrganization國際標(biāo)準(zhǔn)化組織8ISPEInternationalSocietyforPharmaceuticalEngineering國際制藥工程協(xié)會9ICHInternationalConferenceonHarmonizationofTechnicalRequirementsforReg

10、istrationofPharmaceuticalsforHumanUse人用藥品注冊技術(shù)要求國際協(xié)調(diào)會首字母J1JPJapanesePharmacopoeia日本藥典首字母L1LAFLaminarAirFlow單向流2LELLowerExplosionLimit爆炸下限3LEVLocalExhaustVentilation局部排風(fēng)4LODLimitofDetection檢測限5LOQLimitofQuantitation定量限首字母M1MAMarketingAuthorization上市許可2MAAMarketingAuthorizationApplication上市申請3MBRMaster

11、BatchRecord主批生產(chǎn)記錄4MOAMethodOfAnalysis分析方法5MSDSMaterialSafetyDataSheet化學(xué)品安全技術(shù)說明書6MHRAMedicinesAndHealthcareProductsRegulatoryAgency英哂品管理局首字母N序號英文縮寫英文全稱中文全稱1NDANewDrugApplication新藥申請2NFNationalFormulary美國國家藥品集3NIFDCNationalInstitutesforFoodandDrugControl中國食品藥品檢定研究院4NMPANationalMedicalProductsAdministr

12、ation中國藥品監(jiān)督管理局首字母O1OOSOutofSpecification超標(biāo)2OOTOutofTrend超出正常趨勢3OQOperationQualification運行確認(rèn)4OSDOralSolidDosage口服固體制劑5OTCOver-the-counter非處方6OSHAOccupationalSafetyandHealthAdministration(US)職業(yè)安全與健康署（美國）首字母P1P&IDPipingandInstrumentsDiagram管路及儀表布置圖2PATProcessAnalyticalTechnology過程分析技術(shù)3PDCAPlan,Do,Check

13、,Action計劃、執(zhí)行、檢查、處理4PFDSProcessFlowDiagrams工藝流程圖5PHAPreliminaryHazardAnalysis初步危害分析6PIPackageInsert說明書7PLCProgrammableLogicController可編輯邏輯控制器8PMPreventiveMaintenance預(yù)防性維修9PPEPersonalProtectiveEquipment個人防護設(shè)備10PPMPartsPerMillion每百萬分之一11PQPerformanceQualification性能確認(rèn)12PQRProductQualityReview產(chǎn)品質(zhì)量回顧13PSP

14、ureSteam純蒸汽14PVProcessValidation工藝驗證15PVPProjectValidationPlan項目驗證計劃16PVRProjectValidationReport項目驗證報告17PWPurifiedWater純化水18PDAParenteralDrugAssociation國際注射劑協(xié)會19PIC/SPharmaceuticalInspectionConvention/PharmaceuticalInspectionCo-operationScheme國際醫(yī)藥品檢查組織首字母Q序號英文縮寫英文全稱中文全稱1QAQualityAssurance質(zhì)量保證2QbDQua

15、litybyDesign質(zhì)量源于設(shè)計3QCQualityControl質(zhì)量控制4QMSQualityManagementSystem質(zhì)量管理體系5QRMQualityRiskManagement質(zhì)量風(fēng)險管理首字母R1RARiskAnalysis風(fēng)險分析2RHRelativeHumidity相對濕度3ROReverseOsmosis反滲透首字母S1SATSiteAcceptanceTest現(xiàn)場驗收測試2SIInternationalSystemofUnit國際單位制3SIASystemImpactAssessment系統(tǒng)影響評估4SIPSterilizeInPlace(SteamInPlace)

16、在線滅菌5SMStartingMaterial起始物料6SMFSiteMasterFile工廠主文件7SMPStandardManagementProcedure標(biāo)準(zhǔn)管理程序8SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程首字母T1TLCThin-LayerChromatography薄層色譜2TOCTotalOrganicCarbon總有機碳3TSTechnicalSpecification技術(shù)標(biāo)準(zhǔn)文件首字母U1UDFUnidirectionalFlow單向流2ULPAUntraLowPenetrationAir超高效空氣過濾器3UPSUninterruptedPowerSupply不間斷電源4URSUserRequirementSpecification用戶需求說