制藥英文縮寫

制藥常見英文縮寫,,

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英文縮寫,英文全程,中文

A,,

AC,AirConditioner,空調(diào)

ADR,AdverseDrugReaction,藥品不良的反應(yīng)

AHU,AirHandlingUnit,空氣處理單元

API,ActivePharmaceuticalIngredient,活性藥物組分(原料藥）

ANDA,AbbreviatedNewDrugApplication,簡略新藥申請

AQL,AcceptableQualityLevel,可接受質(zhì)量水平

ASM,ActiveSubstanceManufacture,活性物質(zhì)生產(chǎn)商

ASME,AmericanSocietyofMechanicalEngineers,美國機(jī)械工程師協(xié)會

B,,

BMS,BuildingMonitoringSystem,樓宇檢測系統(tǒng)

BOM,BillofMaterial,物料清單

BP,BritishPharmacopoeia,英國藥典

BPC,BulkpharmaceuticalChemicals,原料藥

C,,

CAPA,CorrectiveandPreventiveAction,糾正預(yù)防措施

CCA,ComponentCriticalityAssessment,組件關(guān)鍵性的評估

CEP,CertificateofSuitabilityforEuropeanPharmacopeia,歐洲藥典適用性證書

CFR,CodeofFederalRegulations,美國聯(lián)邦法規(guī)

CFU,ColonyFormingUnit,菌落形成單位

CHW,ChilledWater,冷凍水

CIP,CleaninPlace,在線清洗

CIPC,CriticalIn-ProcessControl,關(guān)鍵中間控制點(diǎn)

CNC,ControlledNon-Classified,控制但未分級

COA,CertificateofAnalysis,分析報告單

COM,Commissioning,試車

COP,CleanoutofPlace,離線清洗

CPP,CriticalProcessParameter,關(guān)鍵工藝參數(shù)

CQA,CriticalQualityAttribute,關(guān)鍵質(zhì)量屬性

CRO,ContractResearchOrganization,合同研究組織（外包）

CS,ComputerizedSystem,計算機(jī)系統(tǒng)

CTD,CommonTechnicalDocument,通用技術(shù)文件

CV,CleaningValidation,清潔驗(yàn)證

CMC,ChenistryManufacturingControl,化學(xué)制造控制

CGMP,CurrentGoodManufacturingPractice,

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D,,

DMF,DrugMasterFile,藥物主文件

DS,DesignSpecification,設(shè)計說明

DCC,DocumentControlCoordinator,文件控制協(xié)調(diào)者

DQ,DesignQualification,設(shè)計確認(rèn)

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E,,

EC,EuropeanCommission,歐洲委員會

EQDM,EuropeanDirectoratefortheQualityofMedicines&HealthCare,歐洲藥品與健康質(zhì)量理事會

EHS,"Envieonment,HealthandSafety",環(huán)境，健康和安全

EMA,EuropeanMedicinesAgency,歐洲藥監(jiān)局

EP,EuropeanPharmacopoeia,歐洲藥典

EDR,EnhancedDesignReview,增加的設(shè)計審核

EDQM,EuropeandirectoratefortheQualityofMedicines,歐洲藥品理事會

EMEA,Europeanagencyfortheevaluationofmedicinalproduct,歐洲藥品評價局

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F,,

FAT,FactoryAcceptanceTest,出廠驗(yàn)收測試

FDA,FOODANDDRUGADMINISTRATION,(美國）食品藥品監(jiān)督管理局

FDS,FunctionDesgnSpeciation,功能設(shè)計說明

FEMA,FaliureModeandEffectsAnalysis,失效模式及后果分析

FFU,FanFilterUnit,風(fēng)機(jī)過濾單元

FMS,FactoryMonitoringSystem,設(shè)施監(jiān)控系統(tǒng)

FS,FunctionalSpecifiaction,功能說明

G,,

GAMP,GoodAutomatedManufacturingPractice,優(yōu)良自動化生產(chǎn)管理規(guī)范

GCP,GoodClinicalPractice,藥品臨床研究管理規(guī)范

GEP,GoodEngineeringPractice,優(yōu)良工程管理規(guī)范

GLP,GoodLaboratoryPractice,藥品臨床前安全性研究質(zhì)量管理規(guī)范

GMP,GoodManufacturingPratice,藥品生產(chǎn)質(zhì)量管理規(guī)范

GSP,GoodSupplyPratice,藥品經(jīng)營質(zhì)量管理規(guī)范

H,,

HACCP,HazardAnalysisandCriticalControlPoint,危害分析和關(guān)鍵環(huán)節(jié)控制點(diǎn)

HEPA,HighEfficiencyParticulateAir,高效空氣過濾器

HMI,HumanMachineInterface,人機(jī)界面

HVAC,HeatingVentilationAirConditioning,供熱，通風(fēng)，空調(diào)系統(tǒng)

HCI,Human-ComputerInterface,人機(jī)界面或用戶界面或使用者界面

I,,

ICH,InternationalConferenceonHarmonisationofTechnicalRequirementsforRegisterationofPharmaceuticalsforHumanUse,人用藥品注冊技術(shù)要求國際協(xié)調(diào)會

IND,INVERSTIGATIONALNEWDRUG,臨床研究申請

INN,InternationalNon-proprietaryName,國家非專利名

IQ,InstallationQualification,安裝確認(rèn)

ISPE,InternationalSocietyforPharmaceuticalEngineering,國際制藥工程協(xié)會

IA,ImpactAssessment,影響評估

IOQ,InstallationandOperationalQualification,安裝和運(yùn)行確認(rèn)

IPC,InProcessControl,過程控制

L,,

LIMS,LaboratoryInformationManagementSystem,實(shí)驗(yàn)室信息管理系統(tǒng)

LAF,LaminarAirFlow,單向流

LOD,Limitofdetection,檢測限

LOQ,LimitofQualificatioon,定量限

M,,

MA,MarketingAuthorisation,上市許可

MAA,MarketingAuthorisationApplication,上市申請

MBR,MasterBatchRecord,主生產(chǎn)批記錄

N,,

NDA,NEWDRUGAPPLICATION,新藥申請

o,,

OFD,OperationFlowDiagram,操作流程圖

OOS,OutofSpecification,超標(biāo)

OOT,OutofTrend,超出正常趨勢

OQ,OperationalQualification,運(yùn)行確認(rèn)

P,,

PAT,ProcessAnalyticalTechnology,過程分析技術(shù)

PCS,ProcessControlSystem,工藝控制系統(tǒng)

PICS/S,PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,藥品檢查公約/藥品檢查合作計劃

PID,PipingandInstrumentsDiagram,管路及儀表布置圖

PLC,ProgrammableLogicController,可編輯邏輯控制器

PMD,ProcessModuleDiagram,工藝模塊圖

POU,PointofUse,使用點(diǎn)

PQ,PerformaceQualification,性能確認(rèn)

PQR,ProductQualityReview,產(chǎn)品質(zhì)量回顧

PW,PurifiedWater,純化水

PS,PureSteam,純蒸汽

PPM,PartsPerMillion,每百萬分之一

PV,ProcessValidation,工藝驗(yàn)證

PVP,ProjectValidationPlan,項(xiàng)目驗(yàn)證計劃

PVR,ProjectValidationReport,項(xiàng)目驗(yàn)證報告

Q,,

Q7,,優(yōu)良制造規(guī)范指南

Q7a,,原料藥的優(yōu)良制造規(guī)范指南

QA,QualityAssurance,質(zhì)量保證

QbD,QualitybyDesign,質(zhì)量源于設(shè)計

QC,QualityControl,質(zhì)量控制

QM,QualityManagement,質(zhì)量管理

QMS,QualityManagementSystem,質(zhì)量管理體系

R,,

RABS,RestrictedAccessBarrierSystem,限制進(jìn)入隔離系統(tǒng)

RTM,RequirementsTraceabilityMatrix,需求追溯矩陣

R&D,ResearchandDevelopment,研發(fā)

RA,RiskAnalysis,風(fēng)險分析

S,,

SAT,SiteAcceptanceTest,現(xiàn)場驗(yàn)收測試

SCADA,SupervisoryControlandDataAcquisitionSystem,數(shù)據(jù)采集與監(jiān)控系統(tǒng)

SIA,SystemImpactAssessment,系統(tǒng)影響評估

SIP,SterilizeInPlace(SteamInPlace),在線滅菌

SMF,SiteMasterFile,工廠主文件

SOP,StandardOperationalProcedure,標(biāo)準(zhǔn)操作規(guī)程

T,,

TOC,TotalOrganicCarbon,總有機(jī)碳

U,,

UDF,Unidirectiona