GMP應(yīng)用英語(yǔ)培訓(xùn)

GMP相關(guān)英語(yǔ)分享者：質(zhì)量部李杰一、相關(guān)法規(guī)GMP：GoodManufacturePractice藥品生產(chǎn)質(zhì)量管理規(guī)范FDA：FoodandDrugAdministration美國(guó)食品藥品監(jiān)督管理局WHO:WorldHealthOrganization世界衛(wèi)生組織ICH:InternationalConferenceonHarmonization國(guó)際協(xié)調(diào)會(huì)議（研發(fā)注冊(cè)）SDA:StateDrugAdministration國(guó)家藥品監(jiān)督管理局ISO:InternationalOrganizationforStandardization國(guó)際標(biāo)準(zhǔn)化組織IPEC:InternationalPharmaceuticalExcipientsCouncil國(guó)際制藥工程協(xié)會(huì)EMEA:TheEuropeanAgencyfortheEvaluationofMedicinalProducts歐洲共同體藥物評(píng)審委員會(huì)PIC/S：PharmaceuticalInspectionConventionandPharmaceuticalInspectionCo-operationScheme國(guó)際藥品認(rèn)證合作組織

ISPE:InternationalSocietyForPharmaceuticalEngineering國(guó)際制藥工程協(xié)會(huì)GSP：GoodSupplyPractice藥品銷售管理規(guī)范GLP：GoodLaboratoryPracticeofDrug藥品非臨床研究質(zhì)量管理規(guī)范GCP：GoodClinicalPractice藥物臨床試驗(yàn)管理規(guī)范二、管理文件中涉及到的英文QM:QualityManagement質(zhì)量管理QA:QualityAssurance質(zhì)量保證QC:QualityControl質(zhì)量控制OBL:Obligation職責(zé)RD:ResponsibilitiesofDepartments部門(mén)職責(zé)JR:JobResponsibilities崗位職責(zé)STP:StandardTechnologyProcedure技術(shù)標(biāo)準(zhǔn)TR:TechnicalRegulations工藝規(guī)程QS:QualityStandard質(zhì)量標(biāo)準(zhǔn)SMP:StandardManagementProcedure管理規(guī)程IM:InstitutionsandPersonnelManagement機(jī)構(gòu)與人員管理BM:BuildingsandFacilitiesManagement廠房與設(shè)施管理DM:DeviceManagement設(shè)備管理MM:MaterialManagement物料管理SC:SanitaryControl衛(wèi)生管理VM:VerificationManagement驗(yàn)證管理FM:FileManagement文件管理PC:ProductionControl生產(chǎn)管理PM:ProductSellingandRecoveryManagement產(chǎn)品銷售與收回管理CM:ComplaintsandadversereactionManagement投訴與不良反應(yīng)管理SM:SelfManagement自檢管理SOP:StandardOperationProcedure操作規(guī)程PO:ProductionandOperation生產(chǎn)操作CO:CleaningOperation設(shè)備清潔操作SO:SanitaryOperation衛(wèi)生操作EO:EquipmentOperation設(shè)備操作TO:TestOperation檢驗(yàn)操作MO:MaterialsmanagementOperation物料管理操作QO:QualitymanagementOperation質(zhì)量管理操作三、驗(yàn)證文件中涉及到的英文VMP:ValidationMasterPlan驗(yàn)證總計(jì)劃PVMP:ProjectValidationMasterPlan驗(yàn)證項(xiàng)目總計(jì)劃AVP:AnnualValidationPlan年度驗(yàn)證計(jì)劃VP:ValidationProtocol驗(yàn)證方案VR:ValidationReport驗(yàn)證報(bào)告BF:BuildingsandFacilities廠房設(shè)施EI:EquipmentandInstrument設(shè)備儀器DD:DisinfectioneffectofDisinfectant消毒劑消毒效果EC:EquipmentCleaning設(shè)備清潔MC:MethodofCalibration校驗(yàn)方法URS:UserRequirementSpecification用戶需求標(biāo)準(zhǔn)FS:FunctionalSpecification功能標(biāo)準(zhǔn)FAT:FactoryAcceptanceTesting工廠（生產(chǎn)地）接受測(cè)試SAT:SiteAcceptanceTesting

安裝地接受測(cè)試DS:DesignSpecification設(shè)計(jì)標(biāo)準(zhǔn)DQ:DesignQualification設(shè)計(jì)確認(rèn)IQ:InstallationQualification安裝確認(rèn)OQ:OperationalQualification運(yùn)行確認(rèn)PQ:PerformanceQualification性能確認(rèn)SIA:SystemImpactAssessment系統(tǒng)影響性評(píng)估CCA:ComponentCriticalityAssessment部件關(guān)鍵性評(píng)估OOS:OutOfSpecification檢驗(yàn)結(jié)果偏差OOT:Out-of-Trend超趨勢(shì)RSD:RelativeStandardDeviation相對(duì)標(biāo)準(zhǔn)偏差FMEA:FailureModeandEffectsAnalysis失敗模式和影響分析FTA:FaultTreeAnalysis故障樹(shù)分析CAPA:CorrectiveActionandPreventiveAction糾正預(yù)防措施HACCP:HazardAnalysisandCriticalControlPoint

危害分析及關(guān)鍵控制點(diǎn)QRM:QualityRiskManagement質(zhì)量風(fēng)險(xiǎn)管理RP:RiskProtocol風(fēng)險(xiǎn)評(píng)估方案RR:RiskReport風(fēng)險(xiǎn)評(píng)估報(bào)告四、其他相關(guān)英文SR:SupplierForm供應(yīng)商表格（供應(yīng)商分級(jí)對(duì)照表）AR:AuditReport審計(jì)報(bào)告SL:SupplierList供應(yīng)商清單BillofMaterials物料清單CCD:CertificationCommitteeforDrugs藥品認(rèn)證管理中心CDER:CenterforDrugEvaluationandResearch藥品研究與評(píng)價(jià)中心CDC:CentersforDiseaseControlandPrevention疾病預(yù)防控制中心ADR:AdverseDrugReaction藥物不良反應(yīng)ADE:AdverseDrugEvent藥品不良事件DMF:DrugMasterFile藥物管理檔案（藥物主文件）CQA:CriticalQualityAttributes關(guān)鍵質(zhì)量特性APR:AnnualProductReview年度質(zhì)量回顧MSDS:MaterialSafetyDataSheet物料安全數(shù)據(jù)說(shuō)明書(shū)DS:DocumentationSystem文件系統(tǒng)QualifiedPerson質(zhì)量授權(quán)人Qualitysystem質(zhì)量系統(tǒng)CTD:CommonTechnicalDocument通用技術(shù)文件USA:UnitedStatesPharmacopeia美國(guó)藥典API:ActivePharmaceuticalIngredient活性藥用成分COA:CertificateOfAnalysis分析報(bào)告單HPLC:HighPerformanceLiquidChromatography高效液相色譜UV:Ultraviolet紫外TLC:ThinLayerChromatography薄層色譜TOC:TotalOrganicCarbon總有機(jī)碳量CFU:Colony-FormingUnits單位體積中的活菌個(gè)數(shù)

GC:GasChromatography氣相色譜IR:Infrared紅外ConfigurationSpecification:配制標(biāo)準(zhǔn)OTCdrug:Over-the-counterdrug非處方藥prescriptiondrug:處方藥Repetitionoftheanalysis:重新檢驗(yàn)Repetitionoftheinjection:重新進(jìn)樣Resampling:重新取樣Riskidentification風(fēng)險(xiǎn)識(shí)別Definetheriskquestion確定風(fēng)險(xiǎn)評(píng)估的問(wèn)題Collectandorganiseinformation收集組織信息Riskanalysis風(fēng)險(xiǎn)分析Chooseriskassessmenttool選擇風(fēng)險(xiǎn)評(píng)估的工具Determineriskfactors確定風(fēng)險(xiǎn)的因素Definethescalesfortheriskfactors界定風(fēng)險(xiǎn)因素的范圍Definetherisktermsand/ordevelopmatrix界定風(fēng)險(xiǎn)的類型或確定風(fēng)險(xiǎn)的矩陣Determinethethresholdforaction確定采取的行動(dòng)Riskevaluation風(fēng)險(xiǎn)評(píng)估Riskreduction風(fēng)險(xiǎn)降低Defineriskmitigatingmeasures確定風(fēng)險(xiǎn)降低的方法Riskacceptance風(fēng)險(xiǎn)接受OngoingRiskReview風(fēng)險(xiǎn)溝通和審核DocumentandApprove文件記錄和批準(zhǔn)RRF：RiskRankingandFiltering風(fēng)險(xiǎn)排列和過(guò)濾PHA：PreliminaryHazardAnalysis事先危害分析HVAC:HeatingVentilationAirConditioning空調(diào)凈化系統(tǒng)PreventiveMaintenance預(yù)防性維護(hù)PVC:PolyvinylChloride聚氯乙烯Calibration校準(zhǔn)GoodEngineeringPractice：良好的工程實(shí)踐EHS:Environment

Health

Safety環(huán)境、健康、安全PFD:ProcessFlowDiagrams工藝流程圖CPP:Criticalprocessparameters

關(guān)鍵工藝參數(shù)CIP:CleaningInPlace在線清潔SIP:SterilizationInPlace在線消毒Batchproduction批量生產(chǎn)Batchproductionrecords批生產(chǎn)記錄Batchrecords批記錄In-process

control

中間控制ResourceManagement資源管理ContractProduction委托生產(chǎn)ContractAnalysis委托檢驗(yàn)firstinfirstout先進(jìn)先出Reprocessing重新加工，返工criticalmaterials：關(guān)鍵物料HR:HumanResources人力資源PPT模板下載：/moban/

行業(yè)PPT模板：/hangye/

節(jié)日PPT模板：/jieri/PPT素材下載：/sucai/