GMP應用英語培訓

GMP相關英語分享者：質(zhì)量部李杰一、相關法規(guī)GMP：GoodManufacturePractice藥品生產(chǎn)質(zhì)量管理規(guī)范FDA：FoodandDrugAdministration美國食品藥品監(jiān)督管理局WHO:WorldHealthOrganization世界衛(wèi)生組織ICH:InternationalConferenceonHarmonization國際協(xié)調(diào)會議（研發(fā)注冊）SDA:StateDrugAdministration國家藥品監(jiān)督管理局ISO:InternationalOrganizationforStandardization國際標準化組織IPEC:InternationalPharmaceuticalExcipientsCouncil國際制藥工程協(xié)會EMEA:TheEuropeanAgencyfortheEvaluationofMedicinalProducts歐洲共同體藥物評審委員會PIC/S：PharmaceuticalInspectionConventionandPharmaceuticalInspectionCo-operationScheme國際藥品認證合作組織

ISPE:InternationalSocietyForPharmaceuticalEngineering國際制藥工程協(xié)會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RD:ResponsibilitiesofDepartments部門職責JR:JobResponsibilities崗位職責STP:StandardTechnologyProcedure技術標準TR:TechnicalRegulations工藝規(guī)程QS:QualityStandard質(zhì)量標準SMP:StandardManagementProcedure管理規(guī)程IM:InstitutionsandPersonnelManagement機構(gòu)與人員管理BM:BuildingsandFacilitiesManagement廠房與設施管理DM:DeviceManagement設備管理MM:MaterialManagement物料管理SC:SanitaryControl衛(wèi)生管理VM:VerificationManagement驗證管理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設備清潔操作SO:SanitaryOperation衛(wèi)生操作EO:EquipmentOperation設備操作TO:TestOperation檢驗操作MO:MaterialsmanagementOperation物料管理操作QO:QualitymanagementOperation質(zhì)量管理操作三、驗證文件中涉及到的英文VMP:ValidationMasterPlan驗證總計劃PVMP:ProjectValidationMasterPlan驗證項目總計劃AVP:AnnualValidationPlan年度驗證計劃VP:ValidationProtocol驗證方案VR:ValidationReport驗證報告BF:BuildingsandFacilities廠房設施EI:EquipmentandInstrument設備儀器DD:DisinfectioneffectofDisinfectant消毒劑消毒效果EC:EquipmentCleaning設備清潔MC:MethodofCalibration校驗方法URS:UserRequirementSpecification用戶需求標準FS:FunctionalSpecification功能標準FAT:FactoryAcceptanceTesting工廠（生產(chǎn)地）接受測試SAT:SiteAcceptanceTesting

安裝地接受測試DS:DesignSpecification設計標準DQ:DesignQualification設計確認IQ:InstallationQualification安裝確認OQ:OperationalQualification運行確認PQ:PerformanceQualification性能確認SIA:SystemImpactAssessment系統(tǒng)影響性評估CCA:ComponentCriticalityAssessment部件關鍵性評估OOS:OutOfSpecification檢驗結(jié)果偏差OOT:Out-of-Trend超趨勢RSD:RelativeStandardDeviation相對標準偏差FMEA:FailureModeandEffectsAnalysis失敗模式和影響分析FTA:FaultTreeAnalysis故障樹分析CAPA:CorrectiveActionandPreventiveAction糾正預防措施HACCP:HazardAnalysisandCriticalControlPoint

危害分析及關鍵控制點QRM:QualityRiskManagement質(zhì)量風險管理RP:RiskProtocol風險評估方案RR:RiskReport風險評估報告四、其他相關英文SR:SupplierForm供應商表格（供應商分級對照表）AR:AuditReport審計報告SL:SupplierList供應商清單BillofMaterials物料清單CCD:CertificationCommitteeforDrugs藥品認證管理中心CDER:CenterforDrugEvaluationandResearch藥品研究與評價中心CDC:CentersforDiseaseControlandPrevention疾病預防控制中心ADR:AdverseDrugReaction藥物不良反應ADE:AdverseDrugEvent藥品不良事件DMF:DrugMasterFile藥物管理檔案（藥物主文件）CQA:CriticalQualityAttributes關鍵質(zhì)量特性APR:AnnualProductReview年度質(zhì)量回顧MSDS:MaterialSafetyDataSheet物料安全數(shù)據(jù)說明書DS:DocumentationSystem文件系統(tǒng)QualifiedPerson質(zhì)量授權(quán)人Qualitysystem質(zhì)量系統(tǒng)CTD:CommonTechnicalDocument通用技術文件USA:UnitedStatesPharmacopeia美國藥典API:ActivePharmaceuticalIngredient活性藥用成分COA:CertificateOfAnalysis分析報告單HPLC:HighPerformanceLiquidChromatography高效液相色譜UV:Ultraviolet紫外TLC:ThinLayerChromatography薄層色譜TOC:TotalOrganicCarbon總有機碳量CFU:Colony-FormingUnits單位體積中的活菌個數(shù)

GC:GasChromatography氣相色譜IR:Infrared紅外ConfigurationSpecification:配制標準OTCdrug:Over-the-counterdrug非處方藥prescriptiondrug:處方藥Repetitionoftheanalysis:重新檢驗Repetitionoftheinjection:重新進樣Resampling:重新取樣Riskidentification風險識別Definetheriskquestion確定風險評估的問題Collectandorganiseinformation收集組織信息Riskanalysis風險分析Chooseriskassessmenttool選擇風險評估的工具Determineriskfactors確定風險的因素Definethescalesfortheriskfactors界定風險因素的范圍Definetherisktermsand/ordevelopmatrix界定風險的類型或確定風險的矩陣Determinethethresholdforaction確定采取的行動Riskevaluation風險評估Riskreduction風險降低Defineriskmitigatingmeasures確定風險降低的方法Riskacceptance風險接受OngoingRiskReview風險溝通和審核DocumentandApprove文件記錄和批準RRF：RiskRankingandFiltering風險排列和過濾PHA：PreliminaryHazardAnalysis事先危害分析HVAC:HeatingVentilationAirConditioning空調(diào)凈化系統(tǒng)PreventiveMaintenance預防性維護PVC:PolyvinylChloride聚氯乙烯Calibration校準GoodEngineeringPractice：良好的工程實踐EHS:Environment

Health

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

關鍵工藝參數(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firstinfirstout先進先出Reprocessing重新加工，返工criticalmaterials：關鍵物料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/