常用药品注册生产英文

缩写词APIActivePharmaceuticalIngredient原料药ANDAAbbreviatedNewDrugApplication简化新药申请仿制药ASMTheActiveSubstanceManufacturer原料药生产厂家ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应CFDAChinaFoodandDrugAdministration中国国家食品药品监督管理局COSCertificateofSuitability欧洲药典适用性认证CTDCommonTechnicalDocuments通用技术文件COACertificatofAnalysis检验报告CDECenterforDrugEvaluation药品审评中心CMCChemistry,ManufactureandControl化学，生产及质控CROContractResearchOrgnization合同研究组织ChPChinesePharmacopoeia中国药典CASChemicalAbstractsService美国化学文摘社CTAClinicalTrailApplication临床试验申请CMOCheifMedicalOfficer首席医学官CPPCertificateofaPharmaceuticalProduct药品证明文书CAPACorrectiveandPreventiveAction纠正预防行动DMFDrugMasterFile药品主文件EDMFEuropeanDrugMasterFile欧洲药物管理档案EMEAEuropeanAgencyfortheEvaluationofMedicinalProduct欧洲药物评审局EUEuropeanUnion欧洲联盟EPEuropeanPharmacopoeia欧洲药典FDAFoodandDrugAdministration食品药品监督管理局（美国药监局）GMPGoodManufacturingPractices良好生产规范HPLCHighPerformanceLiquidChromatography高效液相ICHInternationalConferenceofHarmonization国际协调会议INDInvestigationalNewDrugApplication新药临床试验申请IDLImportDrugLicense进口药品注册证书INNInternationalNonproprietatyName国际非专有名称LALetterofAuthorization委托书LOQLimitofQuantity定量限LODLimitofDetection检测限MAMarketingAuthorization上市许可NDANewDrugApplication新药生产上市申请NIFDCNationalInstitutesforFoodandDrugControl中国食品药品检定研究院NMTNotMoreThan不大于NANotAnalysis未检测OTCOverTheCounter非处方药OOSOutofSpecification不合格PSURPeriodicSafetyUpdateReports定期安全性报告QOSTheQualityOverallSummary质量整体概述QAQulitityAssurance质量保证QCQulitityControl质量控制RxPrescriptionDrug处方药RSReferenceStandard对照品SOPStandardOperationProcedure标准操作规范TSTestSolutions指示剂UVUltraviolet紫外分光光度法USPUnitedStatesPharmacopoeia美国药典药品注册词汇Drugregistrationapplication注册申请Supplementaryapplication补充申请Drugregulatorydepartment药品监管部门Re-registrationapplication再注册On-siteinspection现场核查Productionsiteinspection生产现场核查Causalinspection有因核查Authenticity真实性Precision准确性Integrity完整性Entrustedagency代理机构Dosageform剂型Formula处方Preparingprocess生产工艺Testingmethods检验方法Qualityspecifications质量指标Stability稳定性Drugapprovalnumber批准文号Methodverification方法验证Manufacturer生产厂家Plant工厂Productionline生产线Workshop车间Safety安全性Efficacy有效性Acceptance受理Applicant申请人Biologicalproduct生物制品Preliminaryreview初步审核Variation变更Rawdata原始数据Specificationsverification标准复核Secondreview复审GMPcertificate生产质量管理规范证书Applicationdossers申请文件CenterforfoodanddruginspectionofCFDACFDA食品药品审核查验中心产品英语部分streptococcuspneumoniae肺炎链球菌Streptococcuspyogenes酿脓性链球菌Branhamellacatarrhalis卡他布兰汉姆菌staphylococcusaureus金黄色葡萄球菌HaemophilusinfluenzaetypeBB型流感嗜血杆菌Klebsiellapneumoniae肺炎克雷伯杆菌Manufacturingprocess生产过程Processcontrol过程控制Lysate裂解物Culture培养培养基Ultrafiltration滤过，超滤Inactivation灭活Autolysis自溶Alkaline碱性的Bacterialstrain菌株Revitalize复原，激活Sub-culture传代培养Inoculate嫁接Fermenter发酵器Cultivate培养Stir搅拌Concentrate浓缩Turbidity浑浊度Fungi真菌Elimination消除Identify鉴别Purity纯度Germ细菌，病菌Liter升Microbiologicalcontrol微生物控制Thimerosal硫柳汞Sodiummethyl-paraben对羟基苯甲酸甲酯钠Doseanduniformityofdose剂量及均一性Chlorhexidinediacetate乙酰乙酸氯已定Polysorbate80吐温80（聚山梨酯80）Antigenicactivity抗原活性Rocketimmunoeletroforesis火箭电泳法Excipient辅料Steriledistilledwater无菌注射用水Purifiedwater纯化水Appearance性状Container包装Surfactant表面活性剂Preservative防腐剂Leaflet说明书Activeingredients活性成分Approvaldocuments批准证明文件Researchdata研究资料Stability稳定性Validationofmethod方法学验证