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医药行业专业英语词汇_非常有用_

FDA和EDQM术语:QC、QA、IPQC、JQE、DQA、SQE是什么?这些职位的全称都是什么?有什么区别?QC中文全称: 即英文QUALITY CONTROL的简称,中文意义是品质控制,质量检验。

其在ISO8402:1994的定义是“为达到品质要求所采取的作业技术和活动”。

有些推行ISO9000的组织会设置这样一个部门或岗位,负责ISO9000标准所要求的有关品质控制的职能,担任这类工作的人员就叫做QC人员,相当于一般企业中的产品检验员,包括进货检验员(IQC)、制程检验员(IPQC)、最终检验员(FQC)和出货检验员(OQC)。

QA中文全称:即英文QUALITY ASSURANCE 的简称, 中文意思是品质保证,质量保证。

其在ISO8402:1994中的定义是“为了提供足够的信任表明实体能够满足品质要求,而在品质管理体系中实施并根据需要进行证实的全部有计划和有系统的活动”。

有些推行ISO9000的组织会设置这样的部门或岗位,负责ISO9000标准所要求的有关品质保证的职能,担任这类工作的人员就叫做QA 人员。

IPQC:即英文In-process Quality Control 的简称, 中文意思是制程检验,担任这类工作的人员叫做制程检验员。

JQE:即英文Joint Qualit Engineer 的简称, 中文意思是品质工程师或客户端工程师,或客户端品质工程师,即供应商花钱雇用的为客户工作的品质工程师,是客户SQE的眼睛和耳朵。

iDQA:即英文Design Quality Assurance 的简称, 中文意思是设计品质保证,如DQA经理(设计品质认证经理)。

SQE:即英文Supplier Quality Engineer 的简称, 中文意思是供应商品质工程师。

此外,还有DQC:即英文Design Quality Control 的简称, 中文意思是设计品质控制。

CLINICAL TRIAL:临床试验 clinical trialANIMAL TRIAL:动物试验animal trialACCELERATED APPROV AL:加速批准 accelerated approvalSTANDARD DRUG:标准药物 standard drugINVESTIGATOR:研究人员;调研人员 investigatorPREPARING AND SUBMITTING:起草和申报 preparing and submittingSUBMISSION:申报;递交 submissionBENIFIT(S):受益 benifitRISK(S):受害riskDRUG PRODUCT:药物产品 drug productDR(drug substance)原料药 API(Active Pharmaceutical Ingrediet) 原料药又称:活性药物组分ESTABLISHED NAME:确定的名称 established nameGENERIC NAME:非专利名称 generic namePROPRIETARY NAME:专有名称; proprietary nameINN(INTERNATIONAL NONPROPRIETARY NAME):国际非专有名称international nonproprietaty name ADVERSE EFFECT:副作用 adverse effectADVERSE REACTION:不良反应adverse reactionPROTOCOL:方案 protocolARCHIV AL COPY:存档用副本 archival copy archival copyREVIEW COPY:审查用副本 rreview copyOFFICIAL COMPENDIUM:法定药典(主要指USP、 NF). Official compendiumUSP(THE UNITED STATES PHARMACOPEIA):美国药典 pharmacopeia英音:[,fɑ:məkə'pi:ə] pharmaceutical英音:[,fɑ:mə'sju:tikl]NF(NATIONAL FORMULARY):(美国)国家处方集 national formularyOFFICIAL=PHARMACOPEIAL= COMPENDIAL:药典的;法定的;官方的 compendial AGENCY:审理部门(指FDA) agencyIDENTITY:真伪;鉴别;特性identitySTRENGTH:规格;规格含量(每一剂量单位所含有效成分的量)strengthLABELED AMOUNT:标示量 labeled amountREGULATORY SPECIFICATION:质量管理规格标准(NDA提供) regulatory specification REGULATORY METHODOLOGY:质量管理方法 regulatory methodologyREGULATORY METHODS V ALIDATION:管理用分析方法的验证 validationmedical apparatus and instruments: 医疗器械pharmaceutical factory:药厂drugstore; chemist's shop; pharmacy:药店pharmacopeia: 药典prescription: 药方write out a prescription: 开药方drugstore; chemist's shop; pharmacy: 医药商店hospital pharmacy; disp(转载自第一范文网,请保留此标记。

)ensary: 医院或诊所里的药房expenses for medicine; charges for medicine: 药费a pot for decocting herbal medicine: 药罐子chronic invalid: 药罐子(经常生病的人)apothecaries' measure or weight: 药衡medicinal herb collector; herbalist: 药农herbal medicine shop: 药铺COS/CEP 欧洲药典符合性认证ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。

质量技术要求文件以Q开头,再以a,b,c,d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:(原料药的优良制造规范指南)药物活性成分的GMP.GMP英语PIC/S的全称为:Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药又称:活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration校正;Clean area洁净区;Consignmecnt(Delivery)托销药品。

FDA(FOOD AND DRUG ADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONAL NEW DRUG):investigational new drug 临床研究申请(指申报阶段,相对于NDA而言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEW DRUG APPLICATION):new drug application新药申请ANDA(ABBREVIATED NEW DRUG APPLICATION):简化新药申请 abbreviated new drug applicationTREATMENT IND:treatment ind研究中的新药用于治疗ABBREVIATED(NEW)DRUG:abbreviated new drug简化申请的新药DMF(DRUG MASTER FILE):drug master file 药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODE OF FEDERAL REGULATION):(美国)联邦法规PANEL:专家小组 panelBATCH PRODUCTION:批量生产;分批生产 batch productionBATCH PRODUCTION RECORDS:生产批号记录batch production recordsPOST-OR PRE- MARKET SURVEILLANCE:post-or pre-market surveillance销售前或销售后监督INFORMED CONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验) informed consentPRESCRIPTION DRUG:处方药 presctiption drugOTC DRUG(OVER—THE—COUNTER DRUG):非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOV A Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products)欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (STANDARD OPERATION PROCEDURE)标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US Pharmacopoeia英音:[,fɑ:məkə'pi:ə]VMF Veterinary Master FileVPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会(美国)ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范。

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