GMP英语.doc

GMP英语PIC/S的全称为:PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,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(ActivePharmaceuticalIngredient)原料药又称:活性药物组分AirLock气闸AuthorizedPerson授权人Batch/Lot批次BatchNumber/Lot-Number批号;BatchNumberingSystem批次编码系统;BatchRecords批记录;BulkProduct待包装品;Calibration校正;Cleanarea洁净区;t(Delivery)托销药品。FDA(FOODANDDRUGADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONALNEWDRUG):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(NEWDRUGAPPLICATION):新药申请ANDA(ABBREVIATEDNEWDRUGAPPLICATION):简化新药申请TREATMENTIND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUGMASTERFILE):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(CODEOFFEDERALREGULATION):(美国)联邦法规PANEL:专家小组BATCHPRODUCTION:批量生产;分批生产BATCHPRODUCTIONRECORDS:生产批号记录POST-ORPRE-MARKETSURVEILLANCE:销售前或销售后监督INFORMEDCONSENT: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)PRESCRIPTIONDRUG:处方药OTCDRUG(OVER—THE—COUNTERDRUG):非处方药GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:hemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificat