制药行业术语及药政、行业组织简称

1、在耳 J 丁 p英文缩写英文全称中文全称首字母A1ACAir Conditioner空调2ADRAdverse Drug Reaction药品不良的反应3AHUAir Handling Unit空气处理单元4APIActive Pharmaceutical Ingredient活性药物组分（原料药）5ASTMAmerican Society for Testing and Materials(International)美国材料与试验协会（国际）6APICActive Pharmaceutical Ingredients Committee欧洲原料药协会首字母B1BOMBill of Mate

2、rial物料清单2BPBritish Pharmacopeia英国药典3BRBatch Record批记录首字母C1CCAComponent Criticality Assessment部件关键性评估2CAPACorrective and Preventive Action纠止预防措施3CFUColony Forming Unit菌落形成单位4cGMPCurrent Good Manufacturing Practice现行药品生产质量管理规范5CIPCleaning In Place在线清洗6CNCControlled Not Classified控制未分类7COACertificate o

3、f Analysis分析报告单8COPCleaning Out of Place离线清洗9CPPCritical Process Parameters关键工艺参数10CQACritical Quality Attributes关键质量特性11CROContract Research Organization合同研究组织（外包）12CSComputerized System计算机化系统13CTDCommon Technical Document通用技术文件14CVCleaning Validation清洁验证15CMCChemistry Manufacturing Control化学制造控制16

4、CDCCenters for Disease Control and Prevention疾病预防与控制中心17CEPCertificate of Suitability for European Pharmacopeia欧洲药典适用性证书18ChPPharmacopoeia of the Peoples Republic of China中国约典委员会19CDECenter For Drug Evaluation中国约品审评中心20CFDICenter For Food And Drug Inspection Of NMPA中国药品审核查验中心21CDRChina Adverse Drug

5、Reaction Monitoring Center中国约品不良反应监测中心在耳J 丁 p英文缩写英文全称中文全称首字母D1DMFDrug Master File药物主文件2DPDifferential Pressure压差3DQDesign Qualification设计确认4DSDesign Specification设计说明5DRDesign Review设计评审6DSCDistributed Control System集散控制系统首字母E1EDIElectro-de-ionization电去离子2EHSEnvironment, Health and Safety环境，健康和安全3EU

6、-GMPEuropean Good Manufacturing Practice欧洲GMP4EPEuropean Pharmacopoeia欧洲药典5EDQMEuropean Directorate for the Quality of Medicines欧洲药品质量管理局6EMAEuropean Medicines Agency欧洲药品管理局7EUEuropean Union欧盟首字母F1FATFactory Acceptance Test出厂验收测试2FMEAFailure Mode Effects Analysis失效模式与影响分析3FMECAFailure Mode, Effects

7、and Criticality Analysis失效模式影响分析（FMEA ） 和危害性分析（CA）4FSFunctional Specification功能说明5FDAFood and Drug Administration( US)美国食品药品监督管理局首字母G1GAMPGood Automated Manufacturing Practice优良自动化生产管理规范2GCGas Chromatography气相色谱3GCPGood Clinical Practice药品临床研究管理规范4GEPGood Engineering Practice优良工程管理规范5GLPGood Laborat

8、ory Practice药品非临床研究质量管理规 范6GMPGood Manufacturing Practice药品生产质量管理规范7GSPGood Supply Practice药品经营质量管理规范首字母H1HACCPHazard Analysis and Critical Control Point危害分析和关键环节控制点在耳 J 丁 p英文缩写英文全称Hazard and Operability Analysis中文全称2HAZOP危害与可操作性分析3HEPAHigh Efficiency Particulate Air图效空气过滤器4HMIHuman Machine Interfac

9、e人机界囿5HPLCHigh Performance Liquid Chromatography局效液相色谱6HVACHeating Ventilation and Air Conditioning暖通空调系统首字母I1IAImpact Assessment影响评估2INDInvestigational New Drug临床研究申请3INNInternational Non-proprietary Name国家非专利名4IPCIn-process Controls过程控制5IQInstallation Qualification安装确认6IRInfrared Spectrophotometer

10、红外分光光度计7ISOInternational Standard Organization国际标准化组织8ISPEInternational Society for Pharmaceutical Engineering国际制药工程协会9ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药品注册技术要求国际 协调会首字母J1JPJapanese Pharmacopoeia日本药典首字母L1LAFLami

11、nar Air Flow单向流2LELLower Explosion Limit爆炸下限3LEVLocal Exhaust Ventilation局部排风4LODLimit of Detection检测限5LOQLimit of Quantitation定量限首字母M1MAMarketing Authorization上市许可2MAAMarketing Authorization Application上市申请3MBRMaster Batch Record主批生产记录4MOAMethod Of Analysis分析方法5MSDSMaterial Safety Data Sheet化学品安全技术

12、说明书6MHRAMedicines And Healthcare Products Regulatory Agency英国药品管理局首字母N在耳 J 丁 p英文缩写英文全称中文全称1NDANew Drug Application新药申请2NFNational Formulary美国国家药品集3NIFDCNational Institutes for Food and Drug Control中国食品药品检定研究院4NMPANational Medical Products Administration中国药品监督管埋局首字母O1OOSOut of Specification超标2OOTOut

13、of Trend超出正常趋势3OQOperation Qualification运行确认4OSDOral Solid Dosage口服固体制剂5OTCOver-the-counter非处方6OSHAOccupational Safety and Health Administration(US)职业安全与健康署（美国）首字母P1P&IDPiping and Instruments Diagram管路及仪表布置图2PATProcess Analytical Technology过程分析技术3PDCAPlan, Do, Check, Action计划、执行、检查、处理4PFDSProcess Fl

14、ow Diagrams上2流程图5PHAPreliminary Hazard Analysis初步危害分析6PIPackage Insert说明书7PLCProgrammable Logic Controller可编辑逻辑控制器8PMPreventive Maintenance预防性维修9PPEPersonal Protective Equipment个人防护设备10PPMParts Per Million每白刃分之一11PQPerformance Qualification性能确认12PQRProduct Quality Review产品质量回顾13PSPure Steam纯烝汽14PVPr

15、ocess Validation工艺验证15PVPProject Validation Plan项目验证计划16PVRProject Validation Report项目验证报告17PWPurified Water纯化水18PDAParenteral Drug Association国际注射剂协会19PIC/SPharmaceutical Inspection Convention/ PharmaceuticalInspection Co-operation Scheme国际医约品检查组织首字母Q在耳 J 丁 p英文缩写英文全称中文全称1QAQuality Assurance质量保证2QbD

16、Quality by Design质量源于设计3QCQuality Control质量控制4QMSQuality Management System质量管理体系5QRMQuality Risk Management质量风险管理首字母R1RARisk Analysis风险分析2RHRelative Humidity相对湿度3ROReverse Osmosis反渗透首字母S1SATSite Acceptance Test现场验收测试2SIInternational System of Unit国际单位制3SIASystem Impact Assessment系统影响评估4SIPSterilize

17、In Place (Steam In Place )在线火菌5SMStarting Material起始物料6SMFSite Master File工厂主文件7SMPStandard Management Procedure标准管理程序8SOPStandard Operating Procedure标准操作规程首字母T1TLCThin-Layer Chromatography薄层色谱2TOCTotal Organic Carbon总有机碳3TSTechnical Specification技术标准文件首字母U1UDFUnidirectional Flow单向流2ULPAUntra Low Penetration Air超高效空气过滤器3UPSUninterrupted Power Supply不间断电源4URSUser Requirement Specification用户需求