制藥行業(yè)術(shù)語(yǔ)及藥政、行業(yè)組織簡(jiǎn)稱

1、在耳 J 丁 p英文縮寫英文全稱中文全稱首字母A1ACAir Conditioner空調(diào)2ADRAdverse Drug Reaction藥品不良的反應(yīng)3AHUAir Handling Unit空氣處理單元4APIActive Pharmaceutical Ingredient活性藥物組分（原料藥）5ASTMAmerican Society for Testing and Materials(International)美國(guó)材料與試驗(yàn)協(xié)會(huì)（國(guó)際）6APICActive Pharmaceutical Ingredients Committee歐洲原料藥協(xié)會(huì)首字母B1BOMBill of Mate

2、rial物料清單2BPBritish Pharmacopeia英國(guó)藥典3BRBatch Record批記錄首字母C1CCAComponent Criticality Assessment部件關(guān)鍵性評(píng)估2CAPACorrective and Preventive Action糾止預(yù)防措施3CFUColony Forming Unit菌落形成單位4cGMPCurrent Good Manufacturing Practice現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范5CIPCleaning In Place在線清洗6CNCControlled Not Classified控制未分類7COACertificate o

3、f Analysis分析報(bào)告單8COPCleaning Out of Place離線清洗9CPPCritical Process Parameters關(guān)鍵工藝參數(shù)10CQACritical Quality Attributes關(guān)鍵質(zhì)量特性11CROContract Research Organization合同研究組織（外包）12CSComputerized System計(jì)算機(jī)化系統(tǒng)13CTDCommon Technical Document通用技術(shù)文件14CVCleaning Validation清潔驗(yàn)證15CMCChemistry Manufacturing Control化學(xué)制造控制16

4、CDCCenters for Disease Control and Prevention疾病預(yù)防與控制中心17CEPCertificate of Suitability for European Pharmacopeia歐洲藥典適用性證書18ChPPharmacopoeia of the Peoples Republic of China中國(guó)約典委員會(huì)19CDECenter For Drug Evaluation中國(guó)約品審評(píng)中心20CFDICenter For Food And Drug Inspection Of NMPA中國(guó)藥品審核查驗(yàn)中心21CDRChina Adverse Drug

5、Reaction Monitoring Center中國(guó)約品不良反應(yīng)監(jiān)測(cè)中心在耳J 丁 p英文縮寫英文全稱中文全稱首字母D1DMFDrug Master File藥物主文件2DPDifferential Pressure壓差3DQDesign Qualification設(shè)計(jì)確認(rèn)4DSDesign Specification設(shè)計(jì)說(shuō)明5DRDesign Review設(shè)計(jì)評(píng)審6DSCDistributed Control System集散控制系統(tǒng)首字母E1EDIElectro-de-ionization電去離子2EHSEnvironment, Health and Safety環(huán)境，健康和安全3EU

6、-GMPEuropean Good Manufacturing Practice歐洲GMP4EPEuropean Pharmacopoeia歐洲藥典5EDQMEuropean Directorate for the Quality of Medicines歐洲藥品質(zhì)量管理局6EMAEuropean Medicines Agency歐洲藥品管理局7EUEuropean Union歐盟首字母F1FATFactory Acceptance Test出廠驗(yàn)收測(cè)試2FMEAFailure Mode Effects Analysis失效模式與影響分析3FMECAFailure Mode, Effects

7、and Criticality Analysis失效模式影響分析（FMEA ） 和危害性分析（CA）4FSFunctional Specification功能說(shuō)明5FDAFood and Drug Administration( US)美國(guó)食品藥品監(jiān)督管理局首字母G1GAMPGood Automated Manufacturing Practice優(yōu)良自動(dòng)化生產(chǎn)管理規(guī)范2GCGas Chromatography氣相色譜3GCPGood Clinical Practice藥品臨床研究管理規(guī)范4GEPGood Engineering Practice優(yōu)良工程管理規(guī)范5GLPGood Laborat

8、ory Practice藥品非臨床研究質(zhì)量管理規(guī) 范6GMPGood Manufacturing Practice藥品生產(chǎn)質(zhì)量管理規(guī)范7GSPGood Supply Practice藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范首字母H1HACCPHazard Analysis and Critical Control Point危害分析和關(guān)鍵環(huán)節(jié)控制點(diǎn)在耳 J 丁 p英文縮寫英文全稱Hazard and Operability Analysis中文全稱2HAZOP危害與可操作性分析3HEPAHigh Efficiency Particulate Air圖效空氣過(guò)濾器4HMIHuman Machine Interfac

9、e人機(jī)界囿5HPLCHigh Performance Liquid Chromatography局效液相色譜6HVACHeating Ventilation and Air Conditioning暖通空調(diào)系統(tǒng)首字母I1IAImpact Assessment影響評(píng)估2INDInvestigational New Drug臨床研究申請(qǐng)3INNInternational Non-proprietary Name國(guó)家非專利名4IPCIn-process Controls過(guò)程控制5IQInstallation Qualification安裝確認(rèn)6IRInfrared Spectrophotometer

10、紅外分光光度計(jì)7ISOInternational Standard Organization國(guó)際標(biāo)準(zhǔn)化組織8ISPEInternational Society for Pharmaceutical Engineering國(guó)際制藥工程協(xié)會(huì)9ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用藥品注冊(cè)技術(shù)要求國(guó)際 協(xié)調(diào)會(huì)首字母J1JPJapanese Pharmacopoeia日本藥典首字母L1LAFLami

11、nar Air Flow單向流2LELLower Explosion Limit爆炸下限3LEVLocal Exhaust Ventilation局部排風(fēng)4LODLimit of Detection檢測(cè)限5LOQLimit of Quantitation定量限首字母M1MAMarketing Authorization上市許可2MAAMarketing Authorization Application上市申請(qǐng)3MBRMaster Batch Record主批生產(chǎn)記錄4MOAMethod Of Analysis分析方法5MSDSMaterial Safety Data Sheet化學(xué)品安全技術(shù)

12、說(shuō)明書6MHRAMedicines And Healthcare Products Regulatory Agency英國(guó)藥品管理局首字母N在耳 J 丁 p英文縮寫英文全稱中文全稱1NDANew Drug Application新藥申請(qǐng)2NFNational Formulary美國(guó)國(guó)家藥品集3NIFDCNational Institutes for Food and Drug Control中國(guó)食品藥品檢定研究院4NMPANational Medical Products Administration中國(guó)藥品監(jiān)督管埋局首字母O1OOSOut of Specification超標(biāo)2OOTOut

13、of Trend超出正常趨勢(shì)3OQOperation Qualification運(yùn)行確認(rèn)4OSDOral Solid Dosage口服固體制劑5OTCOver-the-counter非處方6OSHAOccupational Safety and Health Administration(US)職業(yè)安全與健康署（美國(guó)）首字母P1P&IDPiping and Instruments Diagram管路及儀表布置圖2PATProcess Analytical Technology過(guò)程分析技術(shù)3PDCAPlan, Do, Check, Action計(jì)劃、執(zhí)行、檢查、處理4PFDSProcess Fl

14、ow Diagrams上2流程圖5PHAPreliminary Hazard Analysis初步危害分析6PIPackage Insert說(shuō)明書7PLCProgrammable Logic Controller可編輯邏輯控制器8PMPreventive Maintenance預(yù)防性維修9PPEPersonal Protective Equipment個(gè)人防護(hù)設(shè)備10PPMParts Per Million每白刃分之一11PQPerformance Qualification性能確認(rèn)12PQRProduct Quality Review產(chǎn)品質(zhì)量回顧13PSPure Steam純烝汽14PVPr

15、ocess Validation工藝驗(yàn)證15PVPProject Validation Plan項(xiàng)目驗(yàn)證計(jì)劃16PVRProject Validation Report項(xiàng)目驗(yàn)證報(bào)告17PWPurified Water純化水18PDAParenteral Drug Association國(guó)際注射劑協(xié)會(huì)19PIC/SPharmaceutical Inspection Convention/ PharmaceuticalInspection Co-operation Scheme國(guó)際醫(yī)約品檢查組織首字母Q在耳 J 丁 p英文縮寫英文全稱中文全稱1QAQuality Assurance質(zhì)量保證2QbD

16、Quality by Design質(zhì)量源于設(shè)計(jì)3QCQuality Control質(zhì)量控制4QMSQuality Management System質(zhì)量管理體系5QRMQuality Risk Management質(zhì)量風(fēng)險(xiǎn)管理首字母R1RARisk Analysis風(fēng)險(xiǎn)分析2RHRelative Humidity相對(duì)濕度3ROReverse Osmosis反滲透首字母S1SATSite Acceptance Test現(xiàn)場(chǎng)驗(yàn)收測(cè)試2SIInternational System of Unit國(guó)際單位制3SIASystem Impact Assessment系統(tǒng)影響評(píng)估4SIPSterilize

17、In Place (Steam In Place )在線火菌5SMStarting Material起始物料6SMFSite Master File工廠主文件7SMPStandard Management Procedure標(biāo)準(zhǔn)管理程序8SOPStandard Operating Procedure標(biāo)準(zhǔn)操作規(guī)程首字母T1TLCThin-Layer Chromatography薄層色譜2TOCTotal Organic Carbon總有機(jī)碳3TSTechnical Specification技術(shù)標(biāo)準(zhǔn)文件首字母U1UDFUnidirectional Flow單向流2ULPAUntra Low Penetration Air超高效空氣過(guò)濾器3UPSUninterrupted Power Supply不間斷電源4URSUser Requirement Specification用戶需求