制藥英文縮寫詞表

1、精選優(yōu)質(zhì)文檔-傾情為你奉上常見詞匯縮寫英文縮寫英文全稱中文AAC Air Conditioner空調(diào)ADR Adverse Drug Reaction藥品不良反應(yīng)AHUAir Handling Unit空氣處理單元APIActive Pharmaceutical Ingredient活性藥物組分（原料藥）ANDAAbbreviated New Drug Application簡略新藥申請AQL  Acceptable Quality Level可接受質(zhì)量水平ASM Active Substance Manufacturer活性物質(zhì)生產(chǎn)商ASMEAmerican Societ

2、y of Mechanical Engineers 美國機(jī)械工程師協(xié)會BBMSBuilding Monitoring System 樓宇監(jiān)測系統(tǒng)BOM    Bill of Material物料清單BPBritish Pharmacopoeia英國藥典BPC Bulk pharmaceutical Chemicals 原料藥CCAPA Corrective and Preventive Action糾正預(yù)防措施CCAComponent Criticality Assessment組件關(guān)鍵性評估CEPCertificate of Suitabil

3、ity for European Pharmacopeia歐洲藥典適用性證書CFRCode of Federal Regulations美國聯(lián)邦法規(guī)CFU   Colony Forming Unit  菌落形成單位CHWChilled Water冷凍水CIP  Clean in Place  在線清洗CIPCCritical In-Process Control關(guān)鍵中間控制點(diǎn)CNCControlled Non-Classified 控制但未分級COA Certificate of Analysis分析報告單COMCommis

4、sioning試車COPClean out of Place 離線清洗CPPCritical Process Parameter關(guān)鍵工藝參數(shù)CQACritical Quality Attribute關(guān)鍵質(zhì)量屬性CROContract Research Organization合同研究組織（外包）CSComputerized System計算機(jī)系統(tǒng)CTD Common Technical Document通用技術(shù)文件CVCleaning Validation清潔驗證CMCChemistry Manufacturing Control化學(xué)制造控制DDMFDrug Master File藥

5、物主文件DSDesign Specification 設(shè)計說明EEDQMEuropean Directorate for the Quality of Medicines & HealthCare歐洲藥品與健康質(zhì)量理事會EHSEnvironment, Health and Safety 環(huán)境、健康和安全EMAEuropean Medicines Agency歐洲藥監(jiān)局EP European Pharmacopoeia歐洲藥典FFATFactory Acceptance Test 出廠驗收測試FDAFOOD AND DRUG ADMINISTRATION（美國）食品藥品監(jiān)督管理局FDSF

6、unction Design Specification功能設(shè)計說明FEMAFailure Mode and Effects Analysis 失效模式及后果分析FFUFan Filter Unit風(fēng)機(jī)過濾單元FMSFacility Monitoring System設(shè)施監(jiān)控系統(tǒng)FSFunctional Specification功能說明GGAMPGood Automated Manufacturing Practice優(yōu)良自動化生產(chǎn)管理規(guī)范GCP Good Clinical Practice藥品臨床研究管理規(guī)范GEPGood Engineering Practice優(yōu)良工程管理規(guī)范GLP G

7、ood Laboratory Practice藥品臨床前安全性研究質(zhì)量管理規(guī)范GMPGood Manufacturing Practice藥品生產(chǎn)質(zhì)量管理規(guī)范GSP Good Supply Practice藥品經(jīng)營質(zhì)量管理規(guī)范HHACCPHazard Analysis and Critical Control Point危害分析和關(guān)鍵環(huán)節(jié)控制點(diǎn)HEPAHigh Efficiency Particulate Air高效空氣過濾器HMIHuman Machine Interface 人機(jī)界面HVAC  Heating Ventilation Air Conditioning 供

8、熱、通風(fēng)與空調(diào)系統(tǒng)IICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use人用藥品注冊技術(shù)要求國際協(xié)調(diào)會INDINVESTIGATIONAL NEW DRUG臨床研究申請INN International Non-proprietary Name國際非專利名IQInstallation Qualification 安裝確認(rèn)ISPEInternational Society for Pharmaceutical

9、 Engineering國際制藥工程協(xié)會LLIMSLaboratory Information Management System實驗室信息管理系統(tǒng)MMA Marketing Authorisation上市許可MAA Marketing Authorisation Application上市申請MBRMaster Batch Record主生產(chǎn)批記錄NNDANEW DRUG APPLICATION新藥申請OQAQuality Assurance質(zhì)量保證QbDQuality by Design質(zhì)量源于設(shè)計QC Quality Control質(zhì)量控制OFDOperation Flow Diagra

10、m操作流程圖OOSOut of Specification 超標(biāo)OOTOut of Trend超出正常趨勢OQOperational Qualification 運(yùn)行確認(rèn)PPATProcess Analytical Technology過程分析技術(shù)PCSProcess Control System 工藝控制系統(tǒng)PIC/SPharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme藥品檢查公約/藥品檢查合作計劃PID Piping and Instruments Diagram管路及儀表布置圖P

11、LCProgrammable Logic Controller 可編程邏輯控制器PMDProcess Module Diagram工藝模塊圖POUPoint of Use使用點(diǎn)PQPerformance Qualification 性能確認(rèn)PQRProduct Quality Review產(chǎn)品質(zhì)量回顧PWPurified Water 純化水PSPure Steam 純蒸汽PVProcess Validation工藝驗證QQMQuality Management 質(zhì)量管理QMSQuality Management System質(zhì)量管理體系RRABSRestricted Access Barrie

12、r System限制進(jìn)入隔離系統(tǒng)RTMRequirements Traceability Matrix需求追溯矩陣SSATSite Acceptance Test 現(xiàn)場驗收測試SCADASupervisory Control and Data Acquisition System 數(shù)據(jù)采集與監(jiān)控系統(tǒng)SIA System Impact Assessment系統(tǒng)影響評估SIP Sterilize In Place (Steam In Place)在線滅菌SMF Site Master File工廠主文件SOPStandard Operational Procedure 標(biāo)準(zhǔn)操作規(guī)程TTOCTotal Organic Carbon 總有機(jī)碳UUDFUnidirection