1、精選優質文檔-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ADR Adverse Drug Reaction藥品不良反應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可接受質量水平ASM Active Substance Manufacturer活性物質生產商ASMEAmerican Societ

2、y of Mechanical Engineers 美國機械工程師協會BBMSBuilding Monitoring System 樓宇監測系統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糾正預防措施CCAComponent Criticality Assessment組件關鍵性評估CEPCertificate of Suitabil

3、ity for European Pharmacopeia歐洲藥典適用性證書CFRCode of Federal Regulations美國聯邦法規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關鍵中間控制點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關鍵工藝參數CQACritical Quality Attribute關鍵質量屬性CROContract Research Organization合同研究組織（外包）CSComputerized System計算機系統CTD Common Technical Document通用技術文件CVCleaning Validation清潔驗證CMCChemistry Manufacturing Control化學制造控制DDMFDrug Master File藥

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

6、unction Design Specification功能設計說明FEMAFailure Mode and Effects Analysis 失效模式及后果分析FFUFan Filter Unit風機過濾單元FMSFacility Monitoring System設施監控系統FSFunctional Specification功能說明GGAMPGood Automated Manufacturing Practice優良自動化生產管理規范GCP Good Clinical Practice藥品臨床研究管理規范GEPGood Engineering Practice優良工程管理規范GLP G

7、ood Laboratory Practice藥品臨床前安全性研究質量管理規范GMPGood Manufacturing Practice藥品生產質量管理規范GSP Good Supply Practice藥品經營質量管理規范HHACCPHazard Analysis and Critical Control Point危害分析和關鍵環節控制點HEPAHigh Efficiency Particulate Air高效空氣過濾器HMIHuman Machine Interface 人機界面HVAC  Heating Ventilation Air Conditioning 供

8、熱、通風與空調系統IICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use人用藥品注冊技術要求國際協調會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ISPEInternational Society for Pharmaceutical

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

10、m操作流程圖OOSOut of Specification 超標OOTOut of Trend超出正常趨勢OQOperational Qualification 運行確認PPATProcess Analytical Technology過程分析技術PCSProcess Control System 工藝控制系統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PQPerformance Qualification 性能確認PQRProduct Quality Review產品質量回顧PWPurified Water 純化水PSPure Steam 純蒸汽PVProcess Validation工藝驗證QQMQuality Management 質量管理QMSQuality Management System質量管理體系RRABSRestricted Access Barrie

12、r System限制進入隔離系統RTMRequirements Traceability Matrix需求追溯矩陣SSATSite Acceptance Test 現場驗收測試SCADASupervisory Control and Data Acquisition System 數據采集與監控系統SIA System Impact Assessment系統影響評估SIP Sterilize In Place (Steam In Place)在線滅菌SMF Site Master File工廠主文件SOPStandard Operational Procedure 標準操作規程TTOCTotal Organic Carbon 總有機碳UUDFUnidirection