藥品生產(chǎn)常用詞匯中英文對照表環(huán)境，健康，安全environment,health,safety,EHS質(zhì)量風(fēng)險管理qualityriskmanagement,QRM風(fēng)險評估riskassessment風(fēng)險控制riskcontrol事先危害分析preliminaryhazardanalysis,PHA失敗模式效果分析failuremodeeffectsanalysis，F(xiàn)MEA危害分析與主要控制點hazardanalysisandcriticalcontrolpoints,HACCP過失樹分析faulttreeanalysis,FTA兩次失敗之間的平均時間meantimebetweenfailure,MTBF主題事務(wù)專家subjectmatterexpert,SME緞帶式混合機ribbonblender在線清洗cleaninplace，CIP錐型混合機conicalscrewblender輥壓制粒rollercompaction壓片能力compressibility導(dǎo)流管wurstercolumn中間過程控制inprocesscontrol,IPC物料桶intermediarybulkcontainers,IBCs關(guān)鍵工藝參數(shù)criticalprocessparameters,CPP工藝驗證processvalidation前驗證/前瞻性驗證prospectivevalidation同步驗證concurrentvalidation回顧性驗證retrospectivevalidation個人防護設(shè)備personalprotectiveequipment,PPE職業(yè)暴露限值occupationalexposurelimit,OEL職業(yè)暴露等級occupationalexposurebands,OEB口服固體制劑oralsoliddosage,OSD人流/物流personflow/materialflow藥物活性成分activepharmaceuticalingredients，API中間體intermediateproducts需氧細菌aerobicbacteria安瓿瓶ampoule厭氧細菌anaerobicbacteria空態(tài)潔凈區(qū)as-bulitcleanroom無菌生產(chǎn)asepticprocessing靜態(tài)2七-rest滅菌釜‘a(chǎn)utoclave微生物污染水平bioburden生物指示劑biologicalindicators吹灌封blow/fill/seal玻璃瓶bottle軋蓋capping潔凈區(qū)cleanarea潔凈級別cleanlinesslevel在線清洗cleaninplace,CIP潔凈室cleanroom菌洛數(shù)colonyformingunit,CFU組分component壓縮氣體compressedgas污染contaminant關(guān)鍵區(qū)域criticalareas關(guān)鍵外表criticalsurfaces菌種保臧culturepreservation脫水培養(yǎng)基dehydratedmedia隧道烘箱depyrogenatingtunnel消毒disinfection直接接種法directinoculationmethod干熱滅菌法dryheatsterilization染色浴dyebath混懸劑emulsion毒素endotoxin環(huán)氧乙烷ethyleneoxide面罩facemask灌裝filling硫乙醇酸鹽流體培養(yǎng)基fluidthioglycollatemedium詞匯表脆碎性friability真菌fungi著裝gowning熱分布heatdistribution熱穿透heatpenetration供熱通風(fēng)與空氣調(diào)節(jié)heating,ventilationandairconditioning,HVAC高效空氣過濾器highefficiencyparticulateairfilter,HEPA高壓電檢漏highfrequencycracktest高風(fēng)險操作highriskoperations疏水性hydrophobicbehaviour衛(wèi)生hygiene完整性integrity干預(yù)intervention輻射irradiation隔離器isolator層流laminarflow緩沖容器levelvessel培養(yǎng)基灌裝mediafilling微生物學(xué)microbiology微生物microorganism含多種溶劑的混合溶劑mixturesofvarioussolvents改良馬丁培養(yǎng)基modifiedMartinmedium監(jiān)測計劃monitoringprogram陰性對照negativecontrol軟膏劑ointments眼用制劑ophthalmicpreparation參數(shù)放彳丁parametricrelease未完全密封狀態(tài)partiallyclosedstate微粒particulate懸浮粒子particle增塑劑plasticizer日允許接觸劑量permitteddailyexposure,PDE極化過濾器polarisationfilter陽性對照positivecontrol包裝材料primarypackagematerials非無菌單兀的概率probabilityofnon-sterileunit,PNSU無菌工藝模擬試驗processstimulationtest保護性眼罩protectivegoggle熱原pyrogen無菌藥品Asepticdrug快速傳遞口rapidtransferports,RTPs艮口滅菌膠塞readyforsterilizationstoppers,RFS即用膠塞readyforusestoppers,RFU回收測試recoverytest冗余過濾redundantfiltration儲料罐r(nóng)eservoir限制進出隔離系統(tǒng)restrictedaccessbarriersystem,RARS清潔sanitization沉降碟法settleplates區(qū)域隔離sit-over大豆胰蛋白胨培養(yǎng)基soybean-caseindigestmedium質(zhì)量標準specifications孢子spore殺孢子劑sporicidal標準操作規(guī)程standardoperationprocedure,SOP無菌保證水平sterilityassurancelevel,SAL無菌檢查sterilitytest無菌藥品sterilepharmaceuticalproducts滅菌sterilizationSIP在線滅菌sterilizationinplace,SIP儲液罐storagevessel外表取樣法surfacesampling最終滅菌terminalsterilization總有機碳totalorganiccarbon,T透明度transparency紊流turbulence單向流unidirectionalairflow用戶需求標準userrequirementspecifications，URS西林瓶vial目檢visualinspection定量空氣法volumetricair稱量箱weighingboxes最差條件worstcase根本設(shè)計basicdesign按批次生產(chǎn)batch-basedproduction混合blending混批blendingbatches階段性生產(chǎn)campaign-basedproduction清場。leananceorsitecleaning在線清洗cleaninplace,CIP概念設(shè)計conceptdesign連續(xù)生產(chǎn)continuousproduction委托生產(chǎn)contractmanufacture委托檢驗contractanalysis關(guān)鍵偏差criticaldeviation關(guān)鍵工藝參數(shù)criticalprocessparameter,CPP關(guān)鍵操作步驟criticalprocessingstep交叉污染crosscontamination設(shè)計確認designqualification，DQ詳細設(shè)計detaileddesign設(shè)備使用日志equipmentlogbook預(yù)期收率expectedyield有效期expirydate良好工程實踐goodengineeringpractice,GEPC存期holdingtime雜質(zhì)檔案impurityprofile過程控制in_processcontrol過程取樣in_processsampling安裝確認installationqualification,IQ中間體intermediate維護根本實踐maintenancebasicpractice維護最正確實踐maintenancebestpractice,維護良好實踐maintenancegoodpractice維護計劃maintenanceplan維護管理程序maintenanceprogram主細胞庫mastercellbank，MCB主生產(chǎn)和控制記錄masterproductionandcontrolrecord,MP&CR不合格non-conformance運行確認operationqualification,OQ原料藥續(xù)表超標。誕ofspecification,OOS性能確認performancequalification,