药品生产常用词汇中英文对照表.docx

药品生产常用词汇中英文对照表环境，健康，安全environment，health,safety，EHS质量风险管理qualityriskmanagement,QRM风险评估riskassessment风险控制riskcontrol事先危害分析preliminaryhazardanalysis,PHA失败模式效果分析failuremodeeffectsanalysis，FMEA危害分析及主要控制点hazardanalysisandcriticalcontrolpoints,HACCP过失树分析faulttreeanalysis,FTA两次失败之间的平均时间meantimebetweenfailure,MTBF主题事务专家subjectmatterexpert,SME缎带式混合机ribbonblender清洗cleaninplace，CIP锥型混合机conicalscrewblender辊压制粒rollercompaction压片能力compressibility导流管wurstercolumn中间过程控制inprocesscontrol,IPC物料桶intermediarybulkcontainers,IBCs关键工艺参数criticalprocessparameters,CPP工艺验证processvalidation前验证/前瞻性验证prospectivevalidation同步验证concurrentvalidation回顾性验证retrospectivevalidation个人防护设备personalprotectiveequipment,PPE职业暴露限值occupationalexposurelimit,OEL职业暴露等级occupationalexposurebands,OEB口服固体制剂oralsoliddosage,OSD人流/物流personflow/materialflow药物活性成分activepharmaceuticalingredients，API中间体intermediateproducts需氧细菌aerobicbacteria安瓿瓶ampoule厌氧细菌anaerobicbacteria空态洁净区as-bulitcleanroom无菌生产asepticprocessing静态at-rest灭菌釜‘autoclave微生物污染水平bioburden生物指示剂biologicalindicators吹灌封blow/fill/seal玻璃瓶bottle洁净区cleanarea洁净级别cleanlinesslevel清洗cleaninplace,CIP洁净室cleanroom菌落数colonyformingunit,CFU组分component压缩气体compressedgas污染contaminant关键区域criticalareas关键表面criticalsurfaces菌种保藏culturepreservation脱水培养基dehydratedmedia隧道烘箱depyrogenatingtunnel消毒disinfection直接接种法directinoculationmethod干热灭菌法dryheatsterilization染色浴dyebath混悬剂emulsion内毒素endotoxin环氧乙烷ethyleneoxide面罩facemask硫乙醇酸盐流体培养基fluidthioglycollatemedium词汇表脆碎性friability真菌fungi着装gowning热分布heatdistribution热穿透heatpenetration供热通风与空气调节heating,ventilationandairconditioning,HVAC高效空气过滤器highefficiencyparticulateairfilter,HEPA高压电检漏highfrequencycracktest高风险操作highriskoperations疏水性hydrophobicbehaviour卫生hygiene完整性integrity干预intervention辐射irradiation隔离器isolator层流laminarflow缓冲容器levelvessel微生物学microbiology微生物microorganism含多种溶剂的混合溶剂mixturesofvarioussolvents改良马丁培养基modifiedMartinmedium监测计划monitoringprogram阴性对照negativecontrol软膏剂ointments眼用制剂ophthalmicpreparation参数放行parametricrelease未完全密封状态partiallyclosedstate微粒particulate悬浮粒子particle增塑剂plasticizer日允许接触剂量permitteddailyexposure,PDE极化过滤器polarisationfilter阳性对照positivecontrol内包装材料primarypackagematerials非无菌单元的概率probabilityofnon-sterileunit,PNSU无菌工艺模拟试验processstimulationtest保护性眼罩protectivegoggle热原pyrogen无菌药品Asepticdrug快速传递口rapidtransferports,RTPs即灭菌胶塞readyforsterilizationstoppers，RFS即用胶塞readyforusestoppers,RFU回收测试recoverytest冗余过滤redundantfiltration储料罐reservoir限制进出隔离系统restrictedaccessbarriersystem,RARS清洁sanitization沉降碟法settleplates区域隔离sit-over大豆胰蛋白胨培养基soybean-caseindigestmedium质量标准specifications孢子spore杀孢子剂sporicidal标准操作规程standardoperationprocedure,SOP无菌保证水平sterilityassurancelevel,SAL无菌检查sterilitytest无菌药品sterilepharmaceuticalproducts灭菌sterilization灭菌sterilizationinplace,SIP储液罐storagevessel最终灭菌terminalsterilization总有机碳totalorganiccarbon,TOC透明度transparency紊流turbulence单向流unidirectionalairflowURS用户需求标准userrequirementspecifications西林瓶vial目检visualinspection定量空气法volumetricair称量箱weighingboxes最差条件worstcase基本设计basicdesign按批次生产batch-basedproduction混合blending混批blendingbatches阶段性生产campaign-basedproduction清场cleananceorsitecleaning清洗cleaninplace,CIP概念设计conceptdesign连续生产continuousproduction委托生产contractmanufacture委托检验contractanalysis关键偏差criticaldeviation关键工艺参数criticalprocessparameter,CPP关键操作步骤criticalprocessingstep交叉污染crosscontamination设计确认designqualification，DQ详细设计detaileddesign设备使用日志equipmentlogbook预期收率expectedyield有效期expirydate良好工程实践goodengineeringpractice,GEPC存期holdingtime杂质档案impurityprofile过程控制in_processcontrol过程取样in_processsampling安装确认installationqualification,IQ中间体intermediate维护基本实践maintenancebasicpractice维护最佳实践maintenancebestpractice,维护良好实践maintenancegoodpractice维护计划maintenanceplan维护管理程序maintenanceprogram主细胞库mastercellbank，MCB主生产和控制记录masterproductionandcontrolrecord,MP&CR不合格non-conformance运行确认operationqualification,OQ原料药续表超标outofspecification,OOS性能确认performancequalification,PQ原始细胞库preliminarycellbank，PCB质量协.qualityagreement质量审核qualityreview快速传递接口rapidtransferport，RTP物料平衡reconciliation拒收reject复验期retestdate环境、健康及安全safety,environment,health,EHS半连续生产semi-continuousproduction质量标准。