制药工艺验证实施手册缩略语.docx

术语/缩略语英文全拼中文AHUAir Handing Unit空调机组AOACAssociation of Official Analytical Chemists美国公职化学家协会AMVAnalytical Method Validation分析方法验证API Active Pharmaceutical Ingredient 药物活性成分ASME American Society of Mechanical Engineers 美国机械工程学会ASME BPE American Society of Mechanical Engineers Bioprocessing Equipment 美国机械工程/生物工程设备学会ASTMAmerican Society for Testing and Materials 美国材料与试验协会BDBowie-Dick布维-狄克BIBiological indicator生物指示剂BMSBuilding Management System楼宇控制系统CAPA Corrective and Preventative Action 纠正和预防措施CCAComponent Criticality Assessment部件关键性评估CCP Critical Control Point 关键控制点CDCycle Development程序开发CEHTClean equipment hold time干净设备保留时间CFR Code For Federal Regulations美国联邦法规CFUColony Forming Unit菌落形成单位cGMPCurrent Good Manufacturing Practice 现行药品生产质量管理规范CHOChinese Hamster Ovary中国仓鼠卵巢细胞CIPClean In Place在线清洗ChPChinese Pharmacopeia中国药典Cp/CpkProcess Capability Index 工序能力指数CPPCritical Process Parameter关键工艺参数CQACritical Quality Attribute关键质量属性CSVComputer System Validation计算机系统验证CVPCleaning Validation Plan清洁验证计划DCSDistributed Control System 分布式控制系统DDSDetailed Design Specification详细设计说明DEHTDirty equipment hold time脏设备保留时间DNADeoxyribonucleic acid脱氧核糖核酸DOEDesign of Experiment 实验设计DOPDioctyl Phthalate（Or Equivalent，I.E., Dispersed Oil Particulate）邻苯二甲酸二辛脂（或等同品，例如分散油颗粒）DQDesign Qualification设计确认DSDesign Specification设计说明ED 5050% Effective Dose半数有效量EDI Electrodeionization Deionization (US Filter) 电级法去离子（美国滤材）EHSEnvironment Health Safety环境健康安全ELISAEnzyme-Linked Immuno Sorbent Assay酶联免疫吸附测定EMAEuropean Medicines Agenc欧洲药品管理局EMSEnvironmental Monitoring System环境监测系统EPEuropean Pharmacopoeia欧洲药典EPA Environmental Protection Agency 美国环境保护署ERPEnterprise Resource Planning企业资源计划ETOPEngineering turnover packages工程交付包EUEuropean Union欧盟FAT Factory Acceptance Testing 工厂验收测试FDAFood and Drug Administration美国食品与药品监督管理局FDS Functional Design Specification 功能设计说明FMEA Failure Modes And Effects Analysis失效模式和影响分析FSFunction Specification功能说明FTA Fault Tree Analysis 故障树分析FQCPField Quality Control Plan现场质量控制计划GAMPGood Aut