制药英文缩写表.docVIP

常见词汇缩写英文缩写英文全称中文AAC Air Conditioner空调ADR Adverse Drug Reaction药品不良反应AHUAir Handling Unit空气处理单元APIActive Pharmaceutical Ingredient活性药物组分（原料药）ANDAAbbreviated New Drug Application简略新药申请AQL??Acceptable Quality Level可接受质量水平ASM Active Substance Manufacturer活性物质生产商ASMEAmerican Society of Mechanical Engineers 美国机械工程师协会BBMSBuilding Monitoring System 楼宇监测系统BOM??? Bill of Material物料清单BPBritish Pharmacopoeia英国药典BPC?Bulk pharmaceutical Chemicals?原料药CCAPA Corrective and Preventive Action纠正预防措施CCAComponent Criticality Assessment组件关键性评估CEPCertificate of Suitability for European Pharmacopeia欧洲药典适用性证书CFRCode of Federal Regulations美国联邦法规CFU?? Colony Forming Unit??菌落形成单位CHWChilled Water冷冻水CIP? Clean in Place??在线清洗CIPCCritical In-Process Control关键中间控制点CNCControlled Non-Classified 控制但未分级COA Certificate of Analysis分析报告单COMCommissioning试车COPClean out of Place?离线清洗CPPCritical Process Parameter关键工艺参数CQACritical Quality Attribute关键质量属性CROContract Research Organization合同研究组织（外包）CSComputerized System计算机系统CTD Common Technical Document通用技术文件CV Cleaning Validation清洁验证CMCChemistry Manufacturing Control化学制造控制DDMFDrug Master File药物主文件DSDesign Specification 设计说明EEDQMEuropean Directorate for the Quality of Medicines HealthCare欧洲药品与健康质量理事会EHSEnvironment, Health and Safety 环境、健康和安全EMAEuropean Medicines Agency欧洲药监局EP European Pharmacopoeia欧洲药典FFATFactory Acceptance Test 出厂验收测试FDAFOOD AND DRUG ADMINISTRATION（美国）食品药品监督管理局FDSFunction Design Specification功能设计说明FEMAFailure Mode and Effects Analysis 失效模式及后果分析FFUFan Filter Unit风机过滤单元FMSFacility Monitoring System设施监控系统FSFunctional Specification功能说明GGAMPGood Automated Manufacturing Practice优良自动化生产管理规范GCP Good Clinical Practice药品临床研究管理规范GEPGood Engineering Practice优良工程管理规范GLP Good Laboratory Practice药品临床前安全性研究质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范GSP Good Supply Practice药品经营质量管理规范HHACCPHazard Analysis and Critical Control Point危害分析和关键环节控制点HEPAHigh Efficiency Particulate Air高效空气过滤器HMIHuman Machine Interface 人机界面HVAC? Heating Ventilation Air Conditioning?供热