洁净词汇中英文对照.doc

净化专业词汇中英文对照 Page 7 of 7GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划（PIC/S） PIC的权威翻译：药品生产检查相互承认公约API(Active Pharmaceutical Ingredient) 原料药 又称：活性药物组分Air Lock 气闸 Authorized Person 授权人Batch/Lot 批次 Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area洁净区；Consignment（Delivery）托销药品。FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请TREATMENT IND：研究中的新药用于治疗 ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER：DMF持有者 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规 PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PREscriptION DRUG：处方药OTC DRUG（OVERTHECOUNTER DRUG）：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of Analysis C of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member State CMS每个成员国COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organization CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical documentCTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine Association ELA Established License ApplicationEMEA European Medicines Evaluation AgencyEMEA （European Agency for the Evaluation of Medicinal Products） 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug AdministrationFinal Evaluation Report (FER)Free Sale Certificates (FSCs)GCP Good Clinical Practice GCP药品临床研究管理规范GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing Practice GMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSAs Medicines Advisory Committee (MAC)IB Investigators Brochure ICH International Conference for Harmonization IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonization (ICH) IPC In Process Control IRB Institutional Review Board LICENCE HOLDERMA Marketing Authorization MAA Marketing Authorization Application MAA上市申请MAH Marketing Authorization Holder MAH 销售许可持有者MCA Medicines Control Agency MHW Ministry of Health and Welfare (Japan) MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE New Chemical Entity NDA New Drug Application New Chemical Entities (NCEs)New Drug Applications (NDAs)NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over the Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product License POM Prescription Only Medicine PRODUCT OWNERPSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP （STANDARD OPERATION PROCEDURE） 标准运作程序SPC Summary of Product Characteristics Therapeutic Goods Administration (TGA)USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products CommitteeAAA Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemicals 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unit 菌落形成单位DMF Drug Master File 药品管理档案CDER Center for Drug Evaluation and Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Inspector 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Administration 管制药品管理DS documentation System 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreement on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Good Retail Practice 药品零售业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Good Validation Practice 验证管理规范GUP Good Use Practice 药品使用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO International Organization for Standardization 国际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Production File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Management Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Total Quality Control 全面质量管理USA United States Pharmacopoeia 美国药典质检专业术语1. 认可的实验室 accredited laboratory2. 提前装运通知 advanced shipment notification (ASN)3. 基准确定 benchmarking4. 经营计划 business plan5. 计算机辅助设计 computer aided design (CAD)6. 计算机辅助工程 computer aided engineering (CAE)7. 校准 calibration8. 应急计划 contingency plan9. 持续改进计划/方案 continuous improvement plan/program10. 合同 contract11. 控制计划 control plan12. 纠正措施计划 corrective action plan13. 不良质量成本 cost of poor quality14. 横向职能方法 cross-functional approach15. 装配性设计 design for assembly (DFA)16. 实验设计 design of experiment (DOE)17. 设计纪录 design record18. 设计责任供方 design-responsible suppliers19. 文件 documentation20. 安全关注 due care21. 设备 equipment22. 工程批准的授权 engineering approved authorization23. 执行职责 executive responsibility24. 有限元分析 finite element analysis (FEA)25. 可行性 feasibility26. 先进先出 first in first out (FIFO)27. 失效模式及后果分析 failure mode and effects analysis (FMEA)28. 功能验证 functional verification29. 几何尺寸与公差 geometric dimensioning & tolerancing (GD&T)30. 作业指导书 job instruction31. 实验室 laboratory32. 实验室范围 laboratory scope33. 末件比较 last off part comparison34. 全尺寸检验 layout inspection35. 防错 mistake proofing36. 多方论证方法 multi-disciplinary approach37. 运行业绩 operational performance38. 预见性维护 predictive maintenance39. 超额运费 premium freight40. 预防性维护 preventive maintenance41. 解决问题 problem solving42. 程序 procedures43. 过程审核 process audit44. 过程流程图 process flow diagram flow chart45. 产品 product46. 产品实现 product realization47. 产品审核 product audit48. 项目管理 project management49. 质量功能展开 quality function deployment (QFD)50. 质量手册 quality manual51. 反应计划 reaction plan52. 外部场所 remote location53. 重复性和再现性研究 repeatability and reproducibility studies54. 现场 site55. 特殊特性 special characteristics56. 分承包方 subcontractor57. 分承包方的开发 subcontractor development58. 供方 supplier59. 投标 tender60. 工具/工装 tool/tooling更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning Tools Room清洗室 Cleaning Room模具室 Dies Room内包装室 Immediate Package Room安全门 Emergency Door外包清室Outer Package Removing Room存料间Storage Room of Raw Materials粉碎室 Pulverizing Room备料室 Materials Preparing Room硬胶室 Hard Capsules Filling Room软胶室 Soft Capsules Room制粒干燥室Granulating and Drying Room总混间 Blending Room中间站 Intermediate Station压片室Tablets Room Compression Room包衣室 Coating Room配浆间 Coating Mixture Preparing Room铝塑包装间Packing Room传递窗 Transferring Window外包装室 Outer Packing Room蒸馏水室 Water Purifying Room质检室 Quality Control Room浓配室 Concentrated Solution Room稀配室 Diluted Solution Room灌封室Filling and Sealing Room存瓶室 Ampul Storage Room洗瓶室 Ampul Cleaning Room灭菌间 Sterilizing Room灯检室 Light Inspection Room粉针室 Lyophilized Sterile Powder Room冷冻干燥机 LyophilizerUrine Analyzer 尿液分析仪blood sugar（glucose ） analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle采血针needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite 气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机暖通专业词汇中英文对照(一）ahu air hundling unit 空调箱air conditioning load空调负荷air distribution气流组织air handling unit 空气处理单元air shower 风淋室air wide pre.drop空气侧压降aluninum accessaries in clean room 洁净室安装铝材as-completed drawing 修改竣工图ayout 设计图blass stop valve 铜闸阀canvas connecting termingal 帆布接头centigrade scale 摄氏温度chiller accessaries 水冷柜机排水及配料chiller asembly 水冷柜机安装工费chiller unit 水冷柜机基础clean bench 净化工作台clean class 洁净度clean room 洁净室 无尘室correction factor修正系数dcc dry coll units 干盘管district cooling 区域供冷direct return system异程式系统displacement ventilation置换通风drawn No.图号elevation立面图entering air temp进风温度entering water temp进水温度fahrenheit scale 华氏温度fan coil unit 风机盘管ffu fan filter units 风扇过滤网组final 施工图flow velocity 流速fresh air supply 新风供给fresh air unit 新风处理单元ground source heat pump地源热泵gross weight 毛重heating ventilating and air conditioning 供热通风与空气调节hepa high efficiency pariculate air 高效过滤网high efficiency particulate air filters高效空气过滤器 horizontal series type水平串联式hot water supply system生活热水系统humidity 湿度hydraulic calculation水力计算isometric drawing轴测图leaving air temp 出风温度leaving water temp出水温度lood vacuum pump中央集尘泵mau make up air hundling unit schedule 外气空调箱natural smoke exhausting自然排烟net weight 净重noise reduction消声nominal diameter 公称直径oil-burning boiler燃油锅炉one way stop peturn valve 单向止回阀operation energy consumption运行能耗pass box 传递箱particle sizing and counting method 计径计数法Piping accessaries 水系统辅材piping asembly 配管工费plan 平面图rac recirculation air cabinet unit schedule循环组合空调单元ratio controller 比例调节器ratio flow control 流量比例控制ratio gear 变速轮 ratio meter 比率计rational 合理性的，合法的；有理解能力的rationale （基本）原理；原理的阐述rationality 有理性，合理性rationalization proposal 合理化建义ratio of compression 压缩比ratio of expansion 膨胀比ratio of run-off 径流系数ratio of slope 坡度ratio of specific heat 比热比raw 生的，原状的，粗的；未加工的raw coal 原煤 raw cotton 原棉raw crude producer gas 未净化的发生炉煤气raw data 原始数据raw fuel stock 粗燃料油raw gas 未净化的气体real gas 实际气体realignment 重新排列，改组；重新定线realm 区域，范围，领域real work 实际工作ream 铰孔，扩孔rear 后部，背面，后部的rear arch 后拱rear axle 后轴rear-fired boiler 后燃烧锅炉rear pass 后烟道rearrange 调整；重新安排布置rearrangement 调整，整顿；重新排列布置reason 理由，原因；推理reasonable 合理的，适当的reassembly 重新装配reaumur 列氏温度计reblading 重装叶片，修复叶片recalibration 重新校准刻度recapture 重新利用，恢复recarbonation 再碳化作用recast 另算；重作；重铸receiving basin 蓄水池receiving tank 贮槽recentralizing 恢复到中心位置；重定中心；再集中receptacle 插座孔；容器reception of heat 吸热recessed radiator 壁龛内散热器，暗装散热器recharge well 回灌井reciprocal 倒数；相互的，相反的，住复的reciprocal action 反复作用reciprocal com