药品常用英语缩写
制药行业常用英语词汇(缩写、中英文对照)
制药行业常用英语词汇（缩写、中英文对照）制药行业常用英语词汇（缩写、中英文对照）序号中文英文及缩写 1 药品生产质量管理规范 GMP：GoodManufacturingPractice 2 国家食品与药品监督管理局 State Food and Drug Administration 3 总则 GeneralProvisions 4 《中华人民共和国药品管理法》 the DrugAdministration Law of the People"s Republic of China 5 制剂Preparation 6 原料药 API: Active PharmaceuticalIngredient 7 成品finished goods 8 工序 process 9 机构与人员 organization and personnel 10 专业知识 professional knowledge 11 生产经验 production e_perience 12 组织能力 organizational skill 13 技术人员 technical staff 14 实施implementation 15 药品生产 pharmaceutical manufacturing 16 质量管理quality management 17 质量检验 quality inspection 18 专业技术培训professional and technicaltraining 19 基础理论知识 basic theoreticalknowledge 20 实际操作技能 practical operationskills 21 高生物活性 highly potent 22 高毒性 high to_icity 23 污染 contamination 24 考核评估 assessment25 厂房与设施 buildings and facilities 26 生产环境 production environment 27 空气洁净级别 clean air level 28 昆虫 insect 29 洁净室（区）clean room(area) 30 光滑 smooth 31 无裂缝 no cracks 32 无颗粒物脱落no particle shedding 33 耐受 endure 34 消毒 disinfection 35 无菌 sterile 36 交界处 junction, joint 37 弧形 arc 38 灰尘积聚 dues accumulation 39 储存区 store area 40 生产规模 production scale 41 设备 equipment 42 物料material 43 中间产品 intermediate product 44 待验品 quarantined material 45 交叉污染 cross-contamination 46 管道 pipeline, ductwork 47 风口 tuber 48 公用设施, 公用工程 utilities of publicservice 49 照明 lighting 50 照度 illumination 51 应急紧急情况 emergency 52 净化 purification, clean 53 微生物, 微生物学, 微生物 micro-organism,microbiology,microbiologic的 54 监测 monitoring 55 记录 record 56 天棚天花板 ceiling, roof 57 密封 seal 58 静压差 Static DifferentialPressure 59 温度 temperature 60 相对湿度 RH: Relative Humidity 61 低漏地漏 floor drainer 62 青霉素penicillin 63 分装室 separating room, fillingroom 64 相对负压 relative negativepressure 65 废气 waste gas,e_hausted air 66 β－内酰胺结构类药品 β-Lactasestructure drug, drugs of β-Lactic group 67 避孕药品 contraceptives 68 激素类 hormone 69 抗肿瘤类 anti-tumor, oncology 70 放射性药品 Radiopharmaceuticals 71 包装 packing, package 72 循环使用recycling 73 微粒 particles 74 辐射 radiation, irradiation 75 细菌bacteria 76 病毒 virus 77 细胞 cell 78 脱毒前后 pre and postdeto_ification 79 活疫苗与灭活疫苗 activevaccine/inactivatedvaccine 80 人血液制品 blood products 81 预防制品prevention products82 灌装 filling 83 中药 Chinesetraditional medicines 84 前处理pretreatment 85 提取 e_traction 86 浓缩 concentration 87 动物脏器viscera of animal,organ ofanimal 88 蒸、炒、炙、煅 ing, frying,sunburn, testing 89 炮制concocted 90 通风 ventilation 91 除烟 smoke removal 92 除尘 dust removal 93 降温设施 temperature-reducingestablishment,cooling 94 筛选 screening, sift 95 切片 slicing 96 粉碎 grinding 97 压缩空气 pressed air 98 惰性气体 noble gas 99 取样 Sling 100 称量室weighing room, dispensingroom 中药标本 Chinese herbalsle,e_emplar of TCM 102 检定鉴定 verification, identification 103 同位素 Isoe 104 设备 equipment 105 选型 model/type selection 106 耐腐蚀anticorrosion 107 吸附 adsorption, absorption 108 润滑剂, 润滑 lubricant, lubricate 109 冷却剂 coolant 110 流向 flow direction111 纯化水 PW: Purified Water 112 注射用水 WFI: Water for Injection 113 滋生 breeding 114 储罐 tank 115 死角 neglected portion 116 盲管blind pipe 117 纤维 fiber 118 疏水性 hydrophobicity 119 仪表instrumentation 120 量具 measuring tool 121 衡器 weighing instrument 122 精密度 precision 123 维修 maintenance 124 不合格 disqualified reject 125 物料 material 126 购买 purchasing 127 发放 releasing 128 产地 origin 129 入库 loading 130 固体 solid 131 液体 liquid 132 挥发性 volatile 133 净药材 medicine, TCM 134 麻醉药品 narcotics 135 精神药品 psychotropic drug 136 易燃 bustible 137 易爆 e_plosive 138 验收 acceptance 139 使用说明书instruction140 标签 label 141 卫生, 清洁/消毒 sanitation 142 车间, 辅房workshop 143 间隔时间 time interval 144 清洁剂 detergent 145 消毒剂disinfectant 146 废弃物 wastes 147 更衣室 changing room 148 工作服, work clothes 149 颗粒性物质, 颗粒剂 granules 150 耐药菌株 drug-resistantstrain 151 传染病 infectiousdisease 152 皮肤病 dermatitis 153 验证verification, validation 154 确认 qualification 155 安装 installation156 运行 running operation 157 性能 performance 158 原辅料 raw material and incipient 159 文件 document 160 投诉 plaint 161 报废 reject 162 品名product name 163 处方 preion, formula 164 技术参数 technicalparameter165 容器 container 166 半成品 semi-finished product,intermediate 167 申请 lication 168 稳定性 stability169 起草 draft 170 生产管理 production management,manufacturing control.171 事故 accident 172 混淆 mi_-up 173 喷雾 spray 174 合格证certificate 175 清场 clearance 176 质量管理 quality management 177 内控internal control,on-line test 178 滴定液 tartan 179 培养基 medium 180 有效期 validity, e_piry date,shelf life 181 产品销售与收回 product sales andrecovery/recall 182 投诉与不良反应报告 plaints and adversereaction 自检self-inspection 184 附则 schedule endi_ 185 平衡 balance 186 饮用水drinking water, potablewater 187 蒸馏法 distillation 188 离子交换法 ion e_change 189 反渗透法 RO: Reverse Osmosis 190 附加剂添加剂 additives 191 滞留 stranded resort 192 批 batch, lot 193 组分, 组成 ponent 194 无纤维脱落的过滤器 non-fiber-releasingfilter 195 活性成份 Active Ingredient 196 非活性成份 Inactive ingredient 197 中间产品 in-processproduct,intermediate product198 批号 batch number 199 药用物料 medicated feed 20__药用预混合料 medicated premi_ 201 质量控制部门 Quality control department 202 理论产量 Theoretical yield 203 实际产量 Actual yield 204 比率 Percentage, rate 205 验收标准可接受标准 Acceptance criteria 206 代表性样品 Representative sle 207 微粒状的 particulate 208 污染物contaminant 209 石棉 asbestos 210 诊断 diagnosis 211 缓解 mitigation 212 化学变化 chemical change 213 组分 ingredient, ponent 214 制备 fabricate preparation 215 复合 pound 216 混合 blend 217 加工 processing 218 浓度concentration 219 单位剂量 unit dose 220 药品包装容器 drug product containers 221 密封件, 封盖 closure 222 效价 Titer 223 纯度 purity 224 规格 strength 225 监督 supervise, monitor 226 实验室 laboratory 227 无菌操作 aseptic operation,sterileoperation 228 层流 laminar flow 229 湍流 turbulent air flow 230 空气过滤 air filtration 231 空气加热 air heating 232 预过滤器 profiler 233 排气系统 e_haust system 234 管件 plumbing 235 虹吸倒流 back-siphon age 236 污水 sewage 237 废料 refuse 238 盥洗设备 toilet facilities 239 空气干燥器 air drier 240 垃圾 trash 241 有机废料 organic waste 242 杀鼠剂rodenticides 243 杀昆虫剂 insecticides 244 杀真菌剂 fungicides 245 熏蒸剂 fumigating reagents 246 去垢剂 cleaning agents 247 消毒剂 sanitizing agents 248 滂沱剂 lubricant 249 自动化设备 automatic, mechanical,or electronic equipment 250 微型胶卷 microfilm 251 注射剂 injection 252 灭菌设备 sterilization equipment 253 无菌取样技术 aseptic sling techniques 254 显微镜 microscope 255 热, 内毒素 pyrogen, endoto_in 256 偏差 deviation 257 变更 change control 258 进料 charge-in 259 项目代码 item code 260 鉴别 identify 261 片剂 tablet 262 胶囊 capsule 263 颗粒剂 granule 264 溶解时间溶出时间 dissolution time 265 澄明度clarity 266 隔离系统 quarantinesystem, isolation system 267 返工reprocessing 268 发放 issuance, release 269 非处方药 OTC:over-the-counter 270 处方药 preed medicine 271 皮肤科药、牙粉、胰岛素、喉片dermatological,dentifrice,insulin, or throat lozenge product 272 保险包装 ter-resistant package 273 明胶硬胶囊 hard gelatin capsule 274 顺势治疗homeopathic 275 入库 warehousing 276 变质 deteriorate 277 准确性accuracy 278 灵敏性 sensitivity 279 特异性 specificity 280 重复性reproducibility, repeatability 281 变应原提取物 allergenic e_tracts 282 眼膏 ophthalmic ointment 283 粗糙或磨蚀物质 harsh or abrasivesubstances 284 控释制剂 controlled-releasedosage form 285 实验动物 laboratory animals 286 供应商 Supplier 287 光谱 spectrum 288 测量单位 units of measure 289 换算系数 conversion factors 290 试剂 reagent 291 安慰剂placebo 292 明确地 e_plicitly 293 取代 supersede 294 溶液 solution 295 批准 roval 296 (美国)食品药品监督管理局 FDA: Food and DrugAdministration 297 标准操作程序 SOP: StandardOperatingProcedure 298 质量保证 QA: Quality Assurance 299 质量控制QC:Quality Control 300 批生产记录 BPR: Batch ProductionRecord 301 批检验记录 BAR: Batch AnalysisRecord 302 工艺规程 PP: Process Procedure 303 健康,安全,环保 EHS: Environment,Health andSafe 304 美国联邦法规 CFR: Code of FederalRegulation 305 美国药典USP: The UnitedStatesPharmacopeia 306 欧洲药典 EP: European pharmacopeia 307 英国药典 BP: British pharmacopeia 308 药物主文件 DMF: Drug Master File 309 验证主计划 VMP: Validation MasterPlan 310 验证方案 VP: Validation Protocol 311 验证报告 : Validation Report 312 安装确认 IQ: Installation Qualification313 运行确认 OQ: Operation Qualification 314 性能确认 PQ: Performance Qualification 315 超出标准(限度) OOS: Out of Specification 316 冻干产品 freeze-dry product,lyophilizated product 317 工厂主述文件SMF: Site Master File。
药品常用英语缩写1
《GMP英语词汇及缩写》第一部分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 Ingrediet) 原料药又称：活性药物组分AirLock 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；Consignmecnt（Delivery）托销药品。
FDA（FOOD AND DRUG ADMINISTRA TION）：（美国）食品药品管理局IND（INVESTIGA TIONAL 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 APPLICA TION）：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BA TCH PRODUCTION：批量生产；分批生产BA TCH 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（OVER—THE—COUNTER DRUG）：非处方药第二部分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 ApplicationANOV A 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 AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence 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 PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products Committee第三部分常用缩略语A．A．A 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 Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd 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 Insepctor 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 Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GA TT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 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 Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HV AC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction 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 Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典。
药品常用英语缩写
《GMP英语词汇及缩写》第一部分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 Ingrediet) 原料药又称：活性药物组分AirLock 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；Consignmecnt（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（OVER—THE—COUNTER DRUG）：非处方药第二部分 GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry ADR 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 AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPA EDQM (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 AssociationELA Established Licence 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 PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 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 ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great Britain Ph Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products Committee第三部分常用缩略语A．A．A 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 Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd 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 Insepctor 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 Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 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 Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction 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 Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典欢迎您的下载，资料仅供参考！致力为企业和个人提供合同协议，策划案计划书，学习资料等等打造全网一站式需求。
药品常用英语缩写
《GMP英语词汇及缩写》第一部分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 Ingrediet) 原料药又称：活性药物组分AirLock 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；Consignmecnt（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（OVER—THE—COUNTER DRUG）：非处方药第二部分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 AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence 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 PracticeGCP药品临床研究管理规GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规GMP Good Manufacturing PracticeGMP 药品生产质量管理规GSP药品销售管理规Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products Committee第三部分常用缩略语A．A．A 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 Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd 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 Insepctor 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 Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规GCP Good Clinical Practice 药品临床实验管理规GLP Good Laboratory Practice 实验室管理规GSP Good Supply Practice 药品商业质量规GRP Gook RaTAIL Practice 药品零业质量管理规GAP Good Agriculture Practice 药材生产管理规GVP Gook Validation Prctice 验证管理规GUP Gook Use Practice 药品重用规HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction 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 Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典。
药品注册用英语,常见药品注册用英语缩写,FDA药品审评相关术语
药品注册用英语CEP：欧洲药典适应性证书certificate of suitability to monograph of European Pharmacopoeia。
是欧洲药典所收载的原料药的一种认证程序，用以确定原料药的质量可以用欧洲药典的方法加以控制。
这一程序适用于生产的和提取的有机或无机物质以及发酵生产的非直接基因产品。
DMF：Drug master File美国药物主文件档案。
是指提交给FDA的用于提供关于人用药品的生产设备、工艺或生产、工艺处理、包装和储存中使用的物料的详细的和保密的信息。
分为五种类型：I：生产地点、设备、操作程序和人员II：原料药、原料药中间体、生产原料药和中间体使用的物料和药品III：包装材料IV：赋形剂、色素、调味剂、香料或生产这些物质所用的物料V：FDA接受的参考信息EDMF：European Drug Master File欧洲药物主文件档案。
是指欧洲制剂申请中有关原料药信息的文件，又称原料药主文件档案（ASMF）。
EDMF 只有在制剂申请的支持下才能提交。
EDMF分为两部分：1．申请人部分（AP）：供制剂申请人使用的非保密信息；2. 限制部分（RP）：EDMF持有人认为是保密的信息。
EDMF的使用范围：1. 新原料药2. 已知的但欧洲药典或其成员国药典没有收载的原料药3. 欧洲药典或成员国药典已收载的原料药ANDA：Abbreviated New Drug Application 美国简略新药申请。
是FDA规定的仿制药申请程序。
Generic：仿制的，非特殊的API：Active Pharmaceutical Ingredient 原料药Dossier：文档，档案。
TSE：Transmitting animal Spongiform Encephalopathy agent 传播性动物海绵状脑病体Q7A：ICH（国际协调会议）原料药GMP 指南。
阐述了原料药生产商应遵循的GMP 指导原则。
药品常用英语缩写
《GMP英语词汇及缩写》第一部分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 Ingrediet) 原料药又称：活性药物组分AirLock 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；Consignmecnt（Delivery）托销药品。
FDA（FOOD AND DRUG ADMINISTRA TION）：（美国）食品药品管理局IND（INVESTIGA TIONAL 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 APPLICA TION）：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BA TCH PRODUCTION：批量生产；分批生产BA TCH 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（OVER—THE—COUNTER DRUG）：非处方药第二部分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 ApplicationANOV A 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 AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence 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 PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products Committee第三部分常用缩略语A．A．A 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 Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd 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 Insepctor 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 Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GA TT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 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 Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HV AC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction 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 Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典。
医院处方里常用的英语缩写
医院处方里常用的英语缩写aa 各a.c. 饭前ad 至.ext. 外用a.m. 上午A.s.t.！皮试aq.dest. 蒸馏水alt.2h. 每隔2小时一次b.I.d. 每日二次Cito! 急速地!D.S. 给予标记g. 克h.s. 睡时I.d 皮内注射I.h 皮下注射I.m 肌肉注射I.v 静脉注射I.v.derp 静脉滴注I.v.drip 静脉滴注I.v.gtt 静脉滴注I.u 国际单位Lent! 慢慢地!m.d. 用法口授,遵照医嘱M.D.S. 混合,给予,标记M.f.pulv. 混合制成散剂mg. 毫克ml. 毫升m.s. 用法口授,遵照医嘱p.a.a. 用于患处p 单位p.c 饭后pg. 微克p.m 下午p.o. 口服pr.aur. 耳用prim.vic.No2 首剂倍量p.r.n 必要时pr.nar. 鼻用pr.nar. 鼻用pr.ocul. 眼用p.t.c. 皮试后q.6h. 每6小时q.2d. 每二天一次q.d. 每天一次q.h. 每小时q.I.d. 每日四次q.m. 每晨q.n. 每晚q.o.d. 隔日q.s. 适量q.w.d. 每周Rp. 取S. 标记,用法Sig. 标记,用法s.I.d. 每日一次s.o.s. 需要时St! 立即! Staim! 立即!stat.! 立即!T! 皮试t.I.d. 每天三次t.c.s. 皮试u. 单位常用药品名称缩写简表：英文缩写药品名称5Fu 5-氟脲嘧啶6MP 6-巯基嘌呤ACV 无环鸟苷ADR 阿霉素APC 复方阿斯匹林Aza 硫唑嘌呤BTX-A A型肉毒毒素CBZ 卡马西平Cef 头孢呋辛钠CEL 赛利洛尔CIP 环丙沙星CLX 头孢氨苄CO SMZ 复方磺胺甲基异恶唑CO VB 复方维生素B CPZ 头孢哌酮CsA 环孢素ACZP 氯硝西泮DMPPC 甲氧西林DOC 多西紫杉醇Dox 阿霉素DRL 屈洛昔芬EE 炔雌醇EM 红霉素EPO 促红细胞生长素FOM 磷霉素G-CSF 重组人粒细胞集落刺激因子GL 格列齐特Gli 格列吡嗪GM 庆大霉素GM1 单唾液酸四己糖神经节苷脂GNS 葡萄糖钠盐GS 葡萄糖GTW 雷公藤多苷HCL 盐酸黄酮哌酯Ils 白细胞介素IN 肌醇烟酸酯LD 左旋多巴LFX 洛非西定LM 盐酸左旋咪唑LMWH 低分子肝素LNG 左炔诺孕酮LTB4 白三烯B4LTG 拉莫三嗪LVFX 左氧氟沙星MEBO 美宝湿润烧伤膏MINO 米诺环素MMC 丝裂霉素MMF 霉酚酸酯MP 甲泼尼龙MZR 咪唑立宾NK-104 伊它伐他汀NM 硫酸新霉素NS 生理盐水NTL 奈替米星OFLX 氧氟沙星OTC 盐酸土霉素PASNa 对氨基水杨酸钠PB 苯巴比妥PPA 盐酸苯丙醇胺Pred 泼尼松PSS 藻酸双酯钠rhEGF 重组人表皮生长因子rhG-CSF 重组人粒细胞集落刺激因子RSG 罗格列酮Ru486 米非司酮SB 碳酸氢钠SBT 舒巴坦SD 磺胺嘧啶SDM 磺胺邻二甲氧嘧啶SFZSIZ 磺胺二甲异恶唑SG 磺胺脒SM2 磺胺二甲嘧啶SMD 磺胺对甲氧嘧啶SMM 磺胺间甲氧嘧啶SMZ 磺胺甲基异恶唑TAM 三苯氧胺TC 盐酸四环素TMP 甲氧苄氨嘧啶TNZ 替硝唑TOB 妥布霉素TPM 托吡酯VA 维生素AVAD 维生素AD VB1 维生素B1VB12 维生素B12 VB2 维生素B2VB6 维生素B6 VC 维生素CVD 维生素D VE 维生素EVPA 丙戊酸钠 VPA 丙戊酸钠ivgtt。
制药行业常用英语
不应当当作污染，除非含量超标，或者测得致病生物。
Calibration: 校验 证明某个仪器或装置在一适当的量程范围内所测得的结果与一参照物，或可追溯的标准相比在规定限度内。Computer System : 计算机系统
EP诉（Export application）：出口药申请（申请出口不被批准在美国销售的药品）
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）
Drug substance：原料药 Established name：确定的名称
Generic name：非专利名称 Proprietary name：专有名称；
INN（international nonproprietary name）：国际非专有名称
Narrative summary记叙体概要 Adverse effect：副作用 Adverse reaction：不良反应
Dietary supplement：食用补充品 COS/CEP 欧洲药典符合性认证
ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
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《GMP英语词汇及缩写》第一部分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 Ingrediet) 原料药又称：活性药物组分AirLock 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；Consignmecnt（Delivery）托销药品。
FDA（FOOD AND DRUG ADMINISTRA TION）：（美国）食品药品管理局IND（INVESTIGA TIONAL 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 APPLICA TION）：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BA TCH PRODUCTION：批量生产；分批生产BA TCH 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（OVER—THE—COUNTER DRUG）：非处方药第二部分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 ApplicationANOV A 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 AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence 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 PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products Committee第三部分常用缩略语A．A．A 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 Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd 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 Insepctor 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 Adminestration 管制药品管理。