制药行业英语
医药行业专业英语词汇词典
FDA和EDQM术语:CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFITS：受益RISKS：受害DRUG PRODUCT：药物产品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；INNINTERNATIONAL NONPROPRIETARY NAME：国际非专有名称ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典主要指USP、 NF．USPTHE UNITED STATES PHARMACOPEIA：美国药典NFNATIONAL FORMULARY：美国国家处方集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门指FDAIDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量每一剂量单位所含有效成分的量LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准NDA提供REGULATORY METHODOLOGY：质量管理方法REGULATORY METHODS VALIDATION：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类..质量技术要求文件以Q开头;再以a;b;c;d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:原料药的优良制造规范指南药物活性成分的GMP.GMP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/SPIC的权威翻译：药品生产检查相互承认公约APIActive Pharmaceutical Ingredient 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；ConsignmentDelivery托销药品..FDAFOOD AND DRUG ADMINISTRATION：美国食品药品管理局INDINVESTIGATIONAL 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NDANEW DRUG APPLICATION：新药申请ANDAABBREVIATED NEW DRUG APPLICATION：简化新药申请TREATMENT IND：研究中的新药用于治疗ABBREVIATEDNEWDRUG：简化申请的新药DMFDRUG 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CFRCODE 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 DRUGOVER—THE—COUNTER DRUG：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry 英国制药工业协会ADR Adverse Drug Reaction 药品不良反应AE Adverse Event 不良事件;不良反应AIM Active Ingredient Manufacturer 原料药制造商ANDA Abbreviated New Drug Application 简化新药申请ANOVA Analysis of Variance 方差分析ASM: Active Substance Manufacturer原料药制造商ATC 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 CDECentre for Pharmaceutical Administration CPA CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal Products CRA 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 FERfree sale certificates FSCsGCP 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 HSAHSA’s Medicines Advisory Committee MACIB Investigators BrochureICH International Conference for Harmonisation IDMC 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 JapanMR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs Mutual Recognition Agreements 互相认证同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities NCEsnew drug applications NDAsNSAID Non Steroidal Anti Inflammatory Drug NTA 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 characteristicsSPCTherapeutic Goods Administration TGAUSP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．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 美国药典专业英语词汇词素词根1. haplo;mono;uni ：单;一;独haploid 单倍体monoxide一氧化碳monoatomic单原子的2. bi;di;dipl;twi;du :：二;双;两;偶 biocolor 双色;dichromatic 双色的;diplobacillus 双杆菌 dikaryon 双核体twin ：孪生 dual 双重的3. tri :三;丙 triangle三角 triacylglycerol三酰甘油 tricarboxylic acid cycle 三羧酸循环4. quadri;quadru;quart;tetr;tetra：四 quadrilateral四边的 quadrivalent 四价的 quadruped四足动物tetrode四极管 tetracycline四环素5. pent;penta;quique五pentose戊糖pentagon五角形pentane戊烷quintuple 五倍的 pentose戊糖 pentomer五邻粒6. hex;hexa;sex 六 hexose已糖 hexapod六足动物hexapoda昆虫纲 hexamer 六聚体7. hepta;sept 七 heptane 庚烷 heptose 庚糖 heptoglobin七珠蛋白8. oct八 octpus 章鱼 octagon八角形 octane 辛烷 octase 辛糖9. enne;nona九 nonapeptide 九肽 enneahedron 九面体10. deca;deka 十 :decapod 十足目动物 decahedron 十面体 decagram 十克11. hecto; 百 hectometer百米 hectoliter百升 hectowatt 百瓦12. kilo;千 kilodalton KD 千道尔顿 kilobase 千碱基 kiloelectron volt 千电子伏特13. deci;十分之一;分 decimeter 分米decigram 十分之一克14. centi;百分之一15. milli;千分之一;毫millimole 毫摩尔milliliter 毫升16. micro;百万分之一;微;微小;微量microgram微克 microogranism微生物microecology微生态学micropipet微量移液器17. nano十亿分之一;毫微;纳nanosecond十亿分之一秒nanometer纳米18. demi;hemi;semi半 demibariel 半桶 hemicerebrum 大脑半球semiopaque 半透明 semi-allel半等位基因 semi-conductor半导体19. holo 全;整体;完全 holoenzyme 全酶holoprotein全蛋白 holocrine全质分泌20. mega巨大;兆;百万 megaspore大孢子;megabasse兆碱基megakaryocyte巨核细胞megavolt兆伏 megalopolitan特大城市21. macro 大;巨大;多macrophage巨噬细胞macrogamete大配子macroelement 常量元素 macromolecular大分子22. poly;multi;mult 多;复合polyacrylate聚丙烯酸酯 polymerase 聚合酶multichain多链的multinucleate 多核的 multicistronic mRNA多顺反子mRNA multicopy多拷贝1 chrom颜色chromophore生色团 chromosome染色体 chromatography色谱法2 melan;melano;nigr 黑melanoma黑素瘤melanin黑色素melanophore黑色素细胞3 xantho;flavo;fla;flavi;lute黄xanthophyl叶黄素 xanthous黄色的;黄色人种xathine黄嘌呤 flavin黄素flavone黄酮 letein黄体素;叶黄素flavin adenine dinucleotideFAD黄素腺嘌呤二核苷酸4 erythro; rub; rubrm; ruf;红erythrocyte红细胞erythromycin红霉素erythropoitinEPO促红细胞生成素5 chloro;chlor绿;氯chlorophyll叶绿素 chloride氯化物chloramphenicol氯霉素6 cyan;cyano 蓝;青紫色;氰cyanophyceae 蓝藻纲 cyanobacteria蓝细菌cyanide氰化物7 aur;glid;chrys金色aureomycin金霉素chrysose 金藻淀粉 chrysanthemum菊花 glidstone 金沙石glid 镀金8 leu;leuco;leuk;leuko;blan;alb无色;白色leucine亮氨酸leukaemia=leucosis白血病bleaching powder漂白粉albomycin白霉素四表示方位和程度的词素1 endo;ento;内;在内endocrine内分泌endocytosis胞吞作用 endogamy近亲繁殖 endolysin内溶素entoderm内胚层2 ec; ect; exc; extra 外;外面;表面ectoblast外胚层 ectoparasite 外寄生生物 extract 抽取;浸出3 meso 中;中间mesosphere 中圈;中层 mesoplast 中胚层质4 intra;intro;inter 在内;向内intra-allelic interaction 等位基因内相互作用 intracellular细胞内的interurban城市之间5 centri;centro;medi;mid 中心;中央;中间centrifuge离心 centriole 中心粒centrosome 中心体 centrogeng着丝基因6 epi;peri 上;外;旁epidermal growth factorEGF: 表皮生长因子 epibranchial上鳃的perilune 近月点7 sub;suc;suf;sug 下;低;小suborder 亚目 submucosa粘膜下层subclone亚克隆 subcellular亚细胞subsection小节;分部8 super;supra 上;高;超superconductor超导体superfluid 超流体superoxide 超氧化物supramolecular超分子的9 hyper 超过;过多hypersensitive 过敏的hyperelastic 超弹性的hypertension 高血压hyperploid 超倍体10 hypo下;低;次hypoglycaemia 低血糖 hypotension低血压hypophysis脑下垂体11 iso 等;相同;同iso-osmotic等渗的isopod等足目动物 isotope同位素12 oligo;olig少;低;寡;狭oligohaline 狭盐性 oligogene寡基因 oligomer寡聚体 oligophagous寡食性oligarchy寡头13 eury 多;宽;广eurythermal 广温的 euryhaline广盐性eurytopic species广幅种14 ultr 超ultra-acoustics 超声学ultra-structure超微结构ultroviolet紫外线15 infra 下;低;远infralittoral 潮下带;远岸的infrahuman类人生物infrared红外线的infrastructure基础结构;基本结构五表示动物不同器官和组织的词素1 cephal;capit;cran 头;头颅2 cyte 细胞3 carn;my;mya;myo;肉;肌肉4 haem;haemat;hem;aem;sangul 血5 soma;corp 体;身体6 some;plast 体;颗粒7 hepa;hepat 肝 heparin 肝素 hepatopancreas肝胰腺 hepatocyte 肝细胞hepatoma肝癌8 ren;nephr 肾adrnal肾上腺的 nephridia肾管 nephron肾单位9 card;cord 心 cardiotoxin 心脏毒素 cardiovascular center 心血管中枢electrocardiogram心电图 concord一致;和谐10 ophthalm;ocell;ocul 眼ophthalmology眼科学ophthalmia眼炎ophthalmologist眼科专家11 branchi 鳃 filibranch丝鳃 lamellibrnch瓣鳃 sencondary branchium次生鳃12 brac ;brachi 腕;手臂 brachiolaria 短腕幼虫brachionectin臂粘连蛋白bracelet手镯13 dent;odont 牙齿 dentin牙质 odontphora 齿舌 odontoblast成牙质细胞14 plum羽 plumatus 羽状的 plumule绒毛 plumage 鸟的羽毛15 foli;foil 叶 follicle滤泡 foiling叶形 foliage 叶子 foliose 多叶的药名常用词首ace- 乙酰基acet- 醋；醋酸；乙酸acetamido- 乙酰胺基acetenyl- 乙炔基acetoxy- 醋酸基；乙酰氧基acetyl- 乙酰基aetio- 初allo- 别allyl- 烯丙基；CH2=CH-CH2-amido- 酰胺基amino- 氨基amyl- ①淀粉②戊基amylo- 淀粉andr- 雄andro- 雄anilino- 苯胺基anisoyl- 茴香酰；甲氧苯酰anti- 抗apo- 阿朴；去水aryl- 芳香基aspartyl- 门冬氨酰auri- 金基；三价金基aza- 氮杂azido- 叠氮azo- 偶氮basi- 碱baso- 碱benxoyl- 苯酰；苯甲酰benzyl- 苄基；苯甲酰bi- 二；双；重biphenyl- 联苯基biphenylyl- 联苯基bis- 双；二bor- 硼boro- 硼bromo- 溴butenyl- 丁烯基有1、2、3位三种butoxyl- 丁氧基butyl- 丁基butyryl- 丁酰caprinoyl- 癸酰caproyl- 己酰calc- 钙calci- 钙calco- 钙capryl- 癸酰capryloyl- 辛酰caprylyl- 辛酰cef- 头孢头孢菌素族抗生素词首chlor- ①氯②绿chloro- ①氯②绿ciclo- 环cis- 顺clo- 氯crypto- 隐cycl- 环cyclo- 环de- 去；脱dec- 十；癸deca- 十；癸dehydro- 去氢；去水demethoxy- 去甲氧基demethyl- 去甲基deoxy- 去氧des- 去；脱desmethyl- 去甲基desoxy- 去氧dex- 右旋dextro- 右旋di- 二diamino- 二氨基diazo- 重氮dihydro- 二氢；双氢endo- 桥epi- 表；差向epoxy- 环氧erythro- 红；赤estr- 雌ethinyl- 乙炔基ethoxyl- 乙氧基ethyl- 乙基etio- 初eu- 优fluor- ①氟②荧光fluoro- ①氟②荧光formyl- 甲酰基guanyl- 脒基hepta- 七；庚hetero- 杂hexa- 六；己homo- 高比原化合物多一个-CH2-hypo- 次io- 碘indo- 碘iso- 异keto- 酮laevo- 左旋leuco- 白levo- 左旋mercapto- 巯基meso- ①不旋；内消旋②中间③中位蒽环的9、10位meta- ①间有机系统用名②偏无机酸用methoxy- 甲氧基methyl- 甲基mono- 一；单neo- 新nitro- 硝基nitroso- 亚硝基nona- 九；壬nor- 去甲；降；正nov- 新novo- 新oct- 八；辛octa- 八；辛octo- 八；辛ortho- ①邻位②正③原oxalo- 草oxo- 氧代oxy- ①氧②羟基误称;但常用para- ①对位②副俗名penta- 五；戊per- ①高②过phen- 苯pheno- 苯phenoxy- 苯氧基phenyl- 苯基phospho- 磷；磷酸phosphor- 磷；磷酸phosphoro- 磷；磷酸phyllo- 叶poly- 多；聚propyl- 丙基proto- 原pseudo- 假；伪；拟ribosyl- 核糖基sec- ①另指CH3CH2CHCH3-型烃基②semi- 半silico- 硅strept- 链strepto- 链sulf- 硫sulfa- 磺胺磺胺类药物词头sulfo- ①硫代②磺基sulph- 硫代sulpho- ①硫代②磺基tert- ①特指CH3…CCH32-型烃基②叔tetra- 四thio- 硫trans- 反式；转tri- 三undeca- 十一valyl- 缬氨酰基vinyl- 乙烯基xantho- 黄色药名常用词尾-al 醛-aldehyde 醛-amide 酰胺-amidine 脒-amine 胺-ane 烷-ase 酶-ate ①盐②酯-azide 叠氮；-N3-caine 卡因局部麻醉药词尾-carbonyl 羰基-carboxamide 甲酰胺-carboxylic acid 羧酸-cidin 杀……菌素-cillin 青霉素；西林青霉素族抗生素词尾-cycline 四环素四环素族抗生素词尾-diol ①二醇②二酚-dione 二酮-disulfide 二硫化物-ene 烯-enol 烯醇-ester 酯-flavine 黄素-form 仿俗名词尾-genin 甙元旧称配基-hydrin 醇-ine 碱；素生物碱词尾-lactone 内酯-lysin 溶素俗名词尾-micin 霉素抗生素词尾-mycetin 霉素；菌素抗生素词尾-mycin 霉素抗生素词尾-nitrile 腈-ol ①醇②酚-olol 心安心安类药物词尾-one 酮-ose 糖-oside 糖甙-oxide 氧；氧化物-oyl 酰-quine 奎俗名尾词-sporin 孢菌素抗生素词尾-sullide 硫化物-sulfone 砜-sulfoxide 亚砜-thioic acid 硫代酸-thione 硫酮-thione 硫酮-toxin 毒-triol 三醇-tropin 托品俗名尾词-urea 脲-xanthin 黄质-yl 基一价基-yne 炔常用分析化学词汇C to E玻璃漏斗 Glass funnel long stem试管 test tube test tube brush test tube holder test tube rack 蒸发皿 evaporating dish small烧杯 beaker锥形瓶 Erlenmeyer量筒 grad cylinder洗瓶 plastic wash bottle勺皿 casserole ;smallstoppered flask分液漏斗 separalory funnelwater bath/oil bathstrring barmagnetic stirrer冷凝器 condenserBallast bottle圆颈烧瓶 Round-buttom flask试剂瓶 reagent bottles托盘天平 platform balance 台秤0.1g 托盘pan 指针刻度表pointer and scale crossbeams and sliding weights 游码分析天平 two-pan/single-pan analytical balance 滴定管 burette glass beadbasic nozzle移液管 pipette 胖肚 elongated glass bulb洗耳球 rubber suction bulb玻棒 glass rod玻璃活塞 stopcock容量瓶 pyknowmeter flasks比重瓶 one-markvolumetric flasks胖肚吸管 one-mark pipette刻度吸管 graduated pipettes实验仪器清单1、柜子中四、抽屉中：锥形瓶conical flask 250ml×4 药匙medicine spoon×1Erlenmeyer flask 100 ml×3 滴管drip tube;dropper×2烧杯beaker 500 ml×1 玻棒Glass stic×2250 ml×3 木试管夹test tube clamp;test tube holder×1100 ml×3 胖肚吸管straws 25 ml×150 ml×2 10 ml×1容量瓶volumetric flask 100 ml×2 乳钵morta×150 ml×4 洗耳球ear wadhing bulb碘量瓶 iodin numoe flask;iodineflask 500 ml×3试剂瓶 reagent bottle 无色×2棕色×2 配洗液：量筒cylinder 100 ml×1 K2Cr2O72g+5ml水→65mlH2SO4graduated cylinder10ml×1 边加边搅拌stir..二、台面上仪器：一般仪器的洗涤wash铁支架siderocradle+蝴蝶架白瓷板White Porcelain Board 一清点仪器to count;to make an inventory酸式滴定管Acid burette 25 ml×1 配洗液 Lotion碱式滴定管Alkali burette25 ml×1 一般仪器的洗涤三、公用柜中：二滴定管buret;burette直型冷凝器rectocondensor×1 容量瓶volumetric flask漏斗架 funnel stand ×2 移液管pipe水浴锅water bath kettle ×1温度计Thermometer;hygrometer;hydroscope ×1电炉electric furnace;electric hot plate;electric stove 四人一个分析化学：analytical chemistry定性分析：qualitative analysis定量分析：quantitative analysis物理分析：physical analysis物理化学分析：physico-chemical analysis仪器分析法：instrumental analysis流动注射分析法：flow injection analysis；FIA顺序注射分析法：sequentical injection analysis;SIA化学计量学：chemometrics绝对误差：absolute error相对误差：relative error系统误差：systematic error可定误差：determinate error随机误差：accidental error不可定误差：indeterminate error准确度：accuracy精确度：precision偏差：debiation;d平均偏差：average debiation相对平均偏差：relative average debiation标准偏差标准差：standerd deviation;S相对平均偏差：relatibe standard deviation;RSD变异系数：coefficient of variation误差传递：propagation of error有效数字：significant figure置信水平：confidence level显着性水平：level of significance合并标准偏差组合标准差：pooled standard debiation 舍弃商：rejection quotient ;Q滴定分析法：titrametric analysis滴定：titration容量分析法:volumetric analysis化学计量点：stoichiometric point等当点：equivalent point电荷平衡：charge balance电荷平衡式：charge balance equation质量平衡：mass balance物料平衡：material balance质量平衡式：mass balance equation酸碱滴定法：acid-base titrations质子自递反应：autoprotolysis reaction质子自递常数：autoprotolysis constant质子条件式:proton balance equation酸碱指示剂：acid-base indicator指示剂常数：indicator constant变色范围：colour change interval混合指示剂：mixed indicator双指示剂滴定法：double indicator titration 非水滴定法：nonaqueous titrations质子溶剂：protonic solvent酸性溶剂：acid solvent碱性溶剂：basic solvent两性溶剂:amphototeric solvent无质子溶剂：aprotic solvent均化效应：differentiating effect区分性溶剂：differentiating solvent离子化：ionization离解：dissociation结晶紫：crystal violet萘酚苯甲醇: α-naphthalphenol benzyl alcohol奎哪啶红：quinadinered百里酚蓝：thymol blue偶氮紫：azo violet溴酚蓝：bromophenol blue配位滴定法：compleximetry乙二胺四乙酸：ethylenediamine tetraacetic acid;EDTA 螯合物：chelate compound金属指示剂：metal lochrome indcator氧化还原滴定法：oxidation-reduction titration碘量法：iodimetry溴量法：bromimetry溴量法：bromine method铈量法：cerimetry高锰酸钾法：potassium permanganate method条件电位：conditional potential溴酸钾法：potassium bromate method硫酸铈法：cerium sulphate method偏高碘酸：metaperiodic acid高碘酸盐：periodate亚硝酸钠法：sodium nitrite method重氮化反应：diazotization reaction重氮化滴定法：diazotization titration亚硝基化反应：nitrozation reaction亚硝基化滴定法：nitrozation titration外指示剂：external indicator外指示剂：outside indicator重铬酸钾法：potassium dichromate method沉淀滴定法：precipitation titration容量滴定法：volumetric precipitation method 银量法：argentometric method重量分析法：gravimetric analysis挥发法：volatilization method引湿水湿存水：water of hydroscopicity包埋藏水：occluded water吸入水：water of imbibition结晶水：water of crystallization组成水：water of composition液-液萃取法：liquid-liquid extration溶剂萃取法：solvent extration反萃取：counter extraction分配系数：partition coefficient分配比：distribution ratio离子对离子缔合物：ion pair沉淀形式：precipitation forms称量形式：weighing forms物理分析：physical analysis物理化学分析：physicochemical analysis 仪器分析：instrumental analysis电化学分析：electrochemical analysis 电解法：electrolytic analysis method 电重量法：electtogravimetry库仑法：coulometry库仑滴定法：coulometric titration电导法：conductometry电导分析法：conductometric analysis电导滴定法：conductometric titration 电位法：potentiometry直接电位法：dirext potentiometry电位滴定法：potentiometric titration 伏安法：voltammetry极谱法：polarography溶出法：stripping method电流滴定法：amperometric titration化学双电层：chemical double layer相界电位：phase boundary potential金属电极电位：electrode potential化学电池：chemical cell液接界面：liquid junction boundary原电池：galvanic cell电解池：electrolytic cell负极：cathrode正极：anode电池电动势：eletromotive force指示电极：indicator electrode参比电极：reference electroade标准氢电极：standard hydrogen electrode一级参比电极：primary reference electrode饱和甘汞电极：standard calomel electrode银－氯化银电极：silver silver-chloride electrode 液接界面：liquid junction boundary不对称电位：asymmetry potential表观PH值：apparent PH复合PH电极：combination PH electrode离子选择电极：ion selective electrode敏感器：sensor晶体电极:crystalline electrodes均相膜电极：homogeneous membrance electrodes非均相膜电极：heterog eneous membrance electrodes非晶体电极：non- crystalline electrodes刚性基质电极：rigid matrix electrode流流体载动电极：electrode with a mobile carrier气敏电极：gas sensing electrodes酶电极：enzyme electrodes金属氧化物半导体场效应晶体管：MOSFET离子选择场效应管：ISFET总离子强度调节缓冲剂：total ion strength adjustment buffer;TISAB永停滴定法：dead-stop titration双电流滴定法双安培滴定法：double amperometric titration普朗克常数：Plank constant电磁波谱：electromagnetic spectrum光谱：spectrum光谱分析法：spectroscopic analysis原子发射光谱法：atomic emission spectroscopy质量谱：mass spectrum质谱法：mass spectroscopy;MS紫外－可见分光光度法：ultraviolet and visible spectrophotometry;UV-vis 肩峰：shoulder peak末端吸收：end absorbtion生色团：chromophore助色团：auxochrome红移：red shift长移：bathochromic shift短移：hypsochromic shift蓝紫移：blue shift增色效应浓色效应：hyperchromic effect减色效应淡色效应：hypochromic effect强带：strong band弱带：weak band吸收带：absorption band透光率：transmitance;T吸光度：absorbance谱带宽度：band width杂散光：stray light噪声：noise暗噪声：dark noise散粒噪声：signal shot noise闪耀光栅：blazed grating全息光栅：holographic graaing光二极管阵列检测器：photodiode array detector 偏最小二乘法：partial least squares method ;PLS褶合光谱法：convolution spectrometry褶合变换：convolution transform;CT离散小波变换：wavelet transform;WT多尺度细化分析：multiscale analysis供电子取代基：electron donating group吸电子取代基：electron with-drawing group 荧光：fluorescence荧光分析法：fluorometryX-射线荧光分析法：X-ray fulorometry原子荧光分析法：atomic fluorometry分子荧光分析法：molecular fluorometry振动弛豫：vibrational relexation内转换：internal conversion外转换：external conversion体系间跨越：intersystem crossing激发光谱：excitation spectrum荧光光谱：fluorescence spectrum斯托克斯位移：Stokes shift荧光寿命：fluorescence life time荧光效率：fluorescence efficiency荧光量子产率：fluorescence quantum yield 荧光熄灭法：fluorescence quemching method散射光：scattering light瑞利光：Reyleith scanttering light拉曼光：Raman scattering light红外线：infrared ray;IR中红外吸收光谱：mid-infrared absorption spectrum;Mid-IR 远红外光谱：Far-IR微波谱：microwave spectrum;MV红外吸收光谱法：infrared spectroscopy红外分光光度法：infrared spectrophotometry振动形式：mode of vibration伸缩振动：stretching vibration对称伸缩振动：symmetrical stretching vibration不对称伸缩振动：asymmetrical stretching vibration弯曲振动：bending vibration变形振动：formation vibration面内弯曲振动:in-plane bending vibration;β剪式振动：scissoring vibration;δ面内摇摆振动：rocking vibration;ρ核磁共振：nuclear magnetic resonance;NMR核磁共振波谱：NMR spectrum核磁共振波谱法：NMR spectroscopy扫场：swept field扫频：seept frequency连续波核磁共振：continuous wave NMR;CW NMRFourier变换NMR：PFT-NMR;FT-NMR二维核磁共振谱：2D-NMR质子核磁共振谱：proton magnetic resonance spectrum;PMR 氢谱：1H-NMR碳－13核磁共振谱：13C-NMR spectrum;13CNMR自旋角动量：spin angular momentum磁旋比：magnetogyric ratio磁量子数：magnetic quantum number;m进动：precession弛豫历程：relaxation mechanism局部抗磁屏蔽：local diamagnetic shielding屏蔽常数：shielding constant化学位移：chemical shift国际纯粹与应用化学协会：IUPAC磁各向异性：magnetic anisotropy远程屏蔽效应：long range shielding effect结面：nodal plane自旋－自旋偶合：spin-spin coupling自旋－自旋分裂：spin=spin splitting单峰：singlet;s双峰：doublet;d三重峰：triplet;t四重峰：quartet五重峰：quintet六重峰：sextet偕偶：geminal coupling邻偶：vicinal coupling远程偶合：long range coupling磁等价：magnetic eqivalence自旋系统：spin system一级光谱：first order spectrum二级光谱二级图谱：second order spectrumC-H光谱：C-H correlated spectroscopy;C-H COSY质谱分析法：mass spectrometry质谱：mass spectrum;MS棒图：bar graph选择离子检测：selected ion monitoring ;SIM直接进样：direct probe inlet ;DPI接口：interface气相色谱－质谱联用：gas chromatography-mass spectrometry;GC-MS高效液相色谱－质谱联用：high performance liquid chromatography-mass spectrometry;HPLC-MS电子轰击离子源：electron impact source;EI离子峰：quasi-molecular ions化学离子源：chemical ionization source;CI场电离：field ionization;FI场解析：field desorptiion;FD快速原子轰击离子源：fast stom bombardment ;FAB质量分析器：mass analyzer磁质谱仪：magnetic-sector mass spectrometer四极杆质谱仪四极质谱仪：quadrupole mass spectrometer 原子质量单位:amu离子丰度：ion abundance相对丰度相对强度：relative avundance基峰：base peak质量范围：mass range分辨率：resolution灵敏度：sensitivity信噪比：S/N分子离子：molecular ion碎片离子：fragment ion同位素离子：isotopic ion亚稳离子：metastable ion亚稳峰：metastable peak母离子：paren ion子离子：daughter含奇数个电子的离子：odd electron含偶数个电子的离子：even eletron;EE均裂：homolytic cleavage异裂非均裂：heterolytic cleavage半均裂：hemi-homolysis cleavage重排：rearragement分子量：MWα－裂解：α-cleavage固定相：stationary phase化学键合相：chemically bonde phase封尾、封顶、遮盖：end capping手性固定相：chiral stationary phase;CSP恒组成溶剂洗脱：isocraic elution梯度洗脱：gradient elution紫外检测器：ultraviolet detector;UVD荧光检测器：fluorophotomeric detector;FD电化学检测器：ECD示差折光检测器：RID光电二极管检测器：photodiode array detector ;DAD 三维光谱－波谱图：3D-spectrochromatogram蒸发光散射检测器：evaporative light scattering detector;ELSD 释药系统drug delivery system;DDS中国药典Chinese Pharmacopoeia;ChP美国药典The United States Pharmacopoeia;USP美国国家处方集The National Formulary;NF英国药典British Pharmacopoeia;BP欧洲药典European Pharmacopoeia;Ph.Eup国际药典The International Pharmacopoeia;Ph.Int良好药品实验研究规范Good Laboratory Practice;GLP良好药品生产规范Good Manufacture Practice;GMP良好药品供应规范Good Supply Practice;GSP良好药品临床试验规范Good Clinical Practice;GCP分析质量管理Analytical Quality Control;AQC边缘效应 edge effect斑点定位法 localization of spot放射自显影法 autoradiography原位定量 in situ quantitation生物自显影法 bioautography归一法 normalization method内标法 internal standard method外标法 external standard method叠加法 addition method普适校准曲线、函数 calibration function or curve function谱带扩展加宽 band broadening分离作用的校准函数或校准曲线 universal calibration function or curve of separation加宽校正 broadening correction加宽校正因子 broadening correction factor溶剂强度参数ε0;solvent strength parameter洗脱序列 eluotropic series洗脱淋洗 elution等度洗脱 gradient elution梯度洗脱 gradient elution再循环洗脱 recycling elution线性溶剂强度洗脱 linear solvent strength gradient程序溶剂 programmed solvent程序压力 programmed pressure程序流速 programmed flow展开 development上行展开 ascending development下行展开 descending development双向展开 two dimensional development环形展开 circular development离心展开 centrifugal development向心展开 centripetal development径向展开 radial development多次展开 multiple development分步展开 stepwise development连续展开 continuous development梯度展开 gradient development匀浆填充 slurry packing停流进样 stop-flow injection阀进样 valve injection柱上富集 on-column enrichment流出液 eluate柱上检测 on-column detection柱寿命 column life柱流失 column bleeding显谱 visualization活化 activation反冲 back flushing脱气 degassing沟流 channeling过载 overloading分析化学方面的词汇abatement 1:减少 2：消除；ablution 1:清洗 2：洗净液；。
药学专业英语PPTPPT课件
taking notes on important points and technical terms to aid in comprehension and review.
Classification and characteristics of pharmaceutical English literature
Writing
Writing skills for pharmaceutical English papers
Use appropriate language
Pharmaceutical English is a formal language, so it is important to use appropriate vocabulary and sentence structure. Avoid colloquial language or jargon that may be misinterpreted.
committing to a regular schedule of reading to improve your comprehension and familiarity with pharmaceutical English.
Active review
actively reviewing and summarizing the content you have read to ensure comprehension and retention.
Organize information logically
The structure of the paper should be clear and logical, with a well-defined introduction, methods, results, and conclusion. Each section should flow naturally and build upon the previous one.
医药行业专业英语词汇(词典)
FDA 和 EDQM 术语 :CLINICAL TRIAL ：临床试验ANIMAL TRIAL ：动物试验ACCELERATED APPROV AL ：加速批准STANDARD DRUG ：标准药物INVESTIGATOR ：研究人员；调研人员PREPARING AND SUBMITTING ：起草和申报SUBMISSION ：申报；递交BENIFIT （ S）：受益？RISK （ S）：受害？DRUG PRODUCT ：药物产品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ADVERSE EFFECT ：副作用ADVERSE REACTION ：不良反应PROTOCOL ：方案ARCHIV AL COPY ：存档用副本REVIEW COPY ：审查用副本OFFICIAL COMPENDIUM ：法定药典（主要指USP、 NF）．USP（ THE UNITED STATES PHARMACOPEIA ）：美国药典NF （NATIONAL FORMULARY ）：（美国）国家处方集OFFICIAL ＝ PHARMACOPEIAL= COMPENDIAL ：药典的；法定的；官方的AGENCY ：审理部门（指FDA ）IDENTITY ：真伪；鉴别；特性STRENGTH ：规格；规格含量（每一剂量单位所含有效成分的量）LABELED AMOUNT ：标示量REGULATORY SPECIFICATION ：质量管理规格标准（ NDA 提供）REGULATORY METHODOLOGY ：质量管理方法REGULATORY METHODS V ALIDATION ：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICH （ International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) 人用药物注册技术要求国际协调会议ICH 文件分为质量、安全性、有效性和综合学科 4 类。
制药行业GMP英文词汇
制药行业GMP英文词汇Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。
制药行业英语翻译Translation-in-Pharmacy
现场演练
质量控制实验室一般应与生产区分开。这对生物检定、微生物检
Subject Predicate
Object
Attribute / Modifier
Adverbial
Complement
English is just ABC.
1.If you know Chinese Pronunciation, you know most of English. What you should do is putting them together like we learn to Chinese characters. 2.What is the pronunciation of these phonetic symbol? Vowel: [ɪ] [æ ] [əʊ] [e] [tʃ]
More Examples of Passive Voice
• Exa.2 6.6 The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations .(Chapter 6 Quality Control)
Me You
I They
Vowels + Consonants=Words
Pleasure Dress Head Hijack Pest Soup Performance Qualification Monitor Public medium Strength Dose Manufacture Container
医药行业专业英语词汇_非常有用
医药行业专业英语词汇_非常有用1. Medicine (药品): 指用于治疗、预防或诊断疾病的物质。
2. Pharmaceutical (制药): 涉及药品的研究、开发、生产和销售。
3. Clinical trial (临床试验): 在人体上进行的药物或治疗方法测试。
4. Therapeutic (治疗): 指药物或治疗方法的疗效。
5. Side effect (副作用): 药物或治疗方法产生的非预期效果。
6. Dosage (剂量): 药物的使用量。
7. Bioavailability (生物利用度): 药物在体内可被利用的程度。
8. Pharmacokinetics (药代动力学): 研究药物在体内的吸收、分布、代谢和排泄。
9. Pharmacodynamics (药效动力学): 研究药物如何影响生物体。
10. Biopharmaceutics (生物制药学): 研究生物体内药物的物理、化学和生物学性质。
11. Regulatory affairs (法规事务): 涉及药品的法规制定、遵守和监管。
12. Drug discovery (药物发现): 寻找新的药物分子或治疗方法。
13. Drug development (药物开发): 将新发现的药物分子转化为可用的药物。
14. Generic drug (仿制药): 与原研药具有相同活性成分的药物。
15. Biologics (生物制品): 由生物体产生的药物，如抗体、激素等。
16. Overthecounter (OTC) drug (非处方药): 不需要医生处方即可购买的药物。
17. Prescription drug (处方药): 需要医生处方才能购买的药物。
18. Drug interaction (药物相互作用): 两种或多种药物同时使用时产生的相互作用。
19. Adverse event (不良事件): 在药物使用过程中出现的非预期反应。
制药行业常用英语词汇中英文对照表
1 2 3 4 5 6 7 8 9 10 11
制药行业常用英语词汇中英文对照
英文原文 Application file Acceptance criteria Active moiety
Additives Adventitious agents Analytical procedures
Anti-microbial Antimicrobial preservatives
83
Glycosylation sites
84
Guidance
85
Guideline
86
Higher order structure
87
Holding times
88
Human or animal origin
89
Immunological activity
90
Immunochemical properties
Solvents
191
Sorption
192
Specifications
193
Specificity
缩小规模模型 放大批次
二级/三级/四级结构 次级包装 章节 子章节 灵敏度 有效期 跳检 溶解性 溶剂 吸附 质量标准 专属性
194
Stability
195
Starting materials
196
Proprietary name
157
Purification steps
158
Purity
159
Quality
160
Quality module
161
Quality overall summary (QOS)
医药行业专业英语词汇(词典)
FDA和EDQM术语:CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUG PRODUCT：药物产品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ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIV AL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF）．USP（THE UNITED STATES PHARMACOPEIA）：美国药典NF（NATIONAL FORMULARY）：（美国）国家处方集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）REGULATORY METHODOLOGY：质量管理方法REGULATORY METHODS V ALIDATION：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。
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
制药行业一些英语词汇总结
制药行业一些英语词汇总结FDA（Food and drug administration ）：（美国国家）食品药品管理局IND（Investigation 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）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U．S．Public Health Service：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所Clinical trial：临床试验Animal trial：动物试验Accelerated approval：加速批准Standard drug：标准药物Investigator：研究人员；调研人员Preparing and Submitting：起草和申报Submission：申报；递交Benefit（S）：受益Risk (S）：受害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Archival copy：存档用副本Review copy：审查用副本Official compendium：法定药典（主要指USP、NF）．USP（The united states Pharmacopeia）：美国药典（现已和NF合并一起出版）NF（National formulary）：（美国）国家药品集OFFICIAL＝Pharmacopeia = COMPENDIAL：药典的；法定的；官方的Agency：审理部门（指FDA等）Sponsor：主办者（指负责并着手临床研究者）Identity：真伪；鉴别；特性Strength：规格；规格含量（每一剂量单位所含有效成分的量）Labeled amount：标示量Regulatory specification：质量管理规格标准（NDA 提供）Regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）Regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）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 forHuman Use)人用药物注册技术要求国际协调会议Acceptance Criteria: 接收标准(接收测试结果的数字限度、范围或其它合适的量度标准) Active Pharmaceutical Ingredient (API) (or Drug Substance): 活性药用成分(原料药)旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。
制药行业英语词汇
Oral solid dosage form / Oral solid preparation 口服固体制剂Materials [mə'tɪərɪəlz]物料，材料Raw materials 原辅料Starting materials 起始物料Packing materials 包装材料Active pharmaceutical ingredient API [,fɑːmə'suːtɪk(ə)l; -'sjuː-]原料ingredient [ɪn'griːdɪənt] n. 原料；要素；组成部分adj. 构成组成部分的Excipient , adjuvant 辅料excipient [ik'sipint] n. 【药物】赋形剂adjuvant ['ædʒʊv(ə)nt] n. [药] 佐药；助理员adj. 辅助的Diluents 稀释剂Fillers 填充剂Starch 淀粉starch [stɑːtʃ]Dextrin 糊精dextrin ['dekstrɪn]Lactose 乳糖lactose ['læktəʊz; -s]Moistening agent , humectant [hjʊ'mekt(ə)nt]润湿剂Adhesive , binder 粘合剂[əd'hiːsɪv; -zɪv]Ethanol['eθənɒl]乙醇Disintegrants disintegrant [dɪs'ɪntɪɡrənt] 崩解剂Lubricant ['luːbrɪk(ə)nt]润滑剂Glidants 助流剂Antiadherent 抗粘剂Talc [tælk] 滑石粉Intermediates 中间体Finished product 最终成品Supper 供应商Distributor 分销商Manufacturer [,mænjʊ'fæktʃ(ə)rə(r)] 生产商Audit ['ɔːdɪt]审计Tablet 片剂Granules [grænju:ls]颗粒剂Capsules 胶囊剂Powder 散剂Pills 丸剂Compressed tablet 普通片Coated tablet 包衣片Sugar coated tablet 糖衣片Film coated tablet 薄膜衣片Enteric coated tablet 肠溶衣片Effervescent tablet [efə'vesənt]泡腾片Chewable tablet 咀嚼片Dispersible tablet 分散片Sustained release tablet 缓释片Controlled release tablet 控释片Multilayer tablet ['mʌltɪleɪə]多层片Manufacturing process 生产工艺Milling / grinding ['graɪndɪŋ]碾碎Sifting 过筛Dispensing 配料Blending ['blendɪŋ]混合Granulating / granulation [,ɡrænjʊ'leɪʃən]成粒，制粒Drying 干燥Tablet compression 压片compression [kəm'preʃ(ə)n] n. 压缩，浓缩；压榨，压迫Dedust [di:'dʌst]除尘Coating 包衣Polish ['pɒlɪʃ] 抛光Dies arrangement 配模arrangement [ə'reɪn(d)ʒm(ə)nt] n. 布置；整理；准备dies ['daii:z] n. [机] 模具（名词die的复数）；（拉）日n. (Dies)人名；(英)戴斯；(西)迭斯v. 死亡；消失（动词die的第三人称单数形式）；凋谢Packing 包装Bottle washing 洗瓶Bottle drying 烘瓶Packaging 包装，打包Labeling 贴签Filling 填充，灌装Capsule shell 胶囊壳shell [ʃel]n. 壳，贝壳；炮弹；外形vt. 剥皮；炮轰vi. 剥落；设定命令行解释器的位置Blister packing 起泡包装Inner packing material 内包材Outer packing material 外包材Whole test 全检Weight 重量Fineness 细度，粒度Particle size 粒度Loss on drying 干燥失重Content 含量Disintegration 崩解度Dissolution 溶出度Appearance 外观Quality 质量Quantity 数量Equipment / facility / apparatus / device 设备Process step 工艺步骤Weighing & dispensing 称配Granulation 制粒Compression 压片Coating 包衣Capsule filling 胶囊填充Batch production instruction / order 批生产指令Standard operation procedure 标准操作规程Formulation 处方Verification 确认，检定Calibration 校准Qualification 确认Validation 验证Authentication 认证Weighing cover 称重罩Weighting box 称重柜Balance 天平Electronic platform scale 电子台秤Vibrating sieve 振荡筛Mesh 网眼Grinder / pulverizer 粉碎机Inlet 进料口Steel tooth 钢齿Annular sieve plate 换装筛板Outlet 出粉口Charging hole 加料口Horizontal shaft 水平轴Shaking device 抖动装置Air bleeding pocket 放气袋Wet granulation 湿法制粒Dry granulation 干法制粒Spray granulation 喷雾制粒Mixing granulator 混合制粒机Pneumatic lid-opening device 启动开盖装置Cutting motor 切割电机Cooling water enters 冷却水进口Air admission orifice 进气管口Cooling water out 冷却水出口Touch screen 触摸屏Stirring motor 搅拌电机Power supply 电源Compressed air source 压缩空气源Controller 控制器Cutting knife 造粒刀Drum lid 桶盖Drum 盛料筒Discharge hole 出料口Stirrer 搅拌器Driving belt 传送皮带Machine base 机座Fluid bed granulator 流化床制粒机Hot air circulating oven 热风循环烘箱Heater 加热器Fan 风扇Filter gauze 滤网Mixing machine 混合机Quality test 质量检查Weight difference 片重差异Hardness 硬度Rigidity 脆碎度Rotary tablet press 旋转式压片机Die 冲模Punch 冲头Upper punch 上冲Upper pinch roller 上压轮Filling support 填充架Powder scraper 刮粉器Die 模圈Lower punch 下冲Tablet weight adjuster 片中调节器Lower pinch roller 下压轮ourlet adjuster 出片调节器coating 包衣isolated layer 隔离层sub-coating layer 粉衣层sugar-coating layer 糖衣层colored sugar-coating layer 有色糖衣层polishing 打光coating machine / coater 包衣机sidedoor 侧门upper box 上箱体lower box 下箱体airtight chamber 密闭工作室coating platen 包衣滚筒big sprocket 大链轮tensioner 涨紧轮cycle chain 链条washing pan 清洗盘small sprocket 小链轮electromotor 电动机capsule filling machine 胶囊填充机adjusting screw 填充杆调节螺钉upper die-set 上模架column 立柱powder loop 盛粉环metering plate 计量盘lock screw 锁紧螺钉fixed screw 固定螺钉gland flange 压板scale 标尺cover 盖板filling bar 填充杆powder scraper 刮粉器hopper 胶囊料斗liner bearing 直线轴承fork slider 拨叉滑块sliding valve 滑动门阀knob 旋钮baffle 挡板fastening screw 紧固螺钉order fork 顺序叉shifting fork 胶囊拨叉inverted trough 胶囊导槽lyophilized products / freeze drying preparation 冻干产品personnel 人员equipment 设备materials 物料regulations 法规environment 环境cross-contamination 交叉污染positive pressure 正压negative pressure 负压weighing room 称量室downflow booth 垂直层流工作室fan drive system 风机驱动系统HEPA filterHigh efficiency particulate air filter 高效过滤器Bleed air 排风Containment zone 控制区Background environment 背景环境Clean area 洁净区Grade A BUnclean area 一般区Differential pressure 压差Air speed 风速Temperature 温度Humidity 湿度Electronic balance 电子天平Operation keys 操作键Display with backlight 背光显示屏Model plate 型号标牌Draft shield element 放风圈Weighing pan 秤盘Draft shield 防风罩Leveling feet 水平调节脚Hager 秤钩AC adapter socket 交流电源适配器插座Interface 接口Solution preparation 配液Thick preparation 浓配Thin preparation 稀配Tanks for solution preparation 配液灌Sight glass 视镜Hatch 人孔Liquid level meter 液位计Liquid outlet 出液口Condensate water 冷凝水Steam inlet 蒸汽入口Automatic control 自动化控制Sterile filtration 无菌过滤Clean in place 在线清洗Sterilization in place 在线灭菌Critical process parameter 关键工艺参数Visible particles 可见异物Pressure parameter 压力参数Process water 工艺用水Drinking water 饮用水Purified water 纯化水Water for injection (WFI) 注射用水Cooling / chilled water 冷冻水Pure steam 纯蒸汽Compressed air 压缩空气Activated carbon 活性炭Adsorbent temperature 吸附温度Circulating temperature 循环温度Pass box 传递窗Stainless steel nozzle 不锈钢喷嘴Vision glass 观察窗High strength hinge 高强度合页Pass window 传递窗Air handling panel 通风板Handle 把手Electronic interlock 电子互锁机构Primary meshed plate 初校网孔板Purification fan unit 净化风机Differential pressure gauge 压差表Intercom device 对讲机Ultraviolet lamp 紫外灯Unpowered roller 无动力滚筒Cleaning and sterilization 清洗灭菌Filter element 过滤器滤芯Visible foreign matters 可见异物Insoluble particles 不溶性微粒Autoclave 高压灭菌器Document 文件Record 记录Report 报告Vial washing machine 洗瓶机Vertical ultrasonic washing machine 立体超声波清洗机Cycle index 循环次数Sterilizing and drying 灭菌干燥Heated air circulation sterilizing oven 热风循环烘箱Tunnel sterilizing oven 隧道烘箱Suction blower 吸风机Laminar flow 层流Valve 阀门Plenum chamber 静压箱Air bellow 风箱、Surface air cooler 表冷器Net belt 网带Rubber stopper cleaning machine 胶塞清洗机Bacterial endotoxin 细菌内毒素Filling and partially stoppering 灌装和半加塞Filling machine 灌装机Content adjustment 装量调节Laminar flow protection 层流保护Content uniformity 装量差异Samples 样品Stoppering system 加塞系统Feeding system 上料系统Freeze-drying system 冻干系统Sublimation 升华Desorption 解吸附Freeze dryer /lyophilizer 冻干机Chamber 冻干箱Shelves 板层Condense 冷肼Hydraulic 液压Circulation system 循环系统Vacuum system 真空系统Control system 控制系统Refrigeration system 制冷系统Compressor 压缩机Condensor 冷凝器Expansion valve 膨胀阀Evaporator 蒸发器Oil pump 油泵Crankcase heater 曲轴箱加热器Intake port 吸气口Junction box 接线盒Flusher 喷洒装置Mameplate 名牌Safety valve 安全阀Vacuum gauge 真空计Electrical heater 电加热Plate heat exchanger 板式加热器Pressure gauge 压力表Relay 继电器Pneumatic ball valve 气动球阀Diaphragm valve 隔膜阀Rolling cover operation 扎盖Rolling-cover machine 轧盖机Turntable 转台Orbit 轨道Bottle distribution 理瓶Capping structure 压盖结构Main motor 主电机Operation panel 操作面板Loading & unloading system 进出料系统Artificial feeding system 人工上料系统Laminar car 层流车Battery container 蓄电池箱Universal wheel 万向轮Fan filter unit 风机过滤单元Barrier system 隔离系统Isolator 隔离器Glove box 手套箱Half suit 半身衣。
医药行业专业英语词汇
医药行业专业英语词汇（非常有用）FDA和EDQM术语: CLINICAL?TRIAL：临床试验? ANIMAL?TRIAL：动物试验? ACCELERATED?APPROVAL：加速批准? STANDARD?DRUG：标准药物? INVESTIGATOR：研究人员；调研人员PREPARING?AND?SUBMITTING：起草和申报? SUBMISSION：申报；递交? BENIFIT （S）：受益? RISK（S）：受害? DRUG?PRODUCT：药物产品? 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? ADVERSE?EFFECT：副作用? ADVERSE?REACTION：不良反应? PROTOCOL：方案? ARCHIVAL?COPY：存档用副本? REVIEW?COPY：审查用副本? OFFICIAL?COMPENDIUM：法定药典（主要指USP、?NF）．? USP （THE?UNITED?STATES?PHARMACOPEIA）：美国药典NF（NATIONAL?FORMULARY）：（美国）国家处方集? OFFICIAL＝PHARMACOPEIAL=?COMPENDIAL：药典的；法定的；官方的? AGENCY：审理部门（指FDA）? IDENTITY：真伪；鉴别；特性? STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）? LABELED?AMOUNT：标示量? REGULATORY?SPECIFICATION：质量管理规格标准（NDA提供）? REGULATORY?METHODOLOGY：质量管理方法? REGULATORY?METHODS?VALIDATION：管理用分析方法的验证COS/CEP?欧洲药典符合性认证ICH（International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of PharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。
制药行业专业英语
CPP marketing authorization (MAFDA Abbreviated New Drug Application (ANDA Number FDA active ingredient FDA ANDAFDA Approval HistoryFDA Approval LetterFDA Biologic License Application (BLAFDA Biologic ProductFDA Brand Name DrugFDA discontinued drugFDA Dockets Management System (DMSFDA dosage formFDA Dosage FormFDA drugFDA Drug ProductFDA DrugFDA FDA Action DateFDA FDA Application Number FDA Federal Registers (FRFDA Generic DrugFDA LabelFDA Marketing statusFDA medication guideFDA New Drug Application (NDA NumberFDA Over-the-Counter Drugs (OTCFDA Patient Package Insert (PPIFDA Pharmaceutical EquivalentsFDA Pre-NDA meetingFDA The CDER Data Standards Manual (The CDER DSMFDA the Center-wide Oracle Management Information System (COMISFDA the Developers and Distributors System (DADSFDA the Division Files System (DFSFDA the Drug Product Reference File (DPRFFDA the Drug Registration and Listing System (DRLSFDA the Federal Dockets Management System (FDMS FDA the Special Products On-Line Tracking System (SPOTS FDA the United States Adopted Names Council (USAN ICH Common Technical Document (CTDICH Electronic Common Technical Document (eCTDICH Expert Working Groups (EWGsICH Global Cooperation Group (GCGICH ICH guidelinesICH ICH steering committeeICH Impurities in New Drug ProductsICH International Federation of Pharmaceutical Manufacturers and Associations (IFPMAICH Terms of ReferenceICH the International Conference on Harmonisation (ICHICH-Q7A Active Pharmaceutical Ingredient (API(or Drug Substance ICH-Q7A API Starting MaterialICH-Q7A Batch (or LotICH-Q7A Batch Number (or Lot NumberICH-Q7A BioburdenICH-Q7A CalibrationICH-Q7A Computer SystemICH-Q7A Computerized SystemICH-Q7A ContaminationICH-Q7A Contract ManufacturerICH-Q7A CriticalICH-Q7A Cross-ContaminationICH-Q7A Drug (Medicinal ProductICH-Q7A Expiry Date (or Expiration DateICH-Q7A ImpurityICH-Q7A Impurity ProfileICH-Q7A In-Process Control (or Process Control REACH Agency(Central Agency REACH Animal testingREACH ArticleREACH authorisationREACH Business impact assessment (BIA REACH CMR物质REACH Competent AuthoritiesREACH Computer modellingREACH DeadlinesREACH Downstream usersREACH Endocrine disruptersREACH Epidemiological studiesREACH European Chemicals BureauREACH EvaluationREACH Existing chemicalsREACH ExposureREACH Globally Harmonised Syste (GHSREACH In vitro testringREACH Intergovernmental Forum on Chemicals Safety (IFCS REACH IntermediatesREACH New chemicalsREACH Persistent, Bio-accumulative and Toxic Chemicals REACH PolymersREACH POP物质REACH PPORDREACH PrepartionREACH Prior Informed Consent (PICREACH RegistrantREACH RegistrationREACH Registration, Evaluation and Authorization of Chemicals (European CommissionREACH RiskREACH Small and medium sized enterprises (SME REACH Substances in articlesREACH SubstitutionREACH Sustainable developmentREACH Technical Expert Working GroupsREACH Tonnage thresholdREACH United Nations Environment Programme (UNEP REACH very Persistent and very Bio-accumulative Chemicals保健品health food(s, functional food(s, dietary supplement(s保健品new resource food法律-比较case law法学法律-比较civil law system法学法律-比较common law法学法律-比较common law system法学法律-比较Comparative Law法学法律-比较Comprative Study of Law法学法律-比较legal doctrine法学法律-比较法学Legal System, Legal Family, Legal Group, Legal Genealogy, legal tradition法律-比较法学Study of Comprative Law公司类型Aktiengesellschaft (A.G.公司类型aktieselskab (丹麦文, aktieselskab(挪威文 (A/S公司类型Altiebolag (AB公司类型Berhad (BHD公司类型Besloten Vennootshap met beperkte aansprak-elijkhed (B.V.公司类型Gesellschaft Mit Beschrankter Haftung (GmbH公司类型Kabushiki Kaisha (K.K公司类型mPte, PVT公司类型Naamloze Vennootschap (N.V.公司类型Osakeyhtio (OY公司类型Perseroan Terbatas (PT公司类型Proprietary (MPTY公司类型Public Limited Company (PLC公司类型PVT, PTV公司类型SDN BHD公司类型Sendirian (ESDN公司类型Sociedad Anonima de Capital Variable (S.A. de C.V.公司类型societa a responsabilita limitata (SRL公司类型societa per azioni (SPA公司类型société à responsabilitéé limitée (S.A.R.L.公司类型Societe Anoym (法语, Societa Anonima (意大利语,Sociedad Anonima (西班牙语 (S.A.公司类型TBK 公司类型Yugen Kaisha (Y.K.机构Beaufour IPSEN (Tianjin Pharmaceutical Co., Ltd.,机构China Academy of Engineering Physics 机构China Association for Pharmaceutical Equipment (CAPE 机构China Council for the Promotion of International Trade (CCPIT机构China National Pharmaceutical Industry Corporation Ltd 机构Committee for Medicinal Products for Human Use (Centrale Humanitaire Médico-Pharmaceutique (CHMP机构Committee for Proprietary Medicinal Products (CPMP机构Ethypharm 机构European Directorate for the Quality of Medicines &HealthCare (EDQM机构European Medicines Evaluation Agency 机构European Public Assessment Report (EPAR机构Fournier Pharma 机构French Health Products Safety Agency (Agence française de sécurité sanitaire des produits de santé (AFSSAPS机构Insititute of Nuclear Physics and Chemistry 机构Joincare Pharmaceutical Group Industry Co.,Ltd.机构LAWSON MARDON PACKAGING BEIJING REPRESENTATIVE OFFICE 机构National Development and Reform Commission (NDRC机构National Institute for the Control of Pharmaceutical and Biological Products (NICPBP机构National Order of Pharmacists (Ordre Nationale des Pharmaciens (NOP机构North China pharmaceutical group corporation机构Pharmaceuticals and Medical Devices Evaluation(PMDEC机构Pharmacovigilance Working Party (PhVWP机构SCAS Ecoscience Technology Inc机构School of Pharmacy , Fudan University机构Second Military Medical University机构Shanghai Ethypharm Pharmaceutical Co., Ltd.机构Shanghai Institute for Food and Drug Control (SIFDC 机构Shanghai International Pharmaceutical Co. Ltd机构Tianjin Institute of Pharmaceutical Research (TIPR 机构TIPR Pharmaceutical.co.ltd机构Zuellig Pharma进口报验bills of lading进口报验certificate of origin进口报验invoices of freight进口报验packing lists进口报验purchase contract美国adulterated美国Caution,Federal law prohibits dispensing without prescription.美国caveat emptor美国Federal Trade Commission (FTC美国Food Chemicals Codex (FCC美国Journal of the American Medical Association美国misbranded美国Pharmaceutical Manufactures Association (PMA美国Rx美国1820U.S. Pharmacopeia (USP美国1836Patent Office美国1847American Medical Association (AMA美国1848Drug Importation Act美国1852American Pharmaceutical Association (APhA美国1862Chemical Division, U.S. Department of Agricalture Bureau 美国1888National Formulary美国1902Hygienic Table美国1902Poison Squad美国1906Pure Food and Drugs Act (PFDA, Wiley Act美国1912Sherley Amendment美国1938Food, Drugs, and Cosmetic Act (FDCA美国1951Prescription Drug Amendment, Durham-Humphrey Amendment美国1962Kefauver-Harris Amendments 欧盟European Community (EC欧盟European Federation of Pharmaceutical Industries and Associations (EFPIA 欧盟European Union (EU申请类型abbreviated new drug applications (ANDAs申请类型investigational new drug applications (INDs申请类型new drug applications (NDAs市场aging country市场blockbuster drug市场brand name drug, branded drug, innovator drug/ product市场Catalogue of State Basic Medical Insurance and Employment Injury Insurance Medicines市场compound annual growth rate (CAGR市场current preparations市场distributor市场first marketed市场first-line therapy市场Franchised Distributor市场gain popularity市场generic drug市场increase in popularity市场Industries Ltd.市场lag time市场market exclusivity市场market prospect市场marketing authorization (MA市场mental health市场off-label use;unapproved use市场patient compliance市场product pipeline市场regimen市场sales in revenue市场sales in volume市场Substance Abuse, Drug Abuse市场SWOT analysis - strength(优势,weakness(弱势, opportunity(机会,threat(威胁市场wholesale市场withdrawal syndrome外包Active Pharmaceutical Ingredients (API外包Contract Manufacturing Organization (CMO外包Contract Research Organization (CRO外包Outsourcing外包Pharmaceutical Development Services (PDS外包Pharmaceutical Resource Organization (PRO外包Trials Management Organization (TMO文件份数in decuplicate文件份数in duplicate文件份数in nonuplicate文件份数in octuplicate文件份数in quadruplicate文件份数in quintuplicate文件份数in septuplicate文件份数in sextuplicate文件份数in triplicate文献检索Abstract文献检索Catalog Number文献检索Postscript文献检索Report Author文献检索Report Title行政ASSISTANT COUNSEL行政ASSISTANT MINISTER行政ASSTANT CONSULTANT行政checker行政China International Consultancy Co.行政CLERK行政CONSULTANT行政COUNSEL行政DEPUTY DIRECTOR行政DEPUTY DIRECTOR(VICE-MINISTER行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY SECRETARY-GENERAL行政DEPUTY SECTION CHIEF行政DIRECTOR OF A DIVISION行政DIRECTOR(MINISTER行政DIRECTOR-GENERAL OF A BUREAU行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF THE GENERAL OFFICE 行政general director 行政MINISTER行政MINISTER行政MINISTRY OF THE PEOPLE’S REPUBLIC OF CHINA 行政OFFICE OF THE STATE COUNCIL行政PREMIER行政PRINCIPAL STAFF MEMBER行政responsible person行政SECRETARY-GENERAL行政SECTION CHIEF行政SENIOR STAFF MEMBER行政senior vice president行政STAFF MEMBER行政STATE COMMISSION OF THE PEOPLE’S REPUBLIC OF CHINA行政STATE COUNCILLOR行政VICE-MINISTER行政VICE-MINISTER行政VICE-PREMIER行政文件all illegal medical practices 行政文件approval notification行政文件classified management of medical organizations; medical institutions classification administration行政文件draft for comment行政文件Drug Catalogue of National Basic Medical Insurance 行政文件drug production/ manufacture and distribution行政文件government guidance price/ pricing行政文件government price/ pricing行政文件health administrative departments/ authorities行政文件healthcare system reform行政文件illegal medical practice行政文件macro administration行政文件medical expenses行政文件medical institution行政文件medical insurance行政文件medical personnel行政文件medical service quality行政文件medical services行政文件preferential tax policies; tax privileges; favorable tax policies行政文件price monopoly行政文件price protection行政文件professional conduct; professional ethics行政文件reasonably priced行政文件rectify e conduct of medical personnel行政文件remain practically unchanged行政文件resources allocation行政文件socialist market economy行政文件supervision行政文件supervision system行政文件the basic medical insurance system for urban employees 行政文件the Central Party Committee行政文件the State Council行政文件urban employees研发Immediate Release Solid Oral Dosage Forms:Scale-Up and Post Approval Changes(SUPAC研发In-house R&D 研发Licensing研发Merge研发Modified Release Solid Oral Dosage Forms:Scale-Up and Post Approval Changes(SUPAC-MR研发Pharmaceutical Development Services (PDS研发Pharmaceutical R&D Sponsor研发Pharmaceutical Resource Organization (PRO研发Trials Management Organization (TMO医改affordable medicines医改be managed at both central and provincial levels 医改cost structure医改differential pricing医改differentiation-pricing医改during the period of protection医改economic evaluation医改financial expense医改industrial policies医改level of innovation医改list of essential drugs (EDL医改management expense医改parity-pricing医改period cost, period expense 医改policy maker医改price医改price structure医改product mix医改provincial government医改sales expense, selling expense医改sales profit rate医改sales profits医改state essential drugs医改the competent pricing department of the State Council 医改the Provincial People’s Government医改uniform pricing医改unprofitable medical institution印度Drugs & Cosmetics Act, 1940中国Chinese Dietary Reference Intakes (DRIs中国Chinese Pharmacopoeia (Ch P中国Good Agricultural Practice (GAP中国the National Standard of the People's Republic of China (GB 5749-85 “Hygienic Standard of Living Drinking Water注册申请表affix the official seal注册申请表after examination注册申请表Chinese Pharmacopoeia Commission注册申请表Chinese Phonetic Alphabet, Pinyin注册申请表contact person, person to be contacted注册申请表drug approval number注册申请表Drug Manufacturing License注册申请表examining authority注册申请表formulation composition注册申请表indication category注册申请表indications or functions注册申请表is in perfect accordance with注册申请表mailing address, contact address注册申请表monitoring period of new drugs注册申请表new drug certificate注册申请表Notification of Approval Opinion注册申请表official approvals of the research proposal 注册申请表official seal 注册申请表organization code注册申请表patent declaration注册申请表patent information注册申请表position注册申请表products of the same drug by other enterprises注册申请表psycho-neurological注册申请表quantitative composition of the unit formula 注册申请表registered address注册申请表registration category注册申请表shall not be altered专利Patent Cooperation Treaty (PCT专利prior art专利priority date专利withdraw×× department above the municipal level where it is located1906 Pure Food and Drugs Acta seal card for purchase of sthabove the municipal levelacceptance notificationaccommodate remarks and explanationsAcquisitionactive ingredientactive moietyactive partactive pharmaceutical ingredient (API, active ingredient(AI, drug substance, bulk drugsAcute Toxicityadditional sheetsadjust the classification of precursor chemicals or to add any other type other than those as prescribed in the present Regulations within its administrative jurisdiction administration departments at all levelsadministrative department for industry and commerce administrative protectionadverse drug reaction reportingAir Waybill (AWBall the people's governments at or above the county level Alliance,PartnershipAmendmentAmerican Medical AssociationAmerican Pharmaceutical AssociationAmerican Society of Hospital Pharmacistsan internal management system for precursor chemicals anabolic steroids, anabolic-androgenic steroids (AAS anabolic hormonesAnalytical MethodApplication For Registrationapplication pendingapproval numberapproved informationAs discussed at the FDA Pre-NDA meetingAsean Common Technical Document (ACTD autonomous regionBased on the requirement to ensure public health, SFDA may implement a monitoring period for the approved new drugs so as to continue to monitor the safety of the new drug. The drug-monitoring period shall start from the date of approval for production, and shall not exceed 5 years. For the new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises.batch certificationbatch releasebe chemically described asbe involved in one of the steps of the finished product manufacturingbe submitted in typefacebe up to (the standard, conform to, comply with biologicsbiologics license applications (BLAs biopharmaceuticsblood productsbrand name, trade namebrand-name drugBureau of Biological and Physical SciencesBureau of ChemistryBUREAU OF FOOD AND DRUGS (BFAD Business Address of Applicantbusiness scopebuy at wholesale and sell at retailCarcinogenicitycase sesitiveCaution: Federal law prohibits dispensing without prescriptionCenters for Disease Control and Prevention (CDC certificate of incorporationcertificate of its need for legal useCertificate of Suitability for European Pharmacopeia (COS / CEPCertificates of Product Registration (CPR Certification Committee for Drugs (CCD certifying authoritycheck, auditChemical Structurechemical APIsChemical Unitchemically reactive substanceChemistry, Manufacturing, and Controls (CMC Chief ChemistChinese materia medicaChinese traditional patent medicineChronic ToxicityciryCitizens Advisory Committeecity divided into districtsclassified administrationClinic Trialcntinuation sheetsCode of Federal Regulations (CFR combination of active ingredientscome into the marketcommercial company (CCcommercially availablecompetent authoritycompetent commerce departmentcompetent communications department competent environmental protection department competent health departmentcompetent national authoritycompetent pricing departmentcompetent railway departmentcomplete the submission-for-the-record formalities compound drugs containing ephedrine alkaloids compound preparationconsistencycontact addresscontact personcontainerContract Manufacturing Organization (CMO Contract Research Organization (CRO contractual partiescorporate identity numbercost, insurance and freight (CIFcountry of origincurrent Good Manufacturing Practice (cGMP direct contactdirect lineDivision of Penicillin Control and Immunology dosagedosage formdosage forms intended for oral administrationdosedraft guidancedrug approval numberdrug classification systemDrug Inspection LaboratoryDrug Master File (DMFdrug precursor, drug precursor chemicalsdrug productdrug registration specificationsdrug retailerearly Marcheffective as ofefficaciousefficacyempirical formulaentrusted purchaseEssential Oils Laboratoryessentially similar productestablish a ledger for sale of sthEuropean Directorate for the Quality of Medicines & HealthCare (EDQMexamination and approvalexcludeExp. Date, shelf lifeexplanatory notesExport QuantityExport RegionFDA(Food and Drug AdministrationFDAMAFederal Food, Drug and Cosmetic Act Federal Trade CommissionFeeding Trialfinished productfixed dose combination (FDCFood, Drug and Insecticide Administrationfor the purpose of inspectionformulationFrench Health Products Safety Agency (Afssaps from the date of salefront-line workersgeneral informationgeneral instructionsgeneric druggeneric nameglobal clinical trialGood Practices applicable to the manufacture of medicinal products and to their quality controlguidelinesHak Atas Kekayaan Intelektual (IndonesiaHatch-Waxman法案headed notepaperICH guidelineICH harmonised tripartite guidelineIf the tip-off turns out to be true, the people's government at or above the county level and the relevant competent administrative department shall award the relevant informant.illegal activitiesillegal productionillegally produceImport CoastImport Drug License (IDLin all other casesin commercial packingin duplicateindustrial estateinformationinspectionintended useIntermediateInternational Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICHInternational Nonproprietary Name (INN Investigational Drug BrochureIPissue the certificateJudicature ActLaboratory ErrorLaboratory Investigationlarge medical equipmentlaw enforcementlaw enforcement officials laws, regulations and rules lawyer's letterledgerlegal representativelegallizelicensed pharmacistlotMagna Cartamaintenance of records mandatory planmanufacturemanufacturing processmarket supply and demand marketing authorization marketing authorization holder medical technologymedicinal productmedicinal products for human useMemorandum of Understandingme-too drugMfg dateMft.Timeminimum packageMinistry of Health (MOHmislabeled and adulterated drugs and foodmunicipalitymunicipality directly under the Central Government Mutagenicitymutually exclusiveName of ApplicantNames of Countries in Which Registered/Marketed National Center for Health Inspection and Supervision national drug standardnational drug standardsNational Institute for the Control of Pharmaceutical and Biological Products (nicpbpnational legislationnational non-proprietary namenational regulatory authoritiesNo designated production enterprise of ephedrine shall expand the production scale of ephedrine in the form of technology transfer, joint management or establishing branch plant without the approval of the state department of pharmaceutical administration.nonprescription drug, Over The Counter (OTCNon-Steroidal Anti-Inflammatory Drug (NSAIDnot applicablenot availablenotarial certificatenotarizationnotarizenotification, circularOffice of Drug AdministrationOffice of Drug ControlOffice of Food ControlOffice of Special Collaborative Investigations off-patent drug, patent expired drugOriginal SampleOrphan Drug ActOrphan drug, Orphan Medicinal ProductOut of Specification (OOSoverpriceoverstaffPackage Size(sPackage Insert (PIpacking listpacking listpacking sizepatent medicinespatent protectionPatent Protection Association of China (PPAC patient information leaflet Patient Information Leaflet (PILpeptide hormonesPerson In Charge (PICpharma gradePharmaceutical Data Management Systemspharmaceutical formspharmaceutical preparationpharmaceutical preparationsPharmacological TestPharmacological Laboratorypharmacopoeial methodpharmacovigilance (PVPhysical and Chemical Propertiespollutant disposal facilitiespower of attorney (POA, letter of attorneyprepared plan for environmental emergenciesprepared sliceprepared slices of Chinese crude drugsprescription drugs, ethical drug, Rxprimary stability batchesProduct ManualProduction Informationproduction enterprise of chemical productsProduction/Marketing Approval Documents Manufacture of Production/GMP CertificateProprietary nameprovide recommendations to sbprovinceprovision(sPTOPublic HealthPublic Health Codepublic securitypurchase and sale contractpurchaser qualificationPVT. LTD.qualificationqualification documentsQuality StandardsQuantitative CompositionReanalysisrecommended nutriednt intake (RNIrecord of drug-related crimesReference/Chemical Reference Substance registered address registrantregistration dossierRegulations for Administration of Precursors and Chemicals used in Production of Narcotic Drugs and Psychotropic Substanceregulatory specificationreleaserelease datereport identifierReproductionre-registrationResampleResiduerestricted materialRetestsafe intakesafe production management systemsale unitsales networkSecretary of Health, Education, and Welfareself-manufacturedset up a sales officeShaanxi Hanjiang Pharmaceutical Group Co., Ltd Shanghai Pharmaceutical Professional Association site master file (SMF, plane master file (PMF small and medium sized enterprises (SME smugglespecial precautionsspecifyspecifystandardizationState Administration of Traditional Chinese Medicine (SATCMStorageStrengthStrengthSubacute Toxicitysubmission-for-the-record, for the recordsubstances frequently uesd in the illicit manufacture of narcotic drugs and psychotropic substances, precursor chemicalsSummary of Product CharacteristicsSummary of Product Characteristics (SPCSummary of Product Characteristics(SPCSummary of Product Characteristics(SPC supervision and inspection on sthsupervisory and administrative department of safe productionSupplemental NDAsSupplementary ApplicationSwiss Federal Health OfficesynonymSynthetic Products LaboratoryTECH GRADEtechnical dataTechnical Examination MeetingTechnical Reports SeriesTeratogenicitytest for releasethe American Society for Testing and Materials (ASTM the applicant (for sth in the exporting countrythe Chemical Abstracts Service (CASthe conditions of delievery and useThe department that receives a tip-off shall keep secret the relevant informant.the early part of the month, the first ten days of the month The European Agency for the Evaluation of Medicinal Products ( EMEAthe first month in the quarterthe format recommended by the WHOthe General Administration of Customsthe International Organization for Standardization (ISO The manufacture license is revoked in accordance with the law.the National Drug Code Number (NDC Numberthe National Institutes of Standards and Technology (NIST The Pediatric Exclusivity Provisionthe State Councilthe status of the medicinal productThe United States Pharmacopoeial Convention, USP Conventionto whom it may concernto-be-marketed drug producttoll manufactureToxicological Testtrade dresstrademarktrade-secrettropical diseasestruthfully recordtype of applicationU. S. Public Health Service(USPHS unwritten rulesupper- and lower-caseuse ledgervalidated methodviolate the criminal law, a crime is constituted warehouse facilitiesWhere there is any of the following circumstances WHO International Conference of Drug Regulatory Authorities (WHO-ICDRAwholesalewrapperwrit同比上市许可FDA的解释:This six digit number is assigned by FDA staff to eachapplication for approval to market a generic drug in the United States.FDA的解释:An active ingredient is any component that providespharmacological activity or other direct effect in the diagnosis, cure, mitigation,treatment, or prevention of disease, or to affect the structure or any function of FDA 的解释:An Abbreviated New Drug Application (ANDA contains datathat, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal and clinical (human data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.FDA的解释:The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA. There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.FDA的解释:An official communication from FDA to a new drug application (NDA sponsor that allows the commercial marketing of the product.FDA的解释:Biological products are approved for marketing under the provisions of the Public Health Service (PHS Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for theproduct. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.FDA的解释:A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries. Biologic products are a subset of "drug products" distinguished by their manufacturing processes (biological process vs. chemical process. In general, the term "drugs" includes biologic products.FDA的解释:A brand name drug is a drug marketed under a proprietary, trademark-protected name.FDA的解释:A discontinued drug is a drug product that has been removed from the market in the United States for reasons other than safety or effectiveness.后改为the Federal Dockets Management System (FDMSA dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.。
制药行业专业英语
CPP marketing authorization (MA)FDA Abbreviated New Drug Application (ANDA) Number FDA active ingredientFDA ANDAFDA Approval HistoryFDA Approval LetterFDA Biologic License Application (BLA)FDA Biologic ProductFDA Brand Name DrugFDA discontinued drugFDA Dockets Management System (DMS)FDA dosage formFDA Dosage FormFDA drugFDA Drug ProductFDA DrugFDA FDA Action DateFDA FDA Application Number FDA Federal Registers (FR)FDA Generic DrugFDA LabelFDA Marketing statusFDA medication guideFDA New Drug Application (NDA) NumberFDA Over-the-Counter Drugs (OTC)FDA Patient Package Insert (PPI)FDA Pharmaceutical EquivalentsFDA Pre-NDA meetingFDA The CDER Data Standards Manual (The CDER DSM)FDA the Center-wide Oracle Management Information System (COMIS)FDA the Developers and Distributors System (DADS)FDA the Division Files System (DFS)FDA the Drug Product Reference File (DPRF)FDA the Drug Registration and Listing System (DRLS)FDA the Federal Dockets Management System (FDMS) FDA the Special Products On-Line Tracking System (SPOTS) FDA the United States Adopted Names Council (USAN) ICH Common Technical Document (CTD)ICH Electronic Common Technical Document (eCTD)ICH Expert Working Groups (EWGs)ICH Global Cooperation Group (GCG)ICH ICH guidelinesICH ICH steering committeeICH Impurities in New Drug ProductsICH International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)ICH Terms of ReferenceICH the International Conference on Harmonisation (ICH)ICH-Q7A Active Pharmaceutical Ingredient (API)(or Drug Substance) ICH-Q7A API Starting MaterialICH-Q7A Batch (or Lot)ICH-Q7A Batch Number (or Lot Number)ICH-Q7A BioburdenICH-Q7A CalibrationICH-Q7A Computer SystemICH-Q7A Computerized SystemICH-Q7A ContaminationICH-Q7A Contract ManufacturerICH-Q7A CriticalICH-Q7A Cross-ContaminationICH-Q7A Drug (Medicinal) ProductICH-Q7A Expiry Date (or Expiration Date)ICH-Q7A ImpurityICH-Q7A Impurity ProfileICH-Q7A In-Process Control (or Process Control) REACH Agency（Central Agency）REACH Animal testingREACH ArticleREACH authorisationREACH Business impact assessment (BIA) REACH CMR物质REACH Competent AuthoritiesREACH Computer modellingREACH DeadlinesREACH Downstream usersREACH Endocrine disruptersREACH Epidemiological studiesREACH European Chemicals BureauREACH EvaluationREACH Existing chemicalsREACH ExposureREACH Globally Harmonised Syste (GHS)REACH In vitro testringREACH Intergovernmental Forum on Chemicals Safety (IFCS) REACH IntermediatesREACH New chemicalsREACH Persistent， Bio-accumulative and Toxic Chemicals REACH PolymersREACH POP物质REACH PPORDREACH PrepartionREACH Prior Informed Consent (PIC)REACH RegistrantREACH RegistrationREACH Registration, Evaluation and Authorization of Chemicals (European Commission)REACH RiskREACH Small and medium sized enterprises (SME) REACH Substances in articlesREACH SubstitutionREACH Sustainable developmentREACH Technical Expert Working GroupsREACH Tonnage thresholdREACH United Nations Environment Programme (UNEP) REACH very Persistent and very Bio-accumulative Chemicals保健品health food(s), functional food(s), dietary supplement(s)保健品new resource food法律-比较case law法学法律-比较civil law system法学法律-比较common law法学法律-比较common law system法学法律-比较Comparative Law法学法律-比较Comprative Study of Law法学法律-比较legal doctrine法学法律-比较法学Legal System, Legal Family, Legal Group, Legal Genealogy, legal tradition法律-比较法学Study of Comprative Law公司类型Aktiengesellschaft (A.G.)公司类型aktieselskab (丹麦文), aktieselskab(挪威文) (A/S)公司类型Altiebolag (AB)公司类型Berhad (BHD)公司类型Besloten Vennootshap met beperkte aansprak-elijkhed (B.V.)公司类型Gesellschaft Mit Beschrankter Haftung (GmbH)公司类型Kabushiki Kaisha (K.K)公司类型mPte, PVT公司类型Naamloze Vennootschap (N.V.)公司类型Osakeyhtio (OY)公司类型Perseroan Terbatas (PT)公司类型Proprietary (MPTY)公司类型Public Limited Company (PLC)公司类型PVT, PTV公司类型SDN BHD公司类型Sendirian (ESDN)公司类型Sociedad Anonima de Capital Variable (S.A. de C.V.)公司类型societa a responsabilita limitata (SRL)公司类型societa per azioni (SPA)公司类型société à responsabilitéé limitée (S.A.R.L.)公司类型Societe Anoym (法语), Societa Anonima (意大利语),Sociedad Anonima (西班牙语) (S.A.)公司类型TBK 公司类型Yugen Kaisha (Y.K.)机构Beaufour IPSEN (Tianjin) Pharmaceutical Co., Ltd.,机构China Academy of Engineering Physics 机构China Association for Pharmaceutical Equipment （CAPE ）机构China Council for the Promotion of International Trade (CCPIT)机构China National Pharmaceutical Industry Corporation Ltd 机构Committee for Medicinal Products for Human Use （Centrale Humanitaire Médico-Pharmaceutique ）(CHMP)机构Committee for Proprietary Medicinal Products (CPMP)机构Ethypharm 机构European Directorate for the Quality of Medicines &HealthCare (EDQM)机构European Medicines Evaluation Agency 机构European Public Assessment Report (EPAR)机构Fournier Pharma 机构French Health Products Safety Agency (Agence française de sécurité sanitaire des produits de santé) （AFSSAPS)机构Insititute of Nuclear Physics and Chemistry 机构Joincare Pharmaceutical Group Industry Co.,Ltd.机构LAWSON MARDON PACKAGING BEIJING REPRESENTATIVE OFFICE 机构National Development and Reform Commission (NDRC)机构National Institute for the Control of Pharmaceutical and Biological Products (NICPBP)机构National Order of Pharmacists （Ordre Nationale des Pharmaciens ）(NOP)机构North China pharmaceutical group corporation机构Pharmaceuticals and Medical Devices Evaluation(PMDEC)机构Pharmacovigilance Working Party (PhVWP)机构SCAS Ecoscience Technology Inc机构School of Pharmacy , Fudan University机构Second Military Medical University机构Shanghai Ethypharm Pharmaceutical Co., Ltd.机构Shanghai Institute for Food and Drug Control (SIFDC)机构Shanghai International Pharmaceutical Co. Ltd机构Tianjin Institute of Pharmaceutical Research (TIPR)机构TIPR Pharmaceutical.co.ltd机构Zuellig Pharma进口报验bills of lading进口报验certificate of origin进口报验invoices of freight进口报验packing lists进口报验purchase contract美国adulterated美国Caution，Federal law prohibits dispensing withoutprescription.美国caveat emptor美国Federal Trade Commission (FTC)美国Food Chemicals Codex （FCC)美国Journal of the American Medical Association美国misbranded美国Pharmaceutical Manufactures Association (PMA)美国Rx美国1820U.S. Pharmacopeia (USP)美国1836Patent Office美国1847American Medical Association (AMA)美国1848Drug Importation Act美国1852American Pharmaceutical Association (APhA)美国1862Chemical Division, U.S. Department of Agricalture Bureau 美国1888National Formulary美国1902Hygienic Table美国1902Poison Squad美国1906Pure Food and Drugs Act (PFDA), Wiley Act美国1912Sherley Amendment美国1938Food, Drugs, and Cosmetic Act (FDCA)美国1951Prescription Drug Amendment, Durham-Humphrey Amendment美国1962Kefauver-Harris Amendments 欧盟European Community (EC)欧盟European Federation of Pharmaceutical Industries and Associations (EFPIA)欧盟European Union (EU)申请类型abbreviated new drug applications (ANDAs)申请类型investigational new drug applications (INDs)申请类型new drug applications (NDAs)市场aging country市场blockbuster drug市场brand name drug, branded drug, innovator drug/ product市场Catalogue of State Basic Medical Insurance and Employment Injury Insurance Medicines市场compound annual growth rate （CAGR)市场current preparations市场distributor市场first marketed市场first-line therapy市场Franchised Distributor市场gain popularity市场generic drug市场increase in popularity市场Industries Ltd.市场lag time市场market exclusivity市场market prospect市场marketing authorization (MA)市场mental health市场off-label use；unapproved use市场patient compliance市场product pipeline市场regimen市场sales in revenue市场sales in volume市场Substance Abuse, Drug Abuse市场SWOT analysis - strength(优势)，weakness(弱势)，opportunity(机会)，threat(威胁)市场wholesale市场withdrawal syndrome外包Active Pharmaceutical Ingredients (API)外包Contract Manufacturing Organization (CMO)外包Contract Research Organization (CRO)外包Outsourcing外包Pharmaceutical Development Services (PDS)外包Pharmaceutical Resource Organization (PRO)外包Trials Management Organization (TMO)文件份数in decuplicate文件份数in duplicate文件份数in nonuplicate文件份数in octuplicate文件份数in quadruplicate文件份数in quintuplicate文件份数in septuplicate文件份数in sextuplicate文件份数in triplicate文献检索Abstract文献检索Catalog Number文献检索Postscript文献检索Report Author文献检索Report Title行政ASSISTANT COUNSEL行政ASSISTANT MINISTER行政ASSTANT CONSULTANT行政checker行政China International Consultancy Co.行政CLERK行政CONSULTANT行政COUNSEL行政DEPUTY DIRECTOR行政DEPUTY DIRECTOR（VICE-MINISTER）行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY DIRECTOR-GENERAL行政DEPUTY SECRETARY-GENERAL行政DEPUTY SECTION CHIEF行政DIRECTOR OF A DIVISION行政DIRECTOR（MINISTER）行政DIRECTOR-GENERAL OF A BUREAU行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF A DEPARTMENT行政DIRECTOR-GENERAL OF THE GENERAL OFFICE 行政general director行政MINISTER行政MINISTER行政MINISTRY OF THE PEOPLE’S REPUBLIC OF CHINA 行政OFFICE OF THE STATE COUNCIL行政PREMIER行政PRINCIPAL STAFF MEMBER行政responsible person行政SECRETARY-GENERAL行政SECTION CHIEF行政SENIOR STAFF MEMBER行政senior vice president行政STAFF MEMBER行政STATE COMMISSION OF THE PEOPLE’S REPUBLIC OF CHINA行政STATE COUNCILLOR行政VICE-MINISTER行政VICE-MINISTER行政VICE-PREMIER行政文件all illegal medical practices 行政文件approval notification行政文件classified management of medical organizations; medical institutions classification administration行政文件draft for comment行政文件Drug Catalogue of National Basic Medical Insurance 行政文件drug production/ manufacture and distribution行政文件government guidance price/ pricing行政文件government price/ pricing行政文件health administrative departments/ authorities行政文件healthcare system reform行政文件illegal medical practice行政文件macro administration行政文件medical expenses行政文件medical institution行政文件medical insurance行政文件medical personnel行政文件medical service quality行政文件medical services行政文件preferential tax policies; tax privileges; favorable tax policies行政文件price monopoly行政文件price protection行政文件professional conduct; professional ethics行政文件reasonably priced行政文件rectify e conduct of medical personnel行政文件remain practically unchanged行政文件resources allocation行政文件socialist market economy行政文件supervision行政文件supervision system行政文件the basic medical insurance system for urban employees 行政文件the Central Party Committee行政文件the State Council行政文件urban employees研发Immediate Release Solid Oral Dosage Forms：Scale-Up and Post Approval Changes（SUPAC）研发In-house R&D 研发Licensing研发Merge研发Modified Release Solid Oral Dosage Forms：Scale-Up and Post Approval Changes（SUPAC-MR）研发Pharmaceutical Development Services （PDS)研发Pharmaceutical R&D Sponsor研发Pharmaceutical Resource Organization （PRO)研发Trials Management Organization （TMO)医改affordable medicines医改be managed at both central and provincial levels 医改cost structure医改differential pricing医改differentiation-pricing医改during the period of protection医改economic evaluation医改financial expense医改industrial policies医改level of innovation医改list of essential drugs (EDL)医改management expense医改parity-pricing医改period cost, period expense 医改policy maker医改price医改price structure医改product mix医改provincial government医改sales expense, selling expense医改sales profit rate医改sales profits医改state essential drugs医改the competent pricing department of the State Council 医改the Provincial People’s Government医改uniform pricing医改unprofitable medical institution印度Drugs & Cosmetics Act, 1940中国Chinese Dietary Reference Intakes (DRIs)中国Chinese Pharmacopoeia (Ch P)中国Good Agricultural Practice （GAP)中国the National Standard of the People's Republic of China （GB 5749-85 “Hygienic Standard of Living Drinking Water）注册申请表affix the official seal注册申请表after examination注册申请表Chinese Pharmacopoeia Commission注册申请表Chinese Phonetic Alphabet, Pinyin注册申请表contact person, person to be contacted注册申请表drug approval number注册申请表Drug Manufacturing License注册申请表examining authority注册申请表formulation composition注册申请表indication category注册申请表indications or functions注册申请表is in perfect accordance with注册申请表mailing address, contact address注册申请表monitoring period of new drugs注册申请表new drug certificate注册申请表Notification of Approval Opinion注册申请表official approvals of the research proposal 注册申请表official seal注册申请表organization code注册申请表patent declaration注册申请表patent information注册申请表position注册申请表products of the same drug by other enterprises注册申请表psycho-neurological注册申请表quantitative composition of the unit formula注册申请表registered address注册申请表registration category注册申请表shall not be altered专利Patent Cooperation Treaty (PCT)专利prior art专利priority date专利withdraw×× department above the municipal level where it islocated1906 Pure Food and Drugs Acta seal card for purchase of sthabove the municipal levelacceptance notificationaccommodate remarks and explanationsAcquisitionactive ingredientactive moietyactive partactive pharmaceutical ingredient (API), active ingredient(AI), drug substance, bulk drugsAcute Toxicityadditional sheetsadjust the classification of precursor chemicals or to add any other type other than those as prescribed in the present Regulations within its administrative jurisdiction administration departments at all levelsadministrative department for industry and commerce administrative protectionadverse drug reaction reportingAir Waybill (AWB)all the people's governments at or above the county level Alliance，PartnershipAmendmentAmerican Medical AssociationAmerican Pharmaceutical AssociationAmerican Society of Hospital Pharmacistsan internal management system for precursor chemicals anabolic steroids, anabolic-androgenic steroids (AAS) anabolic hormonesAnalytical MethodApplication For Registrationapplication pendingapproval numberapproved informationAs discussed at the FDA Pre-NDA meetingAsean Common Technical Document (ACTD) autonomous regionBased on the requirement to ensure public health, SFDA may implement a monitoring period for the approved new drugs so as to continue to monitor the safety of the new drug. The drug-monitoring period shall start from the date of approval for production, and shall not exceed 5 years. For the new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises.batch certificationbatch releasebe chemically described asbe involved in one of the steps of the finished product manufacturingbe submitted in typefacebe up to (the standard), conform to, comply with biologicsbiologics license applications (BLAs) biopharmaceuticsblood productsbrand name, trade namebrand-name drugBureau of Biological and Physical SciencesBureau of ChemistryBUREAU OF FOOD AND DRUGS (BFAD) Business Address of Applicantbusiness scopebuy at wholesale and sell at retailCarcinogenicitycase sesitiveCaution: Federal law prohibits dispensing without prescriptionCenters for Disease Control and Prevention (CDC) certificate of incorporationcertificate of its need for legal useCertificate of Suitability for European Pharmacopeia （COS / CEP)Certificates of Product Registration (CPR) Certification Committee for Drugs (CCD) certifying authoritycheck, auditChemical Structurechemical APIsChemical Unitchemically reactive substanceChemistry, Manufacturing, and Controls （CMC) Chief ChemistChinese materia medicaChinese traditional patent medicineChronic ToxicityciryCitizens Advisory Committeecity divided into districtsclassified administrationClinic Trialcntinuation sheetsCode of Federal Regulations （CFR）combination of active ingredientscome into the marketcommercial company (CC)commercially availablecompetent authoritycompetent commerce departmentcompetent communications department competent environmental protection department competent health departmentcompetent national authoritycompetent pricing departmentcompetent railway departmentcomplete the submission-for-the-record formalities compound drugs containing ephedrine alkaloids compound preparationconsistencycontact addresscontact personcontainerContract Manufacturing Organization （CMO) Contract Research Organization （CRO) contractual partiescorporate identity numbercost, insurance and freight (CIF)country of origincurrent Good Manufacturing Practice (cGMP) direct contactdirect lineDivision of Penicillin Control and Immunology dosagedosage formdosage forms intended for oral administrationdosedraft guidancedrug approval numberdrug classification systemDrug Inspection LaboratoryDrug Master File (DMF)drug precursor, drug precursor chemicalsdrug productdrug registration specificationsdrug retailerearly Marcheffective as ofefficaciousefficacyempirical formulaentrusted purchaseEssential Oils Laboratoryessentially similar productestablish a ledger for sale of sthEuropean Directorate for the Quality of Medicines & HealthCare (EDQM)examination and approvalexcludeExp. Date, shelf lifeexplanatory notesExport QuantityExport RegionFDA（Food and Drug Administration）FDAMAFederal Food, Drug and Cosmetic ActFederal Trade CommissionFeeding Trialfinished productfixed dose combination (FDC)Food, Drug and Insecticide Administrationfor the purpose of inspectionformulationFrench Health Products Safety Agency (Afssaps)from the date of salefront-line workersgeneral informationgeneral instructionsgeneric druggeneric nameglobal clinical trialGood Practices applicable to the manufacture of medicinal products and to their quality controlguidelinesHak Atas Kekayaan Intelektual (Indonesia)Hatch-Waxman法案headed notepaperICH guidelineICH harmonised tripartite guidelineIf the tip-off turns out to be true, the people's government at or above the county level and the relevant competent administrative department shall award the relevant informant.illegal activitiesillegal productionillegally produceImport CoastImport Drug License (IDL)in all other casesin commercial packingin duplicateindustrial estateinformationinspectionintended useIntermediateInternational Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) (ICH)International Nonproprietary Name （INN) Investigational Drug BrochureIPissue the certificateJudicature ActLaboratory ErrorLaboratory Investigationlarge medical equipmentlaw enforcementlaw enforcement officialslaws, regulations and ruleslawyer's letterledgerlegal representativelegallizelicensed pharmacistlotMagna Cartamaintenance of recordsmandatory planmanufacturemanufacturing processmarket supply and demandmarketing authorizationmarketing authorization holdermedical technologymedicinal productmedicinal products for human useMemorandum of Understandingme-too drugMfg dateMft．Timeminimum packageMinistry of Health （MOH)mislabeled and adulterated drugs and foodmunicipalitymunicipality directly under the Central Government Mutagenicitymutually exclusiveName of ApplicantNames of Countries in Which Registered/Marketed National Center for Health Inspection and Supervision national drug standardnational drug standardsNational Institute for the Control of Pharmaceutical and Biological Products (nicpbp)national legislationnational non-proprietary namenational regulatory authoritiesNo designated production enterprise of ephedrine shall expand the production scale of ephedrine in the form of technology transfer, joint management or establishing branch plant without the approval of the state department of pharmaceutical administration.nonprescription drug, Over The Counter (OTC)Non-Steroidal Anti-Inflammatory Drug (NSAID)not applicablenot availablenotarial certificatenotarizationnotarizenotification, circularOffice of Drug AdministrationOffice of Drug ControlOffice of Food ControlOffice of Special Collaborative Investigations off-patent drug, patent expired drugOriginal SampleOrphan Drug ActOrphan drug, Orphan Medicinal ProductOut of Specification (OOS)overpriceoverstaffPackage Size(s)Package Insert (PI)packing listpacking listpacking sizepatent medicinespatent protectionPatent Protection Association of China (PPAC) patient information leafletPatient Information Leaflet (PIL)peptide hormonesPerson In Charge (PIC)pharma gradePharmaceutical Data Management Systemspharmaceutical formspharmaceutical preparationpharmaceutical preparationsPharmacological TestPharmacological Laboratorypharmacopoeial methodpharmacovigilance (PV)Physical and Chemical Propertiespollutant disposal facilitiespower of attorney (POA), letter of attorneyprepared plan for environmental emergenciesprepared sliceprepared slices of Chinese crude drugsprescription drugs, ethical drug, Rxprimary stability batchesProduct ManualProduction Informationproduction enterprise of chemical productsProduction/Marketing Approval Documents Manufacture of Production/GMP CertificateProprietary nameprovide recommendations to sbprovinceprovision(s)PTOPublic HealthPublic Health Codepublic securitypurchase and sale contractpurchaser qualificationPVT. LTD.qualificationqualification documentsQuality StandardsQuantitative CompositionReanalysisrecommended nutriednt intake (RNI)record of drug-related crimesReference/Chemical Reference Substance registered addressregistrantregistration dossierRegulations for Administration of Precursors and Chemicals used in Production of Narcotic Drugs and Psychotropic Substanceregulatory specificationreleaserelease datereport identifierReproductionre-registrationResampleResiduerestricted materialRetestsafe intakesafe production management systemsale unitsales networkSecretary of Health, Education, and Welfareself-manufacturedset up a sales officeShaanxi Hanjiang Pharmaceutical Group Co., Ltd Shanghai Pharmaceutical Professional Association site master file (SMF), plane master file (PMF) small and medium sized enterprises (SME) smugglespecial precautionsspecifyspecifystandardizationState Administration of Traditional Chinese Medicine （SATCM）StorageStrengthStrengthSubacute Toxicitysubmission-for-the-record, for the recordsubstances frequently uesd in the illicit manufacture of narcotic drugs and psychotropic substances, precursor chemicalsSummary of Product CharacteristicsSummary of Product Characteristics (SPC)Summary of Product Characteristics(SPC)Summary of Product Characteristics(SPC) supervision and inspection on sthsupervisory and administrative department of safe productionSupplemental NDAsSupplementary ApplicationSwiss Federal Health OfficesynonymSynthetic Products LaboratoryTECH GRADEtechnical dataTechnical Examination MeetingTechnical Reports SeriesTeratogenicitytest for releasethe American Society for Testing and Materials (ASTM) the applicant (for sth) in the exporting countrythe Chemical Abstracts Service (CAS)the conditions of delievery and useThe department that receives a tip-off shall keep secret the relevant informant.the early part of the month, the first ten days of the month The European Agency for the Evaluation of Medicinal Products （ EMEA)the first month in the quarterthe format recommended by the WHOthe General Administration of Customsthe International Organization for Standardization (ISO) The manufacture license is revoked in accordance with the law.the National Drug Code Number (NDC Number)the National Institutes of Standards and Technology (NIST) The Pediatric Exclusivity Provisionthe State Councilthe status of the medicinal productThe United States Pharmacopoeial Convention, USP Conventionto whom it may concernto-be-marketed drug producttoll manufactureToxicological Testtrade dresstrademarktrade-secrettropical diseasestruthfully recordtype of applicationU. S. Public Health Service（USPHS）unwritten rulesupper- and lower-caseuse ledgervalidated methodviolate the criminal law, a crime is constituted warehouse facilitiesWhere there is any of the following circumstances WHO International Conference of Drug Regulatory Authorities (WHO-ICDRA)wholesalewrapperwrit同比上市许可FDA的解释：This six digit number is assigned by FDA staff to eachapplication for approval to market a generic drug in the United States.FDA的解释：An active ingredient is any component that providespharmacological activity or other direct effect in the diagnosis, cure, mitigation,treatment, or prevention of disease, or to affect the structure or any function of FDA的解释：An Abbreviated New Drug Application (ANDA) contains datathat, when submitted to FDA's Center for Drug Evaluation and Research, Officeof Generic Drugs, provides for the review and ultimate approval of a genericdrug product. Generic drug applications are called "abbreviated" because theyare generally not required to include preclinical (animal) and clinical (human)data to establish safety and effectiveness. Instead, a generic applicant mustscientifically demonstrate that its product is bioequivalent (i.e., performs in thesame manner as the innovator drug). Once approved, an applicant maymanufacture and market the generic drug product to provide a safe, effective,low cost alternative to the American public.FDA的解释：The approval history is a chronological list of all FDA actionsinvolving one drug product having a particular FDA Application number(NDA). There are over 50 kinds of approval actions including changes in thelabeling, a new route of administration, and a new patient population for a drugproduct.FDA的解释：An official communication from FDA to a new drug application(NDA) sponsor that allows the commercial marketing of the product.FDA的解释：Biological products are approved for marketing under theprovisions of the Public Health Service (PHS) Act. The Act requires a firm whomanufactures a biologic for sale in interstate commerce to hold a license for theproduct. A biologics license application is a submission that contains specificinformation on the manufacturing processes, chemistry, pharmacology, clinicalpharmacology and the medical affects of the biologic product. If the informationprovided meets FDA requirements, the application is approved and a license isissued allowing the firm to market the product.FDA的解释：A biologic product is any virus, serum, toxin, antitoxin, vaccine,blood, blood component or derivative, allergenic product, or analogous productapplicable to the prevention, treatment, or cure of diseases or injuries. Biologicproducts are a subset of "drug products" distinguished by their manufacturingprocesses (biological process vs. chemical process). In general, the term "drugs"includes biologic products.FDA的解释：A brand name drug is a drug marketed under a proprietary,trademark-protected name.FDA的解释：A discontinued drug is a drug product that has been removedfrom the market in the United States for reasons other than safety oreffectiveness.后改为the Federal Dockets Management System (FDMS)A dosage form is the physical form in which a drug is produced and dispensed,such as a tablet, a capsule, or an injectable.FDA的解释：A dosage form is the physical form in which a drug is producedand dispensed, such as a tablet, a capsule, or an injectable.。
制药行业GMP英文词汇
Approve 批准Artwork 药品标签Authorized Person,AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test,FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance,QA 质量保证Qualification 确认Qualified Person,QP 质量受权人Quality Agreement 质量协议Quality Control,QC 质量控制Quality Management,QM 质量管理Quality review 质量审核Quality Unit,QU/Quality Operations, QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test,SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature signed 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。
制药行业常用英语
Cross-Contamination：交叉污染（一种物料或产品对另一种物料或产品的污染）
Deviation：偏差（对批准的指令或规定的标准的偏离0
Drug (Medicinal) Product:药品(经最后包装准备销售的制剂－参见Q1A)
Batch (or Lot):批由一个或一系列工艺过程生产的一定数量的物料，因此在规定的限度内是均一的。在连续生产中，一批可能对应于与生产的某一特定部分。其批量可规定为一个固定数量，或在固定时间间隔内生产的数量。
Batch Number (or Lot Number):批号
用于标识一批的一个数字、字母和/或符号的唯一组合，从中可确定生产和销售的历史。
Process Aids：工艺辅料除溶剂外，在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如，助滤剂、活性炭)。Production：生产
在原料药制备过程中，从接收原料，到工艺加工和原料药包装所涉及的所有操作。
Qualification：确认证明设备或辅助系统，安装正确、工作正常、确实产生预期的结果，并以文件佐证。确认是验证的一部分，但单独的确认步骤不构成工艺验证。
Reference Standard, Secondary：二级参考标准品
与基准参考标准品比较显示具有规定的质量和纯度，并用作日常实验室分析的参考标准品。
Reprocessing：返工将不符合标准或规格的一个中间体或原料药返回工艺过程，重复规定的生产工艺中的某一结晶步骤或其它合适的化学或物理处理步骤(如蒸馏，过滤，层析，磨粉)，这种做法通常是可以接受的。在中间控制的测试表明一工艺步骤没有完成，从而继续该步骤，是正常工艺的一部分，而不是返工。
制药行业GMP英文词汇
制药行业G M P英文词汇标准化管理处编码[BBX968T-XBB8968-NNJ668-MM9N]Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。
制药行业英语词汇汇编
Oral solid dosage form / Oral solid preparation 口服固体制剂Materials [mə'tɪərɪəlz]物料，材料Raw materials 原辅料Starting materials 起始物料Packing materials 包装材料Active pharmaceutical ingredient API [,fɑːmə'suːtɪk(ə)l; -'sjuː-]原料ingredient [ɪn'griːdɪənt] n. 原料；要素；组成部分adj. 构成组成部分的Excipient , adjuvant 辅料excipient [ik'sipint] n. 【药物】赋形剂adjuvant ['ædʒʊv(ə)nt] n. [药] 佐药；助理员adj. 辅助的Diluents 稀释剂Fillers 填充剂Starch 淀粉starch [stɑːtʃ]Dextrin 糊精dextrin ['dekstrɪn]Lactose 乳糖lactose ['læktəʊz; -s]Moistening agent , humectant [hjʊ'mekt(ə)nt]润湿剂Adhesive , binder 粘合剂[əd'hiːsɪv; -zɪv]Ethanol['eθənɒl]乙醇Disintegrants disintegrant [dɪs'ɪntɪɡrənt] 崩解剂Lubricant ['luːbrɪk(ə)nt]润滑剂Glidants 助流剂Antiadherent 抗粘剂Talc [tælk] 滑石粉Intermediates 中间体Finished product 最终成品Supper 供应商Distributor 分销商Manufacturer [,mænjʊ'fæktʃ(ə)rə(r)] 生产商Audit ['ɔːdɪt]审计Tablet 片剂Granules [grænju:ls]颗粒剂Capsules 胶囊剂Powder 散剂Pills 丸剂Compressed tablet 普通片Coated tablet 包衣片Sugar coated tablet 糖衣片Film coated tablet 薄膜衣片Enteric coated tablet 肠溶衣片Effervescent tablet [efə'vesənt]泡腾片Chewable tablet 咀嚼片Dispersible tablet 分散片Sustained release tablet 缓释片Controlled release tablet 控释片Multilayer tablet ['mʌltɪleɪə]多层片Manufacturing process 生产工艺Milling / grinding ['graɪndɪŋ]碾碎Sifting 过筛Dispensing 配料Blending ['blendɪŋ]混合Granulating / granulation [,ɡrænjʊ'leɪʃən]成粒，制粒Drying 干燥Tablet compression 压片compression [kəm'preʃ(ə)n] n. 压缩，浓缩；压榨，压迫Dedust [di:'dʌst]除尘Coating 包衣Polish ['pɒlɪʃ] 抛光Dies arrangement 配模arrangement [ə'reɪn(d)ʒm(ə)nt] n. 布置；整理；准备dies ['daii:z] n. [机] 模具（名词die的复数）；（拉）日n. (Dies)人名；(英)戴斯；(西)迭斯v. 死亡；消失（动词die的第三人称单数形式）；凋谢Packing 包装Bottle washing 洗瓶Bottle drying 烘瓶Packaging 包装，打包Labeling 贴签Filling 填充，灌装Capsule shell 胶囊壳shell [ʃel]n. 壳，贝壳；炮弹；外形vt. 剥皮；炮轰vi. 剥落；设定命令行解释器的位置Blister packing 起泡包装Inner packing material 内包材Outer packing material 外包材Whole test 全检Weight 重量Fineness 细度，粒度Particle size 粒度Loss on drying 干燥失重Content 含量Disintegration 崩解度Dissolution 溶出度Appearance 外观Quality 质量Quantity 数量Equipment / facility / apparatus / device 设备Process step 工艺步骤Weighing & dispensing 称配Granulation 制粒Compression 压片Coating 包衣Capsule filling 胶囊填充Batch production instruction / order 批生产指令Standard operation procedure 标准操作规程Formulation 处方Verification 确认，检定Calibration 校准Qualification 确认Validation 验证Authentication 认证Weighing cover 称重罩Weighting box 称重柜Balance 天平Electronic platform scale 电子台秤Vibrating sieve 振荡筛Mesh 网眼Grinder / pulverizer 粉碎机Inlet 进料口Steel tooth 钢齿Annular sieve plate 换装筛板Outlet 出粉口Charging hole 加料口Horizontal shaft 水平轴Shaking device 抖动装置Air bleeding pocket 放气袋Wet granulation 湿法制粒Dry granulation 干法制粒Spray granulation 喷雾制粒Mixing granulator 混合制粒机Pneumatic lid-opening device 启动开盖装置Cutting motor 切割电机Cooling water enters 冷却水进口Air admission orifice 进气管口Cooling water out 冷却水出口Touch screen 触摸屏Stirring motor 搅拌电机Power supply 电源Compressed air source 压缩空气源Controller 控制器Cutting knife 造粒刀Drum lid 桶盖Drum 盛料筒Discharge hole 出料口Stirrer 搅拌器Driving belt 传送皮带Machine base 机座Fluid bed granulator 流化床制粒机Hot air circulating oven 热风循环烘箱Heater 加热器Fan 风扇Filter gauze 滤网Mixing machine 混合机Quality test 质量检查Weight difference 片重差异Hardness 硬度Rigidity 脆碎度Rotary tablet press 旋转式压片机Die 冲模Punch 冲头Upper punch 上冲Upper pinch roller 上压轮Filling support 填充架Powder scraper 刮粉器Die 模圈Lower punch 下冲Tablet weight adjuster 片中调节器Lower pinch roller 下压轮ourlet adjuster 出片调节器coating 包衣isolated layer 隔离层sub-coating layer 粉衣层sugar-coating layer 糖衣层colored sugar-coating layer 有色糖衣层polishing 打光coating machine / coater 包衣机sidedoor 侧门upper box 上箱体lower box 下箱体airtight chamber 密闭工作室coating platen 包衣滚筒big sprocket 大链轮tensioner 涨紧轮cycle chain 链条washing pan 清洗盘small sprocket 小链轮electromotor 电动机capsule filling machine 胶囊填充机adjusting screw 填充杆调节螺钉upper die-set 上模架column 立柱powder loop 盛粉环metering plate 计量盘lock screw 锁紧螺钉fixed screw 固定螺钉gland flange 压板scale 标尺cover 盖板filling bar 填充杆powder scraper 刮粉器hopper 胶囊料斗liner bearing 直线轴承fork slider 拨叉滑块sliding valve 滑动门阀knob 旋钮baffle 挡板fastening screw 紧固螺钉order fork 顺序叉shifting fork 胶囊拨叉inverted trough 胶囊导槽lyophilized products / freeze drying preparation 冻干产品personnel 人员equipment 设备materials 物料regulations 法规environment 环境cross-contamination 交叉污染positive pressure 正压negative pressure 负压weighing room 称量室downflow booth 垂直层流工作室fan drive system 风机驱动系统HEPA filterHigh efficiency particulate air filter 高效过滤器Bleed air 排风Containment zone 控制区Background environment 背景环境Clean area 洁净区Grade A BUnclean area 一般区Differential pressure 压差Air speed 风速Temperature 温度Humidity 湿度Electronic balance 电子天平Operation keys 操作键Display with backlight 背光显示屏Model plate 型号标牌Draft shield element 放风圈Weighing pan 秤盘Draft shield 防风罩Leveling feet 水平调节脚Hager 秤钩AC adapter socket 交流电源适配器插座Interface 接口Solution preparation 配液Thick preparation 浓配Thin preparation 稀配Tanks for solution preparation 配液灌Sight glass 视镜Hatch 人孔Liquid level meter 液位计Liquid outlet 出液口Condensate water 冷凝水Steam inlet 蒸汽入口Automatic control 自动化控制Sterile filtration 无菌过滤Clean in place 在线清洗Sterilization in place 在线灭菌Critical process parameter 关键工艺参数Visible particles 可见异物Pressure parameter 压力参数Process water 工艺用水Drinking water 饮用水Purified water 纯化水Water for injection (WFI) 注射用水Cooling / chilled water 冷冻水Pure steam 纯蒸汽Compressed air 压缩空气Activated carbon 活性炭Adsorbent temperature 吸附温度Circulating temperature 循环温度Pass box 传递窗Stainless steel nozzle 不锈钢喷嘴Vision glass 观察窗High strength hinge 高强度合页Pass window 传递窗Air handling panel 通风板Handle 把手Electronic interlock 电子互锁机构Primary meshed plate 初校网孔板Purification fan unit 净化风机Differential pressure gauge 压差表Intercom device 对讲机Ultraviolet lamp 紫外灯Unpowered roller 无动力滚筒Cleaning and sterilization 清洗灭菌Filter element 过滤器滤芯Visible foreign matters 可见异物Insoluble particles 不溶性微粒Autoclave 高压灭菌器Document 文件Record 记录Report 报告Vial washing machine 洗瓶机Vertical ultrasonic washing machine 立体超声波清洗机Cycle index 循环次数Sterilizing and drying 灭菌干燥Heated air circulation sterilizing oven 热风循环烘箱Tunnel sterilizing oven 隧道烘箱Suction blower 吸风机Laminar flow 层流Valve 阀门Plenum chamber 静压箱Air bellow 风箱、Surface air cooler 表冷器Net belt 网带Rubber stopper cleaning machine 胶塞清洗机Bacterial endotoxin 细菌内毒素Filling and partially stoppering 灌装和半加塞Filling machine 灌装机Content adjustment 装量调节Laminar flow protection 层流保护Content uniformity 装量差异Samples 样品Stoppering system 加塞系统Feeding system 上料系统Freeze-drying system 冻干系统Sublimation 升华Desorption 解吸附Freeze dryer /lyophilizer 冻干机Chamber 冻干箱Shelves 板层Condense 冷肼Hydraulic 液压Circulation system 循环系统Vacuum system 真空系统Control system 控制系统Refrigeration system 制冷系统Compressor 压缩机Condensor 冷凝器Expansion valve 膨胀阀Evaporator 蒸发器Oil pump 油泵Crankcase heater 曲轴箱加热器Intake port 吸气口Junction box 接线盒Flusher 喷洒装置Mameplate 名牌Safety valve 安全阀Vacuum gauge 真空计Electrical heater 电加热Plate heat exchanger 板式加热器Pressure gauge 压力表Relay 继电器Pneumatic ball valve 气动球阀Diaphragm valve 隔膜阀Rolling cover operation 扎盖Rolling-cover machine 轧盖机Turntable 转台Orbit 轨道Bottle distribution 理瓶Capping structure 压盖结构Main motor 主电机Operation panel 操作面板Loading & unloading system 进出料系统Artificial feeding system 人工上料系统Laminar car 层流车Battery container 蓄电池箱Universal wheel 万向轮Fan filter unit 风机过滤单元Barrier system 隔离系统Isolator 隔离器Glove box 手套箱Half suit 半身衣。
制药行业常用英语(中英文对照版)
制药行业常用英语1、药品生产质量管理规范GMP：Good ManufacturingPractice2、国家食品与药品监督管理局State Food andDrug Administration3、总则GeneralProvisions4、《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Preparation6、原料药API: Active PharmaceuticalIngredient7、成品finished goods8、工序process9、机构与人员organization and personnel10、专业知识professional knowledge11、生产经验production experience12、组织能力organizational skill13、技术人员technical staff14、实施implementation15、药品生产pharmaceutical manufacturing 16、质量管理quality management17、质量检验quality inspection18、专业技术培训professional and technicaltraining 19、基础理论知识basic theoreticalknowledge20、实际操作技能practical operationskills 21、高生物活性highly potent22、高毒性high toxicity23、污染contamination24、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 level28、昆虫insect29、洁净室（区）clean room(area)30、光滑smooth31、无裂缝no cracks32、无颗粒物脱落no particle shedding 33、耐受endure34、消毒disinfection35、无菌sterile36、交界处junction, joint37、弧形arc38、灰尘积聚dues accumulation 39、储存区store area40、生产规模production scale 41、设备equipment42、物料material43、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tuber48、公用设施, 公用工程utilities of publicservice 49、照明lighting50、照度illumination51、应急紧急情况emergency52、净化purification, clean53、微生物, 微生物学, 微生物的micro-organism, microbiology,microbiologic 54、监测monitoring55、记录record56、天棚天花板ceiling, roof57、密封seal58、静压差Static DifferentialPressure 59、温度temperature60、相对湿度RH: Relative Humidity 61、低漏地漏floor drainer62、青霉素penicillin63、分装室separating room, fillingroom64、相对负压relative negativepressure65、废气waste gas,exhausted air66、β－内酰胺结构类药品β-Lactasestructure drug, drugs of β-Lactic group67、避孕药品contraceptives68、激素类hormone69、抗肿瘤类anti-tumor, oncology70、放射性药品Radiopharmaceuticals71、包装packing, package72、循环使用recycling73、微粒particles74、辐射radiation, irradiation75、细菌bacteria76、病毒virus77、细胞cell78、脱毒前后pre and post detoxification 79、活疫苗与灭活疫苗active vaccine/inactivatedvaccine 80、人血液制品blood products 81、预防制品prevention products82、灌装filling83、中药Chinesetraditional medicines 84、前处理pretreatment85、提取extraction86、浓缩concentration87、动物脏器viscera of animal,organ of animal 88、蒸、炒、炙、煅steaming, frying,sunburn, testing 89、炮制concocted90、通风ventilation91、除烟smoke removal92、除尘dust removal93、降温设施temperature-reducingestablishment, cooling94、筛选screening, sift95、切片slicing96、粉碎grinding97、压缩空气compressed air98、惰性气体noble gas99、取样Sampling100、称量室weighing room, dispensingroom 101、中药标本Chinese herbal sample,exemplar of TCM 102、检定鉴定verification, identification 103、同位素Isotope104、设备equipment105、选型model/type selection 106、耐腐蚀anticorrosion107、吸附adsorption, absorption 108、润滑剂, 润滑lubricant, lubricate 109、冷却剂coolant110、流向flow direction111、纯化水PW: Purified Water 112、注射用水WFI: Water for Injection 113、滋生breeding114、储罐tank115、死角neglected portion 116、盲管blind pipe117、纤维fiber118、疏水性hydrophobicity119、仪表instrumentation 120、量具measuring tool 121、衡器weighing instrument 122、精密度precision123、维修、保养maintenance 124、不合格disqualified reject 125、物料material126、购买purchasing127、发放releasing128、产地origin129、入库loading130、固体solid131、液体liquid132、挥发性volatile133、净药材net medicine, netTCM 134、麻醉药品narcotics135、精神药品psychotropic drug 136、易燃combustible137、易爆explosive138、验收acceptance139、使用说明书instruction140、标签label 141、卫生, 清洁/消毒sanitation142、车间, 辅房workshop143、间隔时间time interval144、清洁剂detergent145、消毒剂disinfectant146、废弃物wastes147、更衣室changing room148、工作服,work clothes149、颗粒性物质, 颗粒剂granules150、耐药菌株drug-resistant strain151、传染病infectiousdisease152、皮肤病dermatitis153、验证verification, validation 154、确认qualification155、安装installation156、运行running operation 157、性能performance158、原辅料raw material and incipient 159、文件document160、投诉complaint 161、报废reject162、品名product name163、处方preion, formula164、技术参数technicalparameter165、容器container166、半成品semi-finished product,intermediate167、申请application168、稳定性stability169、起草draft170、生产管理production management,manufacturing control.171、事故accident172、混淆mix-up173、喷雾spray174、合格证certificate175、清场clearance176、质量管理quality management 177、内控internal control,on-line test 178、滴定液tartan179、培养基medium180、有效期validity, expiry 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complaints and adversereaction 183、自检self-inspection184、附则schedule appendix185、平衡balance186、饮用水drinking water, potablewater 187、蒸馏法distillation188、离子交换法ion exchange189、反渗透法RO: Reverse Osmosis190、附加剂添加剂additives191、滞留stranded resort192、批batch, lot193、组分, 组成component194、无纤维脱落的过滤器non-fiber-releasingfilter195、活性成份Active Ingredient196、非活性成份Inactive ingredient197、中间产品in-process product,intermediate product 198、批号batch number199、药用物料medicated feed200、药用预混合料medicated premix 201、质量控制部门Quality control department 202、理论产量Theoretical yield203、实际产量Actual yield204、比率Percentage, rate205、验收标准可接受标准Acceptance criteria206、代表性样品Representative sample 207、微粒状的particulate208、污染物contaminant209、石棉asbestos210、诊断diagnosis211、缓解mitigation212、化学变化chemical change 213、组分ingredient, component 214、制备fabricate preparation 215、复合compound216、混合blend217、加工processing218、浓度concentration219、单位剂量unit dose220、药品包装容器drug product containers 221、密封件, 封盖closure222、效价Titer223、纯度purity224、规格strength225、监督supervise, monitor226、实验室laboratory227、无菌操作aseptic operation,sterile operation 228、层流laminar flow229、湍流turbulent air flow230、空气过滤air filtration231、空气加热air heating 232、预过滤器profiler233、排气系统exhaust system 234、管件plumbing 235、虹吸倒流back-siphon age 236、污水sewage237、废料refuse238、盥洗设备toilet facilities 239、空气干燥器air drier240、垃圾trash 241、有机废料organic waste242、杀鼠剂rodenticides243、杀昆虫剂insecticides244、杀真菌剂fungicides245、熏蒸剂fumigating reagents246、去垢剂cleaning agents247、消毒剂sanitizing agents248、滂沱剂lubricant249、自动化设备、机械化设备和电子设备automatic, mechanical,or electronic equipment 250、微型胶卷microfilm251、注射剂injection252、灭菌设备sterilization equipment 253、无菌取样技术aseptic sampling techniques 254、显微镜microscope255、热源, 内毒素pyrogen, endotoxin256、偏差deviation257、变更change control258、进料charge-in259、项目代码item code260、鉴别identify 261、片剂tablet262、胶囊capsule263、颗粒剂granule264、溶解时间溶出时间dissolution time265、澄明度clarity266、隔离系统quarantinesystem, isolation system 267、返工reprocessing268、发放issuance, release269、非处方药OTC:over-the-counter270、处方药preed medicine271、皮肤科药、牙粉、胰岛素、喉片dermatological, dentifrice,insulin, or throat lozenge product272、保险包装tamper-resistant package273、明胶硬胶囊hard gelatin capsule274、顺势治疗homeopathic275、入库warehousing276、变质deteriorate277、准确性accuracy278、灵敏性sensitivity279、特异性specificity280、重复性reproducibility, repeatability 281、变应原提取物allergenic extracts282、眼膏ophthalmic ointment283、粗糙或磨蚀物质harsh or abrasivesubstances 284、控释制剂controlled-releasedosage form 285、实验动物laboratory animals286、供应商Supplier287、光谱spectrum288、测量单位units of measure289、换算系数conversion factors290、试剂reagent291、安慰剂placebo292、明确地explicitly293、取代supersede294、溶液solution295、批准approval296、(美国)食品药品监督管理局FDA: Food and DrugAdministration 297、标准操作程序SOP: Standard OperatingProcedure 298、质量保证QA: Quality Assurance299、质量控制QC:Quality Control300、批生产记录BPR: Batch ProductionRecord 301、批检验记录BAR: Batch AnalysisRecord302、工艺规程PP: Process Procedure303、健康,安全,环保EHS: Environment,Health and Safe 304、美国联邦法规CFR: Code of FederalRegulation 305、美国药典USP: The United StatesPharmacopeia 306、欧洲药典EP: European pharmacopeia307、英国药典BP: British pharmacopeia308、药物主文件DMF: Drug Master File309、验证主计划VMP: Validation MasterPlan310、验证方案VP: Validation Protocol311、验证报告VR: Validation Report312、安装确认IQ: Installation Qualification 313、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 product317、工厂主述文件SMF: Site Master File。
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小优优医药化工资源网» 认证交流» 一些英语词汇总结2006-8-29 14:35 tlcau一些英语词汇总结FDA（ Food and drug administration ）：（美国国家）食品药品品管理局IND（ Investigation 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）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U．S．Public Health Service：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所Clinical trial：临床试验Animal trial：动物试验Accelerated approval：加速批准Standard drug：标准药物Investigator：研究人员；调研人员Preparing and Submitting：起草和申报Submission：申报；递交Benefit（S）：受益Risk (S）：受害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Archival copy：存档用副本Review copy：审查用副本Official compendium：法定药典（主要指USP、 NF）．USP（The united states Pharmacopeia）：美国药典（现已和NF合并一起出版）NF（National formulary）：（美国）国家药品集OFFICIAL＝Pharmacopeia = COMPENDIAL：药典的；法定的；官方的Agency：审理部门（指FDA等）Sponsor：主办者（指负责并着手临床研究者）Identity：真伪；鉴别；特性Strength：规格；规格含量（每一剂量单位所含有效成分的量）Labeled amount：标示量Regulatory specification：质量管理规格标准（NDA提供）Regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）Regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）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 Human Use)人用药物注册技术要求国际协调会议Acceptance Criteria: 接收标准 (接收测试结果的数字限度、范围或其它合适的量度标准)Active Pharmaceutical Ingredient (API) (or Drug Substance): 活性药用成分 (原料药)旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。
此种物质在疾病的诊断，治疗，症状缓解，处理或疾病的预防中有药理活性或其它直接作用，或者能影响机体的功能和结构。
API Starting Material: 原料药的起始物料用在原料药生产中的，以主要结构单元被并入该原料药的原料、中间体或原料药。
原料药的起始物料可能是在市场上有售，能够根据合同或商业协议从一个或多个供应商处购得，或者自己生产。
原料药的起始物料通常有特定的化学特性和结构。
Batch (or Lot): 批由一个或一系列工艺过程生产的一定数量的物料，因此在规定的限度内是均一的。
在连续生产中，一批可能对应于与生产的某一特定部分。
其批量可规定为一个固定数量，或在固定时间间隔内生产的数量。
Batch Number (or Lot Number): 批号用于标识一批的一个数字、字母和/或符号的唯一组合，从中可确定生产和销售的历史。
Bioburden: 生物负载可能存在于原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类(例如，致病的或不致病的)。
生物负载不应当当作污染，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 : 计算机系统设计安装用于执行某一项或一组功能的一组硬件元件和关联的软件。
Computerized System: 计算机化系统 (与计算机系统整合的一个工艺或操作)Contamination: 污染在生产、取样、包装或重新包装、贮存或运输过程中，具化学或微生物性质的杂质或外来物质进入或沾染原料、中间体或原料药。
Contract Manufacturer ：合同制造商 (代表原制造商进行部分制造的制造商)Criteria：标准用来描述为了确保原料药符合规格标准，必须控制在预定范围内的工艺步骤、工艺条件、测试要求或其它有关参数或项目。
Cross-Contamination：交叉污染（一种物料或产品对另一种物料或产品的污染）Deviation：偏差（对批准的指令或规定的标准的偏离0Drug (Medicinal) Product: 药品 (经最后包装准备销售的制剂－参见Q1A)Expiry Date (or Expiration Date)：有效期原料药容器/标签上注明的日期，在此规定时间内，该原料药在规定条件下贮存时，仍符合规格标准，超过这一期限则不应当使用。
Impurity：杂质（存在于中间体或原料药中，任何不希望得到的成分）Impurity Profile：杂质概况（对存在于一种原料药中的已知和未知杂质的描述）In-Process Control (or Process Control)：中间控制，工艺控制生产过程中为监测、在必要时调节工艺和/或保证中间体或原料药符合其规格而进行的检查。
Intermediate：中间体原料药工艺步骤中产生的、必须经过进一步分子变化或精制才能成为原料药的物料。
中间体可以分离或不分离。
(注：只涉及该公司定义为原料药生产起始点以后生产的中间体。
)Manufacture：制造物料的接收、原料药的生产、包装、重新包装、贴签、重新贴签、质量控制、放行、贮存和分发以及相关控制的所有操作。
Material：物料原料(起始物料，试剂，溶剂)，工艺辅助用品，中间体，原料药和包装及贴签材料的统称。
Mother Liquor：母液结晶或分离后剩下的残留液。
母液可能含有未反应的物料、中间体、不同级别的原料药和/或杂质。
它可用于进一步加工。
Packaging Material：包装材料（在储运过程中保护中间体或原料药的任何物料）Procedure：程序对要进行的操作、采取的预防措施及与原料药或中间体生产直接或间接相关的方法的描述。
Process Aids：工艺辅料除溶剂外，在原料药或中间体生产中起辅助作用、本身不参与化学或生物学反应的物料(例如，助滤剂、活性炭)。
Production：生产在原料药制备过程中，从接收原料，到工艺加工和原料药包装所涉及的所有操作。
Qualification：确认证明设备或辅助系统，安装正确、工作正常、确实产生预期的结果，并以文件佐证。
确认是验证的一部分，但单独的确认步骤不构成工艺验证。
Quality Assurance (QA)：质量保证确保所有原料药达到其应用所要求的质量，并维持质量体系为目的的全部组织安排的总和。
Quality Control：质量控制（是否符合质量规格的检查或测试）Quality Unit(s) ：质量部门独立于生产部门的履行质量保证和质量控制职责的组织机构。
按照组织机构的大小和结构，可以是单独的QA 和QC部门，或个人，或小组。
Quarantine：待验在实物上或以其它有效方式将物料隔离，等待对其随后的批准或拒收做出决定的状态。
Raw Material：原料用来表示中间体或原料药的生产中要用的起始物料、试剂和溶剂的通用专业名词。
Reference Standard, Primary：基准参考标准品经广泛分析测试表明具有可信的高纯度的物质。
这类标准品可以：1)来源于法定的机构，2)独立合成，3)来自于高纯度的现有生产物料，或4)用进一步精制现有生产物料的方法来制备。
Reference Standard, Secondary ：二级参考标准品与基准参考标准品比较显示具有规定的质量和纯度，并用作日常实验室分析的参考标准品。
Reprocessing：返工将不符合标准或规格的一个中间体或原料药返回工艺过程，重复规定的生产工艺中的某一结晶步骤或其它合适的化学或物理处理步骤 (如蒸馏，过滤，层析，磨粉)，这种做法通常是可以接受的。