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1、生产工艺常用词汇:中文单硫酸卡那霉素硫酸氢钠枸橼酸钠硫酸溶液中性硼玻璃安瓿瓶安瓿瓶清洗Kan amyci n sulfatesodium bisulfatesodium citrate英文Sulfuric acid soluti onNeutral borosilicate glass ampouleAmpoule washi ngAmpouledepyroge nati onsterilizati onand安瓿瓶火菌除热源配料过滤灌封火菌和检漏测试灯检贴签和包装关键工艺参数升温段传送带压差时间间隔过滤器孔径Batch ingFiltrati onFilli ng and seali ngS
2、terilization and leakage testVisual / Lamp in spect ionLabeli ng and packag ingCritical Process Parameterheati ng sect ioncon veyor beltDifferen tial pressureTime in tervalPore size of filter过滤压力灌装量缓冲罐灌装前充氮保护灌装后充氮保护真空检漏测试内包材Filtrati on pressureFilli ng volumebuffer tankpre-fill ing n itroge n flushp
3、ost-filli ng n itroge n overlayVacuum leak testPrimary packaging materialProcess in structio nLivz onGroupFuzhouFux ingPharmaceutical Co. Ltd.Hunan Erka ng Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGuan gzhou Chemical Reage nt FactoryZhuhai Da Lin Wan In dustrial Gas Co.,LtdSCHOTT Gl
4、ass Tech nologies (Suzhou)Co. Ltdquality specificati onCirculati on waterRotati ng speedQC 常用英文词汇中文物理性状外观不溶性微粒溶液颜色鉴别保留时间含量有关物质标小量可见异物无菌薄膜过滤法内毒素英文Physical attributesAppeara neeParticulate matterSoluti on colorIde ntificati onretention timeAssayRelated substa neelabeled amountVisible particlesSterilit
5、yMembrane filtration methodBacterial en dotox insIn itial bioburde nstirring uniformityashy toppoin ted endbubble head, flat head, broke n ampoule, crookedampoule, empty ampoule;中文药品生产质量管理规范国家食品与药品监督管理局总则制剂原料药成品工序机构与人员专业知识生产经验组织能力技术人员英文GMP: Good ManufacturingPracticeState Food and Drug Administratio
6、nGen eral Provisi onspreparati onAPI: Active Pharmaceuticalfini shedgoodsprocessorga ni zatio n andpers onnelIn gredie ntprofessi onalkno wledgeproducti onexperie neeorga ni zati onalskilltech ni cal staff实施药品生产质里官理质里检验专业技术培训基础理论知识实际操作技能高生物活性咼毒性污染考核评估厂房与设施生产环境空气洁净级别昆虫洁净室（区）光滑无裂缝无颗粒物脱落耐受消毒impleme nta
7、ti onpharmaceuticalmanu facturi ngquality man ageme ntqualityin spect ionprofessionaland technicalknowledgetrainingbasic theoreticalpractical operati on skillshighlypote nthigh toxicitycon tam in ati onassessme ntbuildi ngs and facilitiesproducti onen viro nmentclean air levelin sectclean room(area)
8、smoothno cracksno particle sheddingtolera needis in fecti on无菌交界处弧形灰尘积聚储存区生产规模设备物料中间产品待验品交叉污染管道公用设施照明照度应急，紧急情况净化微生物，微生物学，微生物的监测记录天棚sterilejunction, jointarcdust accumulationstore areaproducti on scaleequipme ntmaterialin termediateproductquara nti nedmaterialcross-c on tam in ati onpipeli neutilitie
9、s of public servicelightingillumi natio nemerge ncypurificati on,clea nmicrobiology,microbiologicmicro-orga nism,mon itori ngrecord天花板ceili ng, roof密封静压差温度相对湿度地漏分装室相对负压废气sealStatic DifferentialtemperatureRH: Relative Humidityfloor dra inerseparati ngroom,filli ng roomPressurerelativen egativepressur
10、ewaste gas, exhausted airB内酰胺结构类药品避孕药品激素类抗肿瘤类放射性药品包装循环使用微粒辐射细菌病毒细胞脱毒前后3-Lactams structure drugcon traceptiveshorm onean ti-tumor,on cologyRadiopharmaceuticalspack ing, packagerecycli ngparticlesradiati onbacteriaviruscellPre-detoxificationand postdetoxification活疫苗与灭活疫苗人血液制品预防制品灌装中药前处理提取浓缩动物脏器炮制通风除烟除
11、尘降温设施筛选切片粉碎压缩空气惰性气体取样称量室active vacci ne/in activatedblood productspreve nti onproductsfilli ngChin esetraditi onalpretreatme ntextractio nconcen trati onvacc inemedici nesviscera of animal, organ of animalcon coctedven tilatio nsmoke removaldust removaltemperature-reduc ingscree ningslici nggrinding
12、compressed airn oble gassampli ngweighi ng roomestablishme nt,cooli ng中药标本检定同位素设备选型耐腐蚀吸附润滑剂，润滑冷却剂流向纯化水注射用水滋生储罐死角盲管纤维疏水性仪表量具衡器Chinese herbal sample, exemplar of TCM鉴定verificati on,Isotopeequipme ntmodel/typean ticorrosi onadsorpti on,absorptio nlubrica nt, lubricatecoola ntflow direct ionPW: Purified
13、 WaterWFI: Water for Injectionbreed ingtankn eglectedporti onbli nd pipefiberhydrophobicityin strume ntati onmeasuri ng toolweigh ingin strume ntselect ionide ntificati on精密度维修、保养不合格物料购买发放产地固体液体挥发性净药材麻醉药品精神药品易燃易爆验收使用说明书标签卫生车间间隔时间precisi onmaintenancedisqualifiedmaterialpurchas ingreleas ingorigi nso
14、lidliquidvolatilenet medicine, net TCMn arcoticspsychotropic drugcombustibleexplosiveaccepta neein structi onlabelhygie neworkshoptime in terval清洁剂消毒剂废弃物更衣室工作服，颗粒性物质，颗粒剂耐药菌株传染病皮肤病验证确认安装运行性能原辅料文件投诉报废品名处方技术参数deterge ntdis in fecta ntwastescha ngingroomwork clothesgranu lesdrug-resista ntstrainin fecti
15、ousdiseasedermatosisverificati on, validati onqualificati onin stallati onrunning operati onperforma neeraw material and excipie ntdocume ntcomplai ntrejectproduct n ameprescripti on,formulatech ni cal parameter容器申请稳定性起草containerapplicati onstabilitydraftproducti onman ageme nt,manu facturi ngcont生产
16、管理rol.混淆喷雾合格证清场质里官理内控滴定液培养基有效期产品销售与收回投诉与不良反应报告自检附则平衡饮用水mix-upspraycertificatecleara neequality man ageme ntinternal con troltitra ntmediumvalidity, expiry date, shelf lifeproduct sales and recallcompla ints and adverse react ionself- in spect ionappe ndixbala needrinking waterreport蒸馏法离子交换法反渗透法附加剂添加
17、剂滞留批组分，组成无纤维脱落的过滤器活性成份非活性成份中间产品批号药用物料药用预混合料质量控制部门理论产量实际产量比率验收标准可接受标准代表性样品微粒状的distillatio nion exchangeRO: Reverse Osmosisadditivesstra ndedbatch, lotcomp onentnon-fiber-releas ingActive In gredie ntIn activein gredie ntproductfilterresortin termediatebatch nu mbermedicated feedmedicated premixQualit
18、ycon trolTheoretical yieldActual yieldPerce ntage, rateAccepta nee criteriaReprese ntative sampleparticulatedepartme nt污染物石棉诊断缓解化学变化组分制备复合混合加工浓度单位剂量药品包装容器密圭寸件，圭寸盖效价纯度规格监督实验室无菌操作层流con tam inantasbestosdiag no sismitigatio nchemicalcha ngein gredie nt,fabricatecompo undble ndprocess ingconcen trati on
19、unit dosedrug product containersclosuretiterpuritystre ngthsupervise,laboratoryasepticoperati on,sterile operatio nmon itorcomp onentpreparati onlam inar flow湍流空气过滤空气加热预过滤器排气系统管件污水废料空气干燥器垃圾有机废料杀鼠剂杀昆虫剂杀真菌剂熏烝剂去垢剂消毒剂滂沱剂自动化设备、机械化设备和电子设备微型胶卷turbule ntair filtrationair heatingPre-filterair flowexhaust sys
20、templumbi ngsewagerefuseair driertrashorga nicwasterode nticidesin secticidesfun gicidesfumigati ngreage ntsclea ning age ntssan itiz inglubrica ntautomatic, mechanical, or electronictmicrofilmequipmenage nts注射剂火菌设备无菌取样技术显微镜热源，内毒素偏差变更进料项目代码鉴别片剂胶囊颗粒剂溶解时间澄明度隔离系统返工发放非处方药处方药保险包装injectio nsterilizatio ne
21、quipme nttech niq uesaseptic sampli ngmicroscopepyroge n, en dotox indeviati oncha nge con trolcharge-i nitem codeidentifytabletcapsulegranuledissoluti ontimeclarityisolati onsystemreprocess ingissua nee, releaseOTC: over-the-counterprescripti onmedici nepackagetamper-resista nt明胶硬胶囊顺势治疗入库变质准确性灵敏性特异
22、性重复性变应原提取物眼膏粗糙或磨蚀物质控释制剂实验动物供应商光谱测量单位换算系数试剂安慰剂明确地取代hard gelatin capsulehomeopathicwarehous ingdeteriorateaccuracysen sitivityspecificityreproducibility,allerge nic extractsophthalmicoin tme ntrepeatabilityharsh or abrasive substancescon trolled-releaselaboratorysupplierspectrumunits of measurecon ver
23、s ion factorsreage ntplaceboexplicitlysupersedeani malsdosage form溶液批准（美国）食品药品监督管理局标准操作程序质量保证质里控制批生产记录批检验记录工艺规程健康，安全，环保美国联邦法规美国药典欧洲药典英国药典药物主文件验证主计划验证方案验证报告安装确认运行确认性能确认solutio napprovalFDA: Food and Drug AdministrationSOP: StandardQA: QualityQC: QualityOperating ProcedureAssuraneeControlRecordBPR: Ba
24、tch ProduetionBAR: Batch Analysis RecordPP:EHS:Process ProcedureEn viro nmen t,Health and SafeCFR: Code of Federal RegulationUSP: The United States PharmacopeiaEP: Europea npharmacopeiaBP: British pharmacopeiaDMF: Drug Master FileVMP: ValidationVP:VR:IQ:OQ:PQ:Master PlanValidatio n ProtocolValidati onReportIn stallati onQualificati onOperati on Qualificati onPerforma nee Qualificatio n超出标准（限度）冻干产品工厂主述文件OOS:Out of Specificationproduct, lyophilized productfreeze-drySMF: Site Master File感谢下载!欢迎您的下载，资料仅供参考
