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1、_生产工艺常用词汇：中文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安瓿瓶灭菌除热源英文英文Kanamycin sulfatesodium bisulfatesodium citrateSulfuric acid solutionNeutral borosilicate glass ampouleAmpoule washingAmpoulesterilizationanddepyrogenation配料过滤灌封灭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BatchingFiltrationFilling and sealingSterili
2、zation and leakage testVisual/Lamp inspectionLabeling and packagingCritical Process Parameterheating sectionconveyor beltDifferential pressureTime intervalPore 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Filtration pressureFilling volumebuffer tankpre-filling nitrogen flushpost-filling nitrogen
3、overlayVacuum leak testPrimary packaging materialProcess instructionLivzonGroupFuzhouFuxingPharmaceutical Co.Ltd.Hunan Erkang Pharmaceutical Co.,LtdHunan Huari Pharmaceutical Co.,LtdGuangzhou Chemical Reagent FactoryZhuhai Da Lin Wan Industrial Gas Co.,LtdSCHOTT Glass Technologies(Suzhou)Co.Ltdquali
4、ty specificationCirculation waterRotating speed_QC 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示量可见异物无菌薄膜过滤法内毒素英文Physical attributesAppearanceParticulate matterSolution colorIdentificationretention timeAssayRelated substancelabeled amountVisible particlesSterilityMembrane filtration methodBacterial endotoxi
5、nsInitial bioburdenstirring uniformityashy toppointed endbubble head,flat head,broken ampoule,crooked ampoule,empty ampoule;_中文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英文GMP:Good Manufacturing PracticeState Food and Drug AdministrationGeneral ProvisionspreparationAPI:Active Pharmace
6、utical Ingredientfinished goodsprocessorganization and personnelprofessional knowledgeproduction experienceorganizational skilltechnical staff_实施药品生产质量管理质量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高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implementationpharmaceutical manufacturingquality managementquality inspe
7、ctionprofessional and technical trainingbasic theoretical knowledgepractical operation skillshighly potenthigh toxicitycontaminationassessmentbuildings and facilitiesproduction environmentclean air levelinsectclean room(area)smoothno cracksno particle sheddingtolerancedisinfection_无菌交界处弧形灰尘积聚储存区生产规模
8、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 天花板sterilejunction,jointarcdust accumulationstore areaproduction scaleequipmentmaterialintermediate productquarantined materialcross-contaminationpipelineutilities of public servicelightingilluminationemergencypurification,cleanmicro-organism,mic
9、robiology,microbiologicmonitoringrecordceiling,roof_密封静压差温度相对湿度地漏分装室相对负压废气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sealStatic Differential PressuretemperatureRH:Relative Humidityfloor drainerseparating room,filling roomrelative negative pressurewaste gas,exhausted air-Lactams structure drugcontra
10、ceptiveshormoneanti-tumor,oncologyRadiopharmaceuticalspacking,packagerecyclingparticlesradiationbacteriaviruscellPre-detoxification and post detoxification_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 vaccine/inactivated vaccineblood productsprevention productsfillingChinese
11、 traditional medicinespretreatmentextractionconcentrationviscera of animal,organ of animalconcoctedventilationsmoke removaldust removaltemperature-reducing establishment,coolingscreeningslicinggrindingcompressed airnoble gassamplingweighing room_中药标本检定鉴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
12、具衡器Chinese herbal sample,exemplar of TCMverification,identificationIsotopeequipmentmodel/type selectionanticorrosionadsorption,absorptionlubricant,lubricatecoolantflow directionPW:Purified WaterWFI:Water for Injectionbreedingtankneglected portionblind pipefiberhydrophobicityinstrumentationmeasuring
13、toolweighing instrument_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precisionmaintenancedisqualifiedmaterialpurchasingreleasingoriginsolidliquidvolatilenet medicine,net TCMnarcoticspsychotropic drugcombustibleexplosiveacceptanceinstructionlabelhygieneworkshoptime interval_清洁剂消毒剂废弃物更衣室工
14、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detergentdisinfectantwasteschanging roomwork clothesgranulesdrug-resistant straininfectious diseasedermatosisverification,validationqualificationinstallationrunning operationperformanceraw material and excipientdocumentcomplaintrejectproduct namepresc
15、ription,formulatechnical parameter_容器申请稳定性起草containerapplicationstabilitydraftproduction management,manufacturing cont生产管理rol.mix-upspraycertificateclearancequality managementinternal controltitrantmediumvalidity,expiry date,shelf lifeproduct sales and recallcomplaints and adverse reaction reportsel
16、f-inspectionappendixbalancedrinking water混淆喷雾合格证清场质量管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_蒸馏法离子交换法反渗透法附加剂添加剂滞留批组分,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distillationion exchangeRO:Reverse Osmosisadditivesstranded resortbatch,lotcomponentnon-fiber-releasing filterActiv
17、e IngredientInactive ingredientintermediate productbatch numbermedicated feedmedicated premixQuality control departmentTheoretical yieldActual yieldPercentage,rateAcceptance criteriaRepresentative sampleparticulate_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封件,封盖效价纯度规格监督实验室无菌操作层流contaminantasbestosdiagnosi
18、smitigationchemical changeingredient,componentfabricate preparationcompoundblendprocessingconcentrationunit dosedrug product containersclosuretiterpuritystrengthsupervise,monitorlaboratoryaseptic operation,sterile operationlaminar 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蒸剂去垢剂消毒剂滂沱剂自动化设备、
19、机械化设备和电子设备微型胶卷turbulent air flowair filtrationair heatingPre-filterexhaust systemplumbingsewagerefuseair driertrashorganic wasterodenticidesinsecticidesfungicidesfumigating reagentscleaning agentssanitizing agentslubricantautomatic,mechanical,or electronic equipmentmicrofilm_注射剂灭菌设备无菌取样技术显微镜热源,内毒素偏差
20、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injectionsterilization equipmentaseptic sampling techniquesmicroscopepyrogen,endotoxindeviationchange controlcharge-initem codeidentifytabletcapsulegranuledissolution timeclarityisolation systemreprocessingissuance,releaseOTC:over-the-counterprescription me
21、dicinetamper-resistant package_明胶硬胶囊顺势治疗入库变质准确性灵敏性特异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 capsulehomeopathicwarehousingdeteriorateaccuracysensitivityspecificityreproducibility,repeatabilityallergenic extractsophthalmic ointmentharsh or abrasive substancescontrolled-release d
22、osage formlaboratory animalssupplierspectrumunits of measureconversion factorsreagentplaceboexplicitlysupersede_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量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solutionapprovalFDA:Food and Drug AdministrationSOP:Standard Operating ProcedureQA:Qual
23、ity AssuranceQC:Quality ControlBPR:Batch Production RecordBAR:Batch Analysis RecordPP:Process ProcedureEHS:Environment,Health and SafeCFR:Code of Federal RegulationUSP:The United States PharmacopeiaEP:European pharmacopeiaBP:British pharmacopeiaDMF:Drug Master FileVMP:Validation Master PlanVP:Validation ProtocolVR:Validation ReportIQ:Installation QualificationOQ:Operation QualificationPQ:Performance Qualification_超出标准(限度)冻干产品工厂主述文件OOS:Out of Specificationfreeze-dry product,lyophilized productSMF:Site Master File