精品生產工藝常用詞匯：中文英文單硫酸卡那霉素Kanamycinsulfate硫酸氫鈉sodiumbisulfate枸櫞酸鈉sodiumcitrate硫酸溶液Sulfuricacidsolution中性硼玻璃安瓿瓶Neutralborosilicateglassampoule安瓿瓶清洗Ampoulewashing安瓿瓶滅菌除熱源Ampoulesterilizationanddepyrogenation配料Batching過濾Filtration灌封Fillingandsealing滅菌和檢漏測試Sterilizationandleakagetest燈檢Visual/Lampinspection貼簽和包裝Labelingandpackaging關鍵工藝參數CriticalProcessParameter升溫段heatingsection傳送帶conveyorbelt壓差Differentialpressure時間間隔Timeinterval過濾器孔徑Poresizeoffilter感謝下載載精品過濾壓力Filtrationpressure灌裝量Fillingvolume緩沖罐buffertank灌裝前充氮保護pre-fillingnitrogenflush灌裝后充氮保護post-fillingnitrogenoverlay真空檢漏測試Vacuumleaktest內包材PrimarypackagingmaterialProcessinstructionLivzonGroupFuzhouFuxingPharmaceuticalCo.Ltd.HunanErkangPharmaceuticalCo.,LtdHunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactoryZhuhaiDaLinWanIndustrialGasCo.,LtdSCHOTTGlassTechnologies(Suzhou)Co.LtdqualityspecificationCirculationwaterRotatingspeed感謝下載載精品QC常用英文詞匯中文 英文物理性狀 Physicalattributes外觀 Appearance不溶性微粒 Particulatematter溶液顏色 Solutioncolor鑒別 Identification保留時間 retentiontime含量 Assay有關物質 Relatedsubstance標示量 labeledamount可見異物 Visibleparticles無菌 Sterility薄膜過濾法 Membranefiltrationmethod內毒素 BacterialendotoxinsInitialbioburdenstirringuniformityashytoppointedendbubblehead,flathead,brokenampoule,crookedampoule,emptyampoule;感謝下載載精品中文英文藥品生產質量管理規(guī)范GMP:GoodManufacturingPractice國家食品與藥品監(jiān)督管理局StateFoodandDrugAdministration總則GeneralProvisions制劑preparation原料藥API:ActivePharmaceuticalIngredient成品finishedgoods工序process機構與人員organizationandpersonnel專業(yè)知識professionalknowledge生產經驗productionexperience組織能力organizationalskill技術人員technicalstaff感謝下載載精品實施implementation藥品生產pharmaceuticalmanufacturing質量管理qualitymanagement質量檢驗qualityinspection專業(yè)技術培訓professionalandtechnicaltraining基礎理論知識basictheoreticalknowledge實際操作技能practicaloperationskills高生物活性highlypotent高毒性hightoxicity污染contamination考核評估assessment廠房與設施buildingsandfacilities生產環(huán)境productionenvironment空氣潔凈級別cleanairlevel昆蟲insect潔凈室（區(qū)）cleanroom(area)光滑smooth無裂縫nocracks無顆粒物脫落noparticleshedding耐受tolerance消毒disinfection感謝下載載精品無菌sterile交界處junction,joint弧形arc灰塵積聚dustaccumulation儲存區(qū)storearea生產規(guī)模productionscale設備equipment物料material中間產品intermediateproduct待驗品quarantinedmaterial交叉污染cross-contamination管道pipeline公用設施utilitiesofpublicservice照明lighting照度illumination應急,緊急情況emergency凈化purification,clean微生物,微生物學,微生物的micro-organism,microbiology,microbiologic監(jiān)測monitoring記錄record天棚天花板ceiling,roof感謝下載載精品密封seal靜壓差StaticDifferentialPressure溫度temperature相對濕度RH:RelativeHumidity地漏floordrainer分裝室separatingroom,fillingroom相對負壓relativenegativepressure廢氣wastegas,exhaustedairβ－內酰胺結構類藥品β-Lactamsstructuredrug避孕藥品contraceptives激素類hormone抗腫瘤類anti-tumor,oncology放射性藥品Radiopharmaceuticals包裝packing,package循環(huán)使用recycling微粒particles輻射radiation細菌bacteria病毒virus細胞cell脫毒前后Pre-detoxificationandpostdetoxification感謝下載載精品活疫苗與滅活疫苗activevaccine/inactivatedvaccine人血液制品bloodproducts預防制品preventionproducts灌裝filling中藥Chinesetraditionalmedicines前處理pretreatment提取extraction濃縮concentration動物臟器visceraofanimal,organofanimal炮制concocted通風ventilation除煙smokeremoval除塵dustremoval降溫設施temperature-reducingestablishment,cooling篩選screening切片slicing粉碎grinding壓縮空氣compressedair惰性氣體noblegas取樣sampling稱量室weighingroom感謝下載載精品中藥標本Chineseherbalsample,exemplarofTCM檢定鑒定verification,identification同位素Isotope設備equipment選型model/typeselection耐腐蝕anticorrosion吸附adsorption,absorption潤滑劑,潤滑lubricant,lubricate冷卻劑coolant流向flowdirection純化水PW:PurifiedWater注射用水WFI:WaterforInjection滋生breeding儲罐tank死角neglectedportion盲管blindpipe纖維fiber疏水性hydrophobicity儀表instrumentation量具measuringtool衡器weighinginstrument感謝下載載精品精密度precision維修、保養(yǎng)maintenance不合格disqualified物料material購買purchasing發(fā)放releasing產地origin固體solid液體liquid揮發(fā)性volatile凈藥材netmedicine,netTCM麻醉藥品narcotics精神藥品psychotropicdrug易燃combustible易爆explosive驗收acceptance使用說明書instruction標簽label衛(wèi)生hygiene車間workshop間隔時間timeinterval感謝下載載精品清潔劑detergent消毒劑disinfectant廢棄物wastes更衣室changingroom工作服,workclothes顆粒性物質,顆粒劑granules耐藥菌株drug-resistantstrain傳染病infectiousdisease皮膚病dermatosis驗證verification,validation確認qualification安裝installation運行runningoperation性能performance原輔料rawmaterialandexcipient文件document投訴complaint報廢reject品名productname處方prescription,formula技術參數technicalparameter感謝下載載精品容器container申請application穩(wěn)定性stability起草draftproductionmanagement,manufacturingcont生產管理rol.混淆mix-up噴霧spray合格證certificate清場clearance質量管理qualitymanagement內控internalcontrol滴定液titrant培養(yǎng)基medium有效期validity,expirydate,shelflife產品銷售與收回productsalesandrecall投訴與不良反應報告complaintsandadversereactionreport自檢self-inspection附則appendix平衡balance飲用水drinkingwater感謝下載載精品蒸餾法distillation離子交換法ionexchange反滲透法RO:ReverseOsmosis附加劑添加劑additives滯留strandedresort批batch,lot組分,組成component無纖維脫落的過濾器non-fiber-releasingfilter活性成份ActiveIngredient非活性成份Inactiveingredient中間產品intermediateproduct批號batchnumber藥用物料medicatedfeed藥用預混合料medicatedpremix質量控制部門Qualitycontroldepartment理論產量Theoreticalyield實際產量Actualyield比率Percentage,rate驗收標準可接受標準Acceptancecriteria代表性樣品Representativesample微粒狀的particulate感謝下載載精品污染物contaminant石棉asbestos診斷diagnosis緩解mitigation化學變化chemicalchange組分ingredient,component制備fabricatepreparation復合compound混合blend加工processing濃度concentration單位劑量unitdose藥品包裝容器drugproductcontainers密封件,封蓋closure效價titer純度purity規(guī)格strength監(jiān)督supervise,monitor實驗室laboratory無菌操作asepticoperation,sterileoperation層流laminarflow感謝下載載精品湍流turbulentairflow空氣過濾airfiltration空氣加熱airheating預過濾器Pre-filter排氣系統(tǒng)exhaustsystem管件plumbing污水sewage廢料refuse空氣干燥器airdrier垃圾trash有機廢料organicwaste殺鼠劑rodenticides殺昆蟲劑insecticides殺真菌劑fungicides熏蒸劑fumigatingreagents去垢劑cleaningagents消毒劑sanitizingagents滂沱劑lubricant自動化設備、機械化設備和電子設automatic,mechanical,orelectronicequipmen備t微型膠卷microfilm感謝下載載精品注射劑injection滅菌設備sterilizationequipment無菌取樣技術asepticsamplingtechniques顯微鏡microscope熱源,內毒素pyrogen,endotoxin偏差deviation變更changecontrol進料charge-in項目代碼itemcode鑒別identify片劑tablet膠囊capsule顆粒劑granule溶解時間dissolutiontime澄明度clarity隔離系統(tǒng)isolationsystem返工reprocessing發(fā)放issuance,release非處方藥OTC:over-the-counter處方藥prescriptionmedicine保險包裝tamper-resistantpackage感謝下載載精品明膠硬膠囊hardgelatincapsule順勢治療homeopathic入庫warehousing變質deteriorate準確性accuracy靈敏性sensitivity特異性specificity重復性reproducibility,repeatability變應原提取物allergenicextracts眼膏ophthalmicointment粗糙或磨蝕物質harshorabrasivesubstances控釋制劑controlled-releasedosageform實驗動物laboratoryanimals供應商supplier光譜spectrum測量單位unitsofmeasure換算系數conversionfactors試劑reagent安慰劑placebo明確地explicitly取代supersede感謝下載載精品溶液solution批準ap