原料药主档案(DMF)技术资料查检表

原料藥主檔案(DMF)技術資料查檢表編號No.項目Items說明Note資料頁碼Page一I.封面Coverpage送審資料封面應繕寫：申請公司名、原料藥主檔案(DMF)資料、藥品名稱(含中英文)、送審日期、若委託製造應註明製造廠名。Thefollowingshouldbeincluded:Nameandaddressofcorporateheadquartersandthemanufacturer,identificationofsubmission:DMFTechnicalDocumentforActivePrincipleIngredient,nameofsubjectAPI,dateofsubmission,andnameoforiginalequipmentmanufacturer,ifany.二II.目錄Tableofcontents三III.縮寫對照表Abbreviation四IV.摘要Abstract1.主成分Activesubstance化學結構(包括立體結構)Chemicalstructureincludingstereochemistry若化合物具光學活性者須明確標示其立體結構Identifyingchiralcenters,cis-transisomerism,etc化學名Chemicalname學名、原廠名、別名、CAS編碼、廠內代碼等Genericname,proprietaryname,chemicalname,codenumber,andChemicalAbstractsService(CAS)number,ifavailable分子式Molecularformula分子量Molecularweight外觀性狀Description外觀、顏色及物理化學性質等Appearance,color,physico-chemicalproperties,etc.2原料藥簡介BriefdescriptionofsubjectAPI3藥理作用機轉及臨床用途Mechanismsofpharmacologicalactionandclinicaluses4製造方法依據Referencedmethodssupportingthemanufacture(1)專利、文獻來源。(2)全文參考文獻影本列為本表第十四項資料併送。Patentsandliteraturereferences.PhotocopiesoffulltextattachedforItemXIV五V.製造說明Descriptionofmanufacturingprocesses1原料及試劑名稱Namesofstartingmaterials,solvents,reagents,auxiliarymaterialsandotheringredients2B.反應方程式Syntheticormanufacturingroute反應方程式需涵蓋反應條件、實際下料量、莫耳數及產率(含計算式)等。Includeschemicalstructuresofreactants(i.e.,startingmaterialsandintermediates,andalsomoleculesincorporatedintothestructure)andproducts,stereochemicalconfigurations,whereapplicable,intermediates(eitherinsituorisolated),andsolvents,catalysts,reagents,withwrittenstatementofreactionconditions(temperature,pH,time,pressure,etc.),actualquantity(weightandmoles)used,andyields(crudeand/orpurified;weightandpercent,shownbycalculation)3製造流程圖Diagrammaticflowchartofmanufacturingprocess六VI.原料藥之檢驗規格及成績書AnalyticalspecificationsandcertificateofanalysisofthesubjectAPI原料藥規格之依據：藥典收載之規格不得任意刪減，且應註明其版次。SpecificationsforthepharmacopeiaAPIshouldspecifytheeditionoftheofficialcompendiumandnotbechangedbyhaphazard.七VII.安定性試驗結果Stability(summaryandconclusion)至少6個月(依安定性試驗基準含加速試驗及長期試驗)Atleastsix-monthdataincludingacceleratedandlong-termtests八VIII.製造工廠名稱、地址、位置Manufacturingsite,name,andoperationallayout九IX.工廠相關單位及人員Unitsandpersonnelinvolved其中技術人員以實際參與此一原料相關製程及品管人員為主。資料內容應包括人名、職稱、所屬部門、參與工作之性質、相關學經歷、員工簽名對照表等。Onlytechnicalpersonnelinvolvedinthemanufactureandqualitycontroltobelisted.Thelistshouldcontainname,title,affiliatedunit,jobdescription,educationalbackgroundandexperiences,andtypewrittennameandsignature.十X.製造場所、設備規格與配置圖Manufacturingsite,equipmentcapabilities,andoperationallayout列出本產品製程相關設備之清單及配置圖(包含儀器廠牌、型號、代號)Providesalistofrelevantfacilitiesandequipments,andtheirlayout,includingtheirmanufacturers,makes,andmodels.十一XI.批次製造紀錄Recordofbatchmanufacture*若無法提供批次製造紀錄，可以「製程確效計畫書及報告書」替代。ProcessValidationProtocolandRecordcanbeasubstituteforthisitem.1製造日期Dateofmanufacture2批次生產量Quantityofbatchproduction3實際下料量Actualamountofmaterialsused含原料使用項目、下料量和管制紀錄Includesnameandamountofmaterialused,andrecordsofcontrol4批次紀錄結果討論Resultsanddiscussionofbatchrecord與所訂規格有偏差之結果應予說明，並提供其預防校正措施。Outofspecificationsshouldbeaddressedanddescriptionofthecorrectiveactionsandpreventiveactionstobeprovided.5使用溶劑、溶劑回收設備及回收率Solventsusedandfacilitiesfortheirrecycleandrecovery包括溶劑使用之濃度及數量、回收之數量、是否再利用及處理方式Includestheconcentrationsandamountofsolventsused,amountofrecycledsolvent,weatherre-used,anddisposalapproaches.6廢棄物之處理及設備Wastedisposalanditsfacilities委託處理時應檢附委託廠之證照及合約書影本等相關資料Inthecaseofcontractproposal,copiesoflicensesofthecontractorganizationandthecontractshouldbeprovided.7包裝容器之性質規格及檢驗方法SpecificationsandanalyticalmethodsfortheContainers十二XII.原料、中間體之檢驗規格、方法、紀錄、成績書及原料藥之檢驗方法與記錄Specifications,analyticalmethodsandrecord,certificatesofanalysisofstartingmaterialsandintermediates.AnalyticalmethodsandrecordoftheAPI.含檢驗設備、檢驗方法與檢驗紀錄、成績書Includesanalyticalinstruments,methods,records,andcertificatesofanalysis.1標準品之分析報告Analyticalreportsofthestandards包括來源、檢驗規格、方法及成績書Includessources,analyticalspecifications,methods,andcertificatesofanalysis2本案有關實驗室儀器設備清單Listofinstrumentsandfacilitiesused包含廠牌、型號、代號Majorequipments(describedintermsofcapabilities,application,andlocation),theirmakeandmodel.3起始原料Startingmaterials含來源、檢驗依據、規格、方法、紀錄及成績書Source,acceptancespecifications,tests(methodsshouldbebrieflydescribed)definingidentity,quality,andpurity,andcertificateofanalysis.4中間體（含關鍵中間體及最終中間體）Intermediates(includingkeyintermediatesandfinalintermediates)含檢驗依據、規格、方法、紀錄及成績書Includesspecifications,referencedanalyticalmethods,analyticalmethodsemployed,andcertificatesofanalysis.5原料藥之檢驗方法、結果及原始紀錄(包括成品不純物資料)Analyticalmethods,results,andoriginalrecordsoftheAPI(includingtheimpurityprofileoftheproduct)*若無法提供成品檢驗方法及結果之「原始紀錄」，可以「分析方法確效計畫書及報告書」替代。AnalyticalmethodsValidationProtocolandRecordcanbeasubstituteforthisitem.(1)含標準品及成品實測圖譜、化學結構鑑定、熔點及標準品出處，實測圖譜應載明品名、批號、試驗條件、檢測日期及操作者簽名，化學結構鑑定應包含儀器分析資料例如：紫外光譜(UV)、紅外光譜(IR)、質譜(MS)、核磁共振譜(NMR)、元素分析(Elementalanalysis)等。(2)含實際稱量結果及配製紀錄，有效數字之選取應統一且有意義，檢驗結果有數據者應填寫其數據，避免以合格、符合、陰性反應等字眼帶過。(3)成品不純物資料須含名稱、含量及處理方式，必要時須提供不純物之結構、檢驗方法及數據和圖譜。(1)SpectraoftheAPI,withthoseofthestandardsforcompar