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ICEP/29TemplateforQualityOverallSummarytobesubmittedforCertificationapplications证书申请递交的质量综述模板NB:Reference:PA/PH/CEP(04)1(asrevised)Contentofthedossierforchemicalpurityandmicrobiologicalquality(canbedownloadedfromEDQMwebsite)ICEP/29QUALITYOVERALLSUMMARY质量综述Substancename产品名称Monographn°个论号Subtitle(ifany)副标题（如果有的话）IntendedHolderoftheCEPCEP证书持有人Writtenby撰写人Qualification*资质Date日期(*):APPENDCVOFTHEEXPERTICEP/29QUALITYOVERALLSUMMARY2.3.SDRUGSUBSTANCE原料药2.3.S.1GeneralInformation一般信息Useofthesubstance:Route(s)ofadministration,maximumdailydose.用途：（给药途径，每日最大剂量）Commercialisationhistory:Summarisethehistorybasedonthetableinapplicationform).贸易历史：（按申请表中的概述）Declarations:Summarisethedeclarationsappendedtotheapplicationform:声明：（概述附于申请表后的声明）-ManufactureofthesubstanceinaccordancewithICHQ7AGMPrules该原料药生产遵循了ICHQ7AGMP法规条款-Commitmentbythemanufacturertokeeptheproposedholderinformedofanychangestothedocumentation.生产商的承诺：任何文件变更都会及时通知持有人-ifapplicable:Manufacturer'sauthorisationforXtoactasrepresentative生产商对某人作为代表人的授权书（如果有的话）-Willingnesstobeinspected(holder,manufacturers)愿意接受现场检查（持有人，生产商）-Non-use/useofmaterialsofhumanoranimaloriginintheprocess生产过程中未使用/使用了来源于人或动物的物料2.3.S.1.1Nomenclature命名(a)RecommendedInternationalNon-proprietaryname(INN):国际非专有名称(b)Chemicalname(s):化学名(c)Companyorlaboratorycode:公司或实验室编码(d)Othernon-proprietaryname(s)(e.g.,nationalname,USAN,BAN):其他非专利名称（如，国家命名，美国采用名，英国认可名）(e)CASNo.MolecularFormula分子式MW:分子量2.3.S.1.3GeneralProperties特性Givesummariseddataon:提供以下信息(a)Physicaldescription(e.g.,appearance,colour,physicalstate…)形状描述（如：外观、颜色、物理状态）(b)Physicalform(e.g.,polymorphicform,solvate,hydrate):tobecommentedespeciallyifrequestedasgrade.物理形态（如：多晶型，溶剂化物，水合物）：按要求分级别作出描述(c)SolubilityandotherpropertiesasnecessaryICEP/29溶解性，及其他相关特性(d)Particlesize:e.g.«non-micronised»,«micronised»oranygradeclaimedassubtitle.粒度（如：非微粒、微粒，或其他级别说明，作为小标题）2.3.S.2Manufacture生产2.3.S.2.1Manufacturer(s)(name,manufacturer)andsitesinvolvedintheentireprocess生产商（产品名，公司名），及整个生产过程中涉及的场所Givethename,addressandresponsibilityofeachmanufacturer,includingcontractorsandmanufacturerandeachproposedproductionsiteorfacilityinvolvedinmanufacture.提供每个生产商的名称、地址、责任，包括承包商和生产商，以及生产过程涉及的每个拟定生产地点或设备2.3.S.2.2DescriptionofManufacturingProcessandProcessControls生产工艺和工艺控制的描述(a)Giveabriefnarrativestep-by-stepdescriptionofthemanufacturingprocess(es)andprovidereferencetodetaileddescriptioninthedocumentation.Confirmthemaximumbatchsize简要工艺描述，提供记录中详细描述作为参考。证实最大批量。(b)Ifapplicablesummarisealternateprocessesandgiveashortexplanationoftheiruse:如果有的话，概述变更工艺，并简短说明原因(c)Commentshortlyonrecoveryofmaterials(solvents,reagents,andmotherliquor)togetherwithreprocessingstepsandgiveabriefjustification:简单说明物料回收（溶剂、试剂和母液）和再回收步骤，并提供主要理由2.3.S.2.3ControlofMaterials物料控制I)Startingmaterial(s)起始物料(a)Givesummarisedspecifications(includingimpuritiesprofile)includingtheirjustificationbasedonstudiesofcarry-over.提供质量标准（包括杂质概况），并给出残留物研究的合理证明NB:Ifstartingmaterialisobtainedbyfermentationorisfromherbalorigin,summarisetheinformationrelatedtothenatureofthismaterial.注：如果起始物质为从发酵或植物提取中获得，概述这种物料性质的相关信息。II)Reagentsandsolvents试剂和溶剂Summarisethequalityandcontrolsofthematerials(e.g.,rawmaterials,ICEP/29solventspureand/orrecovered,reagents,catalysts)usedinthemanufactureofthedrugsubstance.概述原料药生产中用到的物料质量和控制信息（如：原材料，纯溶剂或回收溶剂，试剂，催化剂）2.3.S.2.4ControlsofCriticalStepsandIntermediates关键步骤和中间体的控制Summaryofthecontrolsperformedatcriticalstepsofthemanufacturingprocessandonintermediates,compareanalyticalproceduresusedforintermediatesandfinalsubstance.概述生产工艺以及对于中间体的关键步骤的控制信息，以及对中间体和最终产品的比较分析方法2.3.S.2.5ProcessValidationand/orEvaluation工艺验证和/或评估Forasepticprocessingandsterilizationonlygivethesummaryofprocessvalidationand/orevaluationstudies.对无菌操作和灭菌的工艺验证和/或评估提供概述2.3.S.3Characterisation特性2.3.S.3.2Impurities杂质(I)Relatedsubstances有关物质(a)Fillinthefollowingtableidentifyingrelatedsubstances,theiroriginanddistinguishingbetweenpotentialandactualimpuritiesandcomparingwithimpuritysectionofthemonograph:将有关物质填入下表，包括来源，潜在的和实际存在的杂质区别，以及药典中对应的杂质章节Chemicalname化学名称PhEurimpurityEP杂质Applicant’sspecifications申请规格PhEurspecificationsEP标准Origin来源Levelsfound级别LODofthemethod检测限LOQofthemethod定量限(b)Justifythesespecificationsbasedondataobservedforimpuritiesinrelevantbatches证明这些标准建立于典型批次的杂质研究资料之上(c)Discussbrieflyaboutthesuitabilityofthemonographtocontrolthepotentialimpuritiespresentinthesubstance(residualstartingmaterials,reactantsandreagentsetc.)ICEP/29简要讨论药典对于原料药中存在的潜在杂质控制的适应性（残留起始物质、反应物和试剂等）(d)specificdiscussiononpossiblegenotoxicimpurities:对于可能存在的具有基因毒性杂质的特别说明Giveabriefdiscussiononimpuritieswithpotentialgenotoxicitybasedontherequirementsoftheguideline(EMEA/CHMP/QWP/251344/2006).应指导方针(EMEA/CHMP/QWP/251344/2006)要求，对有潜在基因毒性的杂质进行简单讨论。II.Residualsolvent(s)/reagent(s)/catalyst(s)残留溶剂/试剂/催化剂(a)Fillinthefollowingtable填写下表Solvent/reagent/catalyst溶剂/试剂/催化剂Usedinstepx/yApplicant’slimit申请限度ICHclass/limitICH限度Levels(ppm)级别LODofthemethodLOQofthemethod(b)Discussbrieflythebasisforsettingthespecification:简要说明设定标准的依据2.3.S.4ControloftheDrugSubstance原料药控制2.3.S.4.1Specification规格Giveatablesu