证书申请递交的质量综述模板 QOSVIP免费

TemplateforQualityOverallSummarytobesubmittedforCertificationapplications证书申请递交的质量综述模板NB:Reference:PA/PH/CEP(04)1(asrevised)Contentofthedossierforchemicalpurityandmicrobiologicalquality(canbedownloadedfromEDQMwebsitehttp://www.edqm.eu)QUALITYOVERALLSUMMARY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(*):APPENDCVOFTHEEXPERTQUALITYOVERALLSUMMARY2.3.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)Solubilityandotherpropertiesasnecessary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)includingtheirjustificationbasedo...