发光免疫类检测试剂注册技术审查指导原则 EN.docx
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发光免疫类检测试剂注册技术审查指导原则EN
Attachment2
GuidelineforTechnicalReviewofRegistrationofLuminescentImmunoassayClassDetectionReagents
I.Preface
ThisGuidelineadvancesguidingtechnicalrequirementsonthemainrawmaterials,productionprocessesandreactionsystem,andproductqualitycontrolthatarespecificallyforluminescentimmunoassayclassdetectionreagents.
ThisGuidelineisageneralrequirementforluminescentimmunoassaydetectionreagents.TheApplicantshalldeterminewhetherthecontentisapplicableinaccordancewiththespecificpropertiesoftheproduct.Ifnotapplicable,theApplicantshallundergojustificationwithspecificexplanation,andthecorrespondingscientificbasisshallbeprovided.
ThisGuidelineshallactasaguidancedocumentforapplicantsandpersonnelofexaminationauthority.However,thisGuidelineshallnotincludetheadministrativemattersinvolvedduringtheregistrationexaminationandapprovalandshallnotbeexecutedasamandatoryregulation.Shouldtherebeothermethodsmeetingtheappropriateregulatoryrequirements,thesemethodscanbeusedaswell.However,detailedresearchinformationandverificationdocumentationshallbeprovided.ThisGuidelineshallbeutilizedincompliancewiththerelevantlawsandregulationsunderthepremise.
ThisGuidelineisdevelopedundertheexistingregulations,standards,andthecurrentlyacceptedknowledgebasis.Withthecontinuousimprovementoftheregulationsandstandardsandthecontinuousdevelopmentofscientifictechnology,therelevantcontentofthisGuidelineshallundergotimelyadjustmentsaccordingly.
II.ScopeofApplication
ThisguidelineismainlyapplicablefortechnicalreviewofregistrationofclassIIIinvitrodiagnosticreagentsutilizingluminescentimmunoassayanalysistechniquetoundergotestingonsubstances,namelyproteins.ThisGuidelinecanbereferencedandexecutedforthemanufacturingandqualitycontrolofclassIIdetectionreagents.
III.GeneralRequirement
(I)GeneralPrinciple
1.ApplicablequalitystandardsshallbeestablishedforvariousrawmaterialsandauxiliarymaterialsusedinR&Dandmanufacturingandshallconformtotherequirementsoftherelevantregulations.
2.Manufacturingenterprisesofdiagnosticreagentsshallbeequippedwiththecorrespondingprofessionaltechnicalpersonnel,instrumentsandequipment,andappropriatemanufacturingenvironmentwithobtainmentof“MedicalDeviceManufacturingLicense”.Moreover,themanufacturingenterprisesshallestablishthecorrespondingqualitymanagementsysteminaccordancewiththerequirementsstatedinthe“DetailedRulesforImplementationofManufacturingofinvitroDiagnosticReagents(Interim)”withformationofwrittendocumentsandrecordstoimplementandmaintaineffectiveoperation.Additionally,themanufacturingenterprisesshallpasstheexaminationofthe“ExaminationandEvaluationStandardsforQualityManagementSystemofManufacturingEnterprisesofinvitroDiagnosticReagents(Interim)”.Theenterprisesshallclearlystatetherangeofapplicabilityofthedetectionreagentsandshallbeapprovedbythestatedrugregulatorydepartment.
3.R&Dofdiagnosticreagentsshallbecarriedoutinaccordancewithscientificandpracticalprinciples.Generalscientificprinciplesshallbecompliedforselectionanddeterminationofvariousreactionconditions.
4.ThematerialsandtechnicalprocessesusedintheR&Dandmanufacturingprocessshallfullyconsiderallmatterspertainingtothesafetyaspectthatmaybeinvolved.
5.Theoveralltargetofmanufacturingandqualitycontrolofthedetectionreagents:
assuringthesafeuseoftheproductwithstablequality,controllabletechnicalprocess,andeffectiveuse.
(II)QualityControlofRawMaterials
1.Majorbiologicalrawmaterials
Thebiologicalrawmaterialsthataremostlycloselyrelatedtothequalityoftheproductmainlyincludevariousnaturalantigens,recombinantantigens,monoclonalantibodies,polyclonalantibodies,polypeptides,andhormones.Thisclassofrawmaterialsmaybeusedforcoatingmicro-aperturereactionplate,labelingrelevantenzymes(horseradishperoxidaseandalkalinephosphatase),neutralizingreactionusedantigenorantibody,andpreparingcalibrators(standardcontrols).Qualityinspectioniscarriedoutonthisclassofbiologicalrawmaterialsaccordingtotherequirementsofthetechnicalprocessgenerallytoassurethattheyhaveattainedthespecifiedqualitystandards.Thetechnicalprocessmustberelativelystableifthemainbiologicalrawmaterialsareself-manufacturedbytheenterprises.Iftheyareoutsourced,thesuppliersmustbefixedwithoutanychangesofsuppliersatwill.Intheeventthatthemainrawmaterials(includingtechnicalprocess)ortheirsuppliersarechanged,applicationforchangemustbesubmittedinaccordancewiththerequirementsofther