发光免疫类检测试剂注册技术审查指导原则en

《发光免疫类检测试剂注册技术审查指导原则en》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。

1、Attachment2GuidelineforTechnicalReviewofRegistrationofLuminescentImmunoassayClassDetectionReagentsI.PrefaceThisGuidelineadvancesguidingtechnicalrequirementsonthemainrawmaterials,productionprocessesandreactionsystem,andproductqualitycontrolthatarcspecificallyforluminescent

2、immunoassayclassdetectionreagents.ThisGuidelineisageneralrequirementforluminescentimmunoassaydetectionreagents.TheApplicantshalldeterminewhetherthecontentisapplicableinaccordancewiththespecificpropertiesoftheproduct.Ifnotapplicable,theApplicantshallundergojustificationwit

3、hspecificexplanation,andthecorrespondingscientificbasisshallbeprovided.ThisGuidelineshallactasaguidancedocumentforapplicantsandpersonnelofexaminationauthority.However,thisGuidelineshallnotincludetheadministrativemattersinvolvedduringtheregistrationexaminationandapprovalan

4、dshallnotbeexecutedasamandatoryregulation.Shouldtherebeothermethodsmeetingtheappropriateregulatoryrequirements,thesemethodscanbeusedaswell.However,detailedresearchinformationandverificationdocumentationshallbeprovided.ThisGuidelineshallbeutilizedincompliancewiththerelevan

5、tlawsandregulationsunderthepremise.ThisGuidelineisdevelopedundertheexistingregulations,standards,andthecurrentlyacceptedknowledgebasis.Withthecontinuousimprovementoftheregulationsandstandardsandthecontinuousdevelopmentofscientifictechnology,therelevantcontentofthisGuideli

6、neshallundergotimelyadjustmentsaccordingly.ILScopeofApplicationThisguidelineismainlyapplicablefortechnicalreviewofregistrationofclassIIIinvitrodiagnosticreagentsutilizingluminescentimmunoassayanalysistechniquetoundergotestingonsubstances,namelyproteins.ThisGuidelinecanber

7、eferencedandexecutedforthemanufacturingandqualitycontrolofclassIIdetectionreagents.III.GeneralRequirement(I)GeneralPrinciple1.ApplicablequalitystandardsshallbeestablishedforvariousrawmaterialsandauxiliarymaterialsusedinR&Dandmanufacturingandshallconformtotherequirementsof

8、therelevantregulations.1.Manufacturingenterprisesofdiagnosticreagentsshallbeequippedwiththecorre