資源描述:
《發(fā)光免疫類(lèi)檢測(cè)試劑注冊(cè)技術(shù)審查指導(dǎo)原則EN.doc》由會(huì)員上傳分享,免費(fèi)在線(xiàn)閱讀,更多相關(guān)內(nèi)容在工程資料-天天文庫(kù)。
1、Attachment2GuidelineforTechnicalReviewofRegistrationofLuminescentImmunoassayClassDetectionReagentsI.PrefaceThisGuidelineadvancesguidingtechnicalrequirementsonthemainrawmaterials,productionprocessesandreactionsystem,andproductqualitycontrolthatarcspeci
2、ficallyforluminescentimmunoassayclassdetectionreagents.ThisGuidelineisageneralrequirementforluminescentimmunoassaydetectionreagents.TheApplicantshalldeterminewhetherthecontentisapplicableinaccordancewiththespecificpropertiesoftheproduct.Ifnotapplicabl
3、e,theApplicantshallundergojustificationwithspecificexplanation,andthecorrespondingscientificbasisshallbeprovided.ThisGuidelineshallactasaguidancedocumentforapplicantsandpersonnelofexaminationauthority.However,thisGuidelineshallnotincludetheadministrat
4、ivemattersinvolvedduringtheregistrationexaminationandapprovalandshallnotbeexecutedasamandatoryregulation.Shouldtherebeothermethodsmeetingtheappropriateregulatoryrequirements,thesemethodscanbeusedaswell.However,detailedresearchinformationandverificatio
5、ndocumentationshallbeprovided.ThisGuidelineshallbeutilizedincompliancewiththerelevantlawsandregulationsunderthepremise.ThisGuidelineisdevelopedundertheexistingregulations,standards,andthecurrentlyacceptedknowledgebasis.Withthecontinuousimprovementofth
6、eregulationsandstandardsandthecontinuousdevelopmentofscientifictechnology,therelevantcontentofthisGuidelineshallundergotimelyadjustmentsaccordingly.ILScopeofApplicationThisguidelineismainlyapplicablefortechnicalreviewofregistrationofclassIIIinvitrodia
7、gnosticreagentsutilizingluminescentimmunoassayanalysistechniquetoundergotestingonsubstances,namelyproteins.ThisGuidelinecanbereferencedandexecutedforthemanufacturingandqualitycontrolofclassIIdetectionreagents.III.GeneralRequirement(I)GeneralPrinciple1
8、.ApplicablequalitystandardsshallbeestablishedforvariousrawmaterialsandauxiliarymaterialsusedinR&Dandmanufacturingandshallconformtotherequirementsoftherelevantregulations.2.Manufacturingenterprisesofdiagnosticreagentsshallbeequippedwiththecorre