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《生物反應(yīng)器課件 Bioreactor design for animal cell cultures： cGMP aspects》由會(huì)員上傳分享，免費(fèi)在線閱讀，更多相關(guān)內(nèi)容在教育資源-天天文庫。
1、Bioreactordesignforanimalcellcultures:cGMPaspectsAsupplierperpectiveContentcGMPinequipmentcGMPguidelinescGMPdesignrulescGMPinpracticecGMPindocumentationApplikonBiotechnologySpecialistsinelectronicandmechanicalengineeringProcessengineeringProjectengineeringandmanagementHygienicprocessingG(A)MPVa
2、lidationDocumentationApplikonBiotechnologyApplikonBiotechnologycGMPcURRENTGoodManufacturingPracticeinBioreactordesignInternationalstandardscGMPHAZOPISO9000DesigncodesCE/ASME/CSAInternationalpressurecodes:CE/ASME/CSA/JISASMEBPE2009MaterialsProceduresHygienicdesignWeldingSurfacefinishingcGMPGMPre
3、gulationsaddressissuesincludingrecordkeeping,personnelqualifications,sanitation,cleanliness,equipmentverification,processvalidation,andcomplainthandlingFOROURDRUGPRODUCERScGMPguidelinesverygenericdescribedin21CFR210en21CFR211oftheFDA.GMPrequirementsareverygeneralandopen-ended,allowingeachmanufa
4、cturertodecideindividuallyhowtobestimplementthenecessarycontrolscGMPGMPareguidelinesandnotclearspecificationsGMPdocumentsarenotdefinedExamplesareavailable,butmustbeadaptedtothespecificsituationUnderstandthebackgroundofcGMPDocumentonlywhatisusefulaccordingcGMPcGMPdocumentsarenotfreeofchargeWorki
5、ngaccordingGMPisneverfinished:itneedscontinuousimprovementcGMPDeliberatevaguenessAllowsinnovativeideasbasedupon“GoodScience”tobeimplementedItallowstheIndustrytoleaditsowntechnologicaladvancesTheresponsibilityandimplementationofcGMPisleftuptoAuditedrecipientGMPswereestablishedbeforevalidationwas
6、commonpracticecGMPValidationEstablishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspre-determinedspecificationsandqualityattributes.cGMPIntegratewithValidationDocumentationasappropriateSUPPLIERFunctionalSpecification(traceab
7、letoURS)USER/(CONSULTANTifapplicable)MasterValidationPlanRFQUserAuditProposalProjectPlanQuality&ValidationPlanEquipmentValidationPlanExplanationtoSupplierUserRequirementsSpecification(LivingDocument)ProposalAnalysisProposalP.O.Det
