生物反应器课件 Bioreactor design for animal cell cultures： cGMP aspects

《生物反应器课件 Bioreactor design for animal cell cultures： cGMP aspects》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

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