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Bioreactordesignforanimalcellcultures:cGMPaspectsAsupplierperpectiveContentcGMPinequipmentcGMPguidelinescGMPdesignrulescGMPinpracticecGMPindocumentationApplikonBiotechnologySpecialistsinelectronicandmechanicalengineeringProcessengineeringProjectengineeringandmanagementHygienicprocessingG(A)MPValidationDocumentationApplikonBiotechnologyApplikonBiotechnologycGMP

cURRENTGoodManufacturingPractice

inBioreactordesignInternationalstandardscGMPHAZOPISO9000DesigncodesCE/ASME/CSAInternationalpressurecodes:CE/ASME/CSA/JISASMEBPE2009MaterialsProceduresHygienicdesignWeldingSurfacefinishing

cGMPGMPregulationsaddressissuesincludingrecordkeeping,personnelqualifications,sanitation,cleanliness,equipmentverification,processvalidation,andcomplainthandlingFOROURDRUGPRODUCERScGMPguidelinesverygenericdescribedin21CFR210en21CFR211oftheFDA.GMPrequirementsareverygeneralandopen-ended,allowingeachmanufacturertodecideindividuallyhowtobestimplementthenecessarycontrols

cGMPGMPareguidelinesandnotclearspecificationsGMPdocumentsarenotdefinedExamplesareavailable,butmustbeadaptedtothespecificsituationUnderstandthebackgroundofcGMPDocumentonlywhatisusefulaccordingcGMPcGMPdocumentsarenotfreeofchargeWorkingaccordingGMPisneverfinished:itneedscontinuousimprovement

cGMPDeliberatevaguenessAllowsinnovativeideasbasedupon“GoodScience”tobeimplementedItallowstheIndustrytoleaditsowntechnologicaladvancesTheresponsibilityandimplementationofcGMPisleftuptoAuditedrecipientGMPswereestablishedbeforevalidationwascommonpractice

cGMPValidationEstablishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspre-determinedspecificationsandqualityattributes.

cGMP

IntegratewithValidationDocumentationasappropriateSUPPLIERFunctionalSpecification(traceabletoURS)

USER/(CONSULTANTifapplicable)

MasterValidationPlanRFQUserAuditProposal

ProjectPlan

Quality&ValidationPlanEquipmentValidationPlan

ExplanationtoSupplierUserRequirementsSpecification(LivingDocument)ProposalAnalysisProposalP.O.DetailedDesignDocumentation(traceabletoFunctionalSpecification)ReviewFunctionalSpecificationReviewDetailedDesignSystemAcceptanceTestSpecifications(IQ/OQ)

HardwareSoftware

ReviewSystemAcceptanceTestSpecifications

SystemAcceptanceTestingandResultsUserWitnessOptional

ApprovalApprovalApprovalEngineeringFeasibilityStudyandResultsP.O.GAMPGAMPGAMPURSSigningandHistoryOperationalrequirementsConstrainsLifecycleTestableGAMPPQPSigningandHistoryIdentification(personnel/equipment)DetailedinstructionsAcceptancecriter

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