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

1、Bioreactor design for animal cell cultures:cGMP aspectsA supplier perpectiveContent cGMP in equipment cGMP guidelines cGMP design rules cGMP in practice cGMP in documentationApplikon Biotechnology Specialists in electronic and mechanical engineering Process engineering Project engineering and manage

2、ment Hygienic processing G(A)MP Validation DocumentationApplikon BiotechnologyApplikon BiotechnologycGMPcURRENT Good Manufacturing Practice in Bioreactor designInternational standards cGMP HAZOP ISO 9000 Design codes CE/ASME/CSA International pressure codes:CE/ASME/CSA/JISASME BPE 2009 Materials Pro

3、cedures Hygienic design Welding Surface finishingcGMP GMP regulations address issues including recordkeeping,personnel qualifications,sanitation,cleanliness,equipment verification,process validation,and complaint handling FOR OUR DRUG PRODUCERS cGMP guidelines very generic described in 21 CFR 210 en

4、 21 CFR 211 of the FDA.GMP requirements are very general and open-ended,allowing each manufacturer to decide individually how to best implement the necessary controlscGMP GMP are guidelines and not clear specifications GMP documents are not defined Examples are available,but must be adapted to the s

5、pecific situation Understand the background of cGMP Document only what is useful according cGMP cGMP documents are not free of charge Working according GMP is never finished:it needs continuous improvementcGMP Deliberate vagueness Allows innovative ideas based upon“Good Science”to be implemented It

6、allows the Industry to lead its own technological advances The responsibility and implementation of cGMP is left up to Audited recipient GMPs were established before validation was common practicecGMP Validation Establishing documented evidence which provides a high degree of assurance that a specif

7、ic process will consistently produce a product meeting its pre-determined specifications and quality attributes.cGMP Integrate with ValidationDocumentation as appropriateSUPPLIERFunctional Specification(traceable to URS)USER/(CONSULTANT if applicable)Master Validation PlanRFQUser AuditProposal Proje

8、ct Plan Quality&Validation PlanEquipment Validation Plan Explanation to SupplierUser RequirementsSpecification(Living Document)Proposal AnalysisProposalP.O.Detailed DesignDocumentation(traceable to Functional Specification)Review Functional SpecificationReview Detailed DesignSystem Acceptance TestSp

9、ecifications(IQ/OQ)Hardware Software Review SystemAcceptance Test Specifications System AcceptanceTesting and ResultsUser Witness Optional ApprovalApprovalApprovalEngineering Feasibility Study and ResultsP.O.GAMP15 MQ Customer ValidatedRequirements System1 User Requirement Specifications(URS)validat

10、ion 14 PQ questionnaire2 QuotationFunctional Specifications 13 SAT12 FAT3 Orderverification 11 OQ4 Design verification10 IQ specifications5 Hazardous operations 9 Productionreport(Hazop)6 Detail design verification8 DQspecifications 7 EngineeringGAMPCustomerCustomerEnd UserEnd UserDistributorDistrib

11、utorPRODUCTApplikon BiotechnologyPRIMARY PROCESSExternalDesignRealisationDP04:Start upAfter SalesDevelopmentsDP20:ProductideaDP01:Quotation handlingDP05:Customer TrainingDP06 MaintenanceSocietyDP21:CRDDP02:Order handlingDP08:Project assemblingAnd RepairTechnologyDP22:DesignDP03:Customer projectsDP09

12、:Standard assemblingLaws,Guidelines and RegulationsCo-makersDesign SupportAssembling SupportDP23:Design ControlDP10:LTP-purchasingDP13:WarehousingStandard productsDP11:PurchasingDP14:Module AssemblingCustomerDP12:Receipt of Goods DP15:IdentificationsatisfactoryInternal OrganisationImprovement toolsQ

13、uality HandbookDP38:Document controlDP28:Drawing UpdateDP30:Control of Basic FilesDP39:Network controlDP32:Disapproved materialsDP31:ESD-operationsDP40:Mail handlingDP33:ComplaintsDP34:Supplier selectionDP43:Hiring of PersonalDP47:Board AuditDP35:Internal ordersDP44:Study and educationDP48:Internal

14、auditsDP36:Control of ChemicalsDP45:Employee reviewDP37:Control of Measurement devices DP46:QA system managementcURSGAMPURS Signing and History Operational requirements Constrains Life cycle TestableGAMPPQP Signing and History Identification(personnel/equipment)Detailed instructions Acceptance criteria Defect listURS Applikons Questionair Bioreactor specification Control options Maintenance and cleaning ConstraintsSpecific examplecGMPQuestions?