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1、Bioreactor design for animal cell cultures: cGMP aspects A 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 mana
2、gement 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 M
3、aterials Procedures 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 describe
4、d in 21 CFR 210 en 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 mus
5、t be adapted to the specific 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 Scienc
6、e” to be implemented It 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
7、 assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.cGMPIntegrate with Validation Documentation as appropriateSUPPLIERFunctional Specification (traceable to URS)USER/(CONSULTANT if applicable)Master Validation PlanRF
8、QUser AuditProposal Project Plan Quality & Validation PlanEquipment Validation Plan Explanation to SupplierUser Requirements Specification (Living Document)Proposal AnalysisProposalP.O.Detailed Design Documentation (traceable to Functional Specification)Review Functional SpecificationReview Detailed
9、 DesignSystem Acceptance Test Specifications (IQ/OQ) Hardware SoftwareReview System Acceptance Test SpecificationsSystem Acceptance Testing and Results User Witness OptionalApprovalApprovalApprovalEngineering Feasibility Study and ResultsP.O.GAMPGAMPGAMPURS 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 ?
