生物反应器课件Bioreactordesignforanimalcellcultures：cGMPaspects.ppt

Bioreactor design for animal cell cultures: cGMP aspects,A supplier perpective,Content,cGMP in equipment cGMP guidelines cGMP design rules cGMP in practice cGMP in documentation,Applikon Biotechnology,Specialists in electronic and mechanical engineering Process engineering Project engineering and management Hygienic processing G(A)MP Validation Documentation,Applikon Biotechnology,Applikon Biotechnology,cGMP,cURRENT Good Manufacturing Practice in Bioreactor design,International standards,cGMP HAZOP ISO 9000 Design codes CE / ASME /CSA International pressure codes: CE / ASME / CSA / JIS,ASME BPE 2009,Materials Procedures Hygienic design Welding Surface finishing,cGMP,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 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 controls,cGMP,GMP are guidelines and not clear specifications GMP documents are not defined Examples are available, but must 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 improvement,cGMP,Deliberate vagueness Allows innovative ideas based upon “Good Science” 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 practice,cGMP,Validation Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.,cGMP,GAMP,GAMP,GAMP,URS,Signing and History Operational requirements Constrains Life cycle Testable,GAMP,PQP,Signing and History Identification (personnel/equipment) Detailed instructions Acceptance criteria Defect list,URS,Applikons Questiona