Good Manufacturing Practices (GMPs) - SEABB

good Manufacturing Practices (GMPs) More than a few Numbers !Where Do We Find Them? Depends on what you Are you looking for good Manufacturing Practices for Blood and Blood Products Tissues (HCT/Ps) Drugs Laboratory Practices AgricultureWhere Do We Find Them? GPO Access A Z Resource List Code of Federal Regulations US Government BookstoreGood Practices21 CFR 5821 CFR 11021 CFR 21021 CFR 21121 CFR 60621 CFR 82021 CFR 1271 good Practices21 CFR 58 -Laboratory21 CFR 110 Water (food)21 CFR 210 -Drugs21 CFR 211 Drugs21 CFR 606-Blood21 CFR 820 -Devices21 CFR 1271-TissueAssumptionsAudience : Blood Banks / good Manufacturing PracticesARE NOTT otal procedureOnly way to manage a processAREC ross Functional FrameworkChecklist for what you needOutline for procedures development21 CFR PART 606 Current good Manufacturing Practice for Blood and Blood ComponentsPart 606 Blood & Blood Provisions & & (for growing pains) & Process Product ControlsPart 606 (con t)I. Records and ReportsPart 606 Subpart A Definitions Blood Unit Component Plasma for further mfg Plasmapheresis Plateletpheresis Leukapheresis Facilities Processing Compatibility Testing Distributed ControlDistributed(1)The blood or blood components have left the control of the licensed manufacturer, unlicensed registered blood establishment, or transfusion service; or(2)The licensed manufacturer has provided Source Plasma or any other blood component for use in the Manufacturing of a licensed biological ()

Where Do We Find Them? • Depends on what you want…. • Are you looking for good manufacturing practices for – Blood and Blood Products – Tissues (HCT/Ps)

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