US BLOOD DIRECTIVES
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US BLOOD DIRECTIVES
REGULATIONS FOR BLOOD and BLOOD PRODUCTS
JILL HOAGBS, SBB(ASCP) CQA(ASQ)AABB STAFF LEAD ASSESSOR
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DONOR and RECIPIENT SAFETYFROM COLLECTION TO TRANSFUSIONPRODUCTSTESTINGRECORDSSTAFF
BLOOD DIRECTIVES
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HEALTH and HUMAN SERVICESFDCAFDA
SAFETY
QUALITY
PURITY
POTENCY
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CENTER for BIOLOGICS EVALUATION and RESEARCH (CBER)
LICENSING for BIOLOGICSBLOOD AS A BIOLOGIC
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BLABIOLOGICS LICENSE APPLICATION ELA- ESTABLISHMENT PLA- PRODUCT
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GUIDANCE DOCUMENTSCODE OF FEDERAL REGUALTIONSTITLE 42CFR
493
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CODE OF FEDERAL REGUALTIONS
TITLE 21CFR 600-680
BLOOD DIRECTIVES
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cGMP (606)ORGANIZATION & PERSONNELFACILITYEQUIPMENTPRODUCTION & PROCESS CONTROLS
FINISHED PRODUCT CONTROLSLAB CONTROLSRECORDS & REPORTS
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ESTABLISHMENT REGISTRATION
PRODUCT LISTING
DOMESTICFOREIGNEXEMPTIONS:
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BIOLOGIC PRODUCT STANDARDS
BLOOD REQUIREMENTS- GENERAL
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ADDITIONAL REQUIREMENTS for BLOOD
BY PRODUCT TYPEWHOLE BLOODRED CELLSFFPPLATELETS
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DONORSDONOR SUITABILITYHEALTH & HISTORY
COLLECTIONMETHODSTECHNIQUES
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PRODUCTS:
MODIFYING
PROCESSING
LABELING
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PRODUCT QC
STORING SHIPPING
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TESTING STANDARDSSAMPLES
REAGENTS
TEST METHODS
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VARIANCES
EXAMPLE: THAWED FFP EXPIRATION21 CFR 640.120 -606.122(m)(3
6 HOURS POST THAW24 HOURS POST THAW
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THE COALITION FOR BLOOD SAFETY
•AABB•AMERICA’S BLOOD CENTERS•AMERICAN RED CROSS •ARMED SERVICES BLOOD PROGRAM
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BLA EXAMPLES:
RED BLOOD CELLS
PLATELETS
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BLOOD DIRECTIVES