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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

BLOOD DIRECTIVES

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CENTER for BIOLOGICS EVALUATION and RESEARCH (CBER)

LICENSING for BIOLOGICS

BLOOD AS A BIOLOGIC

BLOOD DIRECTIVES

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BLABIOLOGICS LICENSE APPLICATION ELA- ESTABLISHMENT PLA- PRODUCT

BLOOD DIRECTIVES

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GUIDANCE DOCUMENTS

CODE OF FEDERAL REGUALTIONS

TITLE 42CFR493

BLOOD DIRECTIVES

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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

BLOOD DIRECTIVES

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ESTABLISHMENT REGISTRATION

PRODUCT LISTING

DOMESTICFOREIGNEXEMPTIONS:

BLOOD DIRECTIVES

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BIOLOGIC PRODUCT STANDARDS

BLOOD REQUIREMENTS- GENERAL

BLOOD DIRECTIVES

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ADDITIONAL REQUIREMENTS

for BLOOD

BY PRODUCT TYPE WHOLE BLOODRED CELLSFFPPLATELETS

BLOOD DIRECTIVES

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DONORS

DONOR SUITABILITYHEALTH & HISTORY

COLLECTIONMETHODSTECHNIQUES

BLOOD DIRECTIVES

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PRODUCTS:

MODIFYING

PROCESSING

LABELING

BLOOD DIRECTIVES

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PRODUCT QC

STORING

SHIPPING

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TESTING STANDARDSSAMPLES

REAGENTS

TEST METHODS

BLOOD DIRECTIVES

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VARIANCES

EXAMPLE:

THAWED FFP EXPIRATION21 CFR 640.120 -606.122(m)(3

6 HOURS POST THAW24 HOURS POST THAW

BLOOD DIRECTIVES

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THE COALITION FOR BLOOD SAFETY

•AABB•AMERICA’S BLOOD CENTERS•AMERICAN RED CROSS •ARMED SERVICES BLOOD PROGRAM

BLOOD DIRECTIVES

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BLA EXAMPLES:

RED BLOOD CELLS

PLATELETS

BLOOD DIRECTIVES

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BLOOD DIRECTIVES