Blood Products Advisory Committee June 20, 2003 Kay R. Gregory, MS, MT(ASCP)SBB
AABB Task Force on Recovered Plasma • • • AABB ABC ARC BCA ASBPO
Background – Recovered Plasma • Outdated terminology • Outdated system of regulation
Proposed Licensing Requirements
Product Name Plasma for Manufacture
Donor Qualification • Same as allogeneic Whole Blood • Collected concurrently with cellular products for transfusion/by apheresis 3/10/95 FDA Memorandum “Revision of FDA Memorandum of August 24, 1982: Requirements for Infrequent Plasmapheresis Donors”
Method of Preparation 1. Separate plasma from Whole Blood 2. Infrequent plasmapheresis w/automated collection of cellular products for transfusion/infrequent plasmapheresis 3. Convert plasma for transfusion (e. g. FFP) to Plasma for Manufacture
Method of Preparation, cont’d • Plasma for Manufacture by separation from WB anytime during dating period for WB • Plasma for transfusion converted to Plasma for Manufacture anytime during dating period/up to 1 yr. after outdate as transfusible component
Expiration Date 2 years from date of collection
Testing for Infectious Disease Same requirements as Whole Blood except: • Negative result for Anti-HBc not required • Negative result for Anti HTLV I/II not required
Labeling: Product Name “Plasma for Manufacture”
Labeling: Statement of Freezing Time “Frozen Within _____ Hours After Phlebotomy”
Labeling: Caution Statement “Caution: For Manufacturing Use Only into Injectable Products”
Labeling: Product Code From Uniform Labeling Guidelines or ISBT 128
Labeling: Amount Total volume or weight of plasma
Labeling: For Whole Blood-Derived Plasma for Manufacture Name and volume of source material, e. g. , “From 500 m. L CPD Whole Blood”
Labeling: For Plasma for Manufacture Collected by Plasmapheresis Total type and volume of anticoagulant used
Labeling: Storage Temperature -18 C or colder
Labeling: Facility Identification • Name, address, license number of collection facility • Name, address, license number of institution where separated (if different than collection facility)
Labeling: Testing Statement “Negative by FDA required tests”
Labeling: Collection Date Month, date and year
Component Retrieval Same as required by FDA for Source Plasma or recovered plasma
Records Retained for 10 years
Freezing • Not within a specific time frame. Instead… • Specify time on label so fractionator can determine suitability for intended use
Short Supply Agreements No longer necessary when Plasma for Manufacture becomes available
Collection/Expiration Dates • Now: Collection date on recovered plasma label • Continue this practice, but… • Acceptable to require expiration date instead of collection date when expiration date established for Plasma for Manufacture
Additional considerations • Adequate time to obtain license • Abbreviated application process
Plasma for Manufacture Working together… We can make it happen.
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