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Human plasma for fractionation - plasma obtained by plasmapheresis intended solely for the recovery of proteins that are not labile in plasma., Australian Red Cross Lifeblood, CON-921
Product name
Human plasma for fractionation - plasma obtained by plasmapheresis intended solely for the recovery of proteins that are not labile in plasma.
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-921
Duration
The consent is effective from 3 March 2022 until the following condition no longer remains true.
Standard
The European Pharmacopoeia monograph Human plasma for fractionation (0853)
Non-compliance with standard
The product does not conform to the requirements of the European Pharmacopoeia
monograph Human plasma for fractionation (0853), in that plasma when obtained by
plasmapheresis, and intended solely for the recovery of proteins that are not
labile in plasma, is separated from cellular components and frozen in a chamber
at -20°C or below within 72 hours of collection rather than 24 hours.
Conditions imposed
This consent is limited to collection centres directly impeded by limited
product transport options for transporting plasma to a processing centre within
the required timeframe associated with the weather events occurring in NSW and
Qld in March 2022. This consent is effective until the implicated transport
options are resolved. Lifeblood must advise TGA when the transport options for
the affected collection centres have been resolved.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals