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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
ARTG
Consent start
Consent no.
CON-921
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.      
Therapeutic product type
Blood, tissues, and biologicals

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