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Anvisa ends inspection at AstraZeneca factory

Inspectors await additional data to draft a report
Pedro Peduzzi
Published on 11/12/2020 - 15:07
Brasília
Logo da AstraZeneca em Macclesfield, na Inglaterra
© Reuters/Phil Noble/Direitos Reservados

Brazil’s national sanitary regulator Anvisa today (Dec. 11) is ending its in-loco inspection initiated on Monday (7) at Chinese company Wuxi Biologics, tasked with the manufacture of biological active supplies used by Fiocruz in the production of vaccine AstraZeneca/Oxford.

The inspectors sent to China to check on the practices adopted in the production of supplies await a response from Wuxi Biologics regarding additional data requested, before they can draft a report. Only then is the certification process concluded.

In a note, Anvisa reports that the certificate of good practices in manufacture is ready by the first half of January.

Yesterday (10), Anvisa approved a resolution making it possible “for laboratory to request authorization for the experimental emergency use of vaccines against COVID-19.”

The decision formalizes the request for emergency use announced on December 2 by the watchdog itself.