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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience.
July 02, 2021
A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
October 02, 2019
Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
August 01, 2018
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.