A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
Marzena Ingram
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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.
Articles by Marzena Ingram
Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
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Latest Updated Articles
Assessing Legacy Drug QualityPublished: July 2nd 2021 | Updated:
Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationPublished: August 1st 2018 | Updated:
Lessons from FDA 483s and cGMP Inspection DataPublished: October 2nd 2019 | Updated:
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