By Sarah Beale, MasterControl
COVID-19 had a dramatic impact on the inspectional activities of the U.S. Food and Drug Administration (FDA). The number of good manufacturing practices (GMP) inspections that could be completed understandably decreased and the agency found itself relying more on remote methods. While FDA oversight now looks quite different than before the pandemic, the biggest problem in FDA GMP inspections hasn't changed.
When it comes to pharmaceutical manufacturing, year after year, the same problem is at the top of the list for both FDA warning letters and Form 483s — issues involving quality responsibilities and procedures. We uncover how embracing digitization and adopting an eQMS to manage quality processes can make this problem a thing of the past.