How US FDA’s Pharma Quality Office Fared In Pandemic’s Second Year
OPQ Director Kopcha looks back at a year that travel restrictions made especially challenging for application reviews, site surveillance, IT support and sleep. And ahead to new challenges around supply chain transparency and resilience.
You may also be interested in...
As the agency's Office of Pharmaceutical Quality releases its annual report highlighting last year's efforts to advance distributed and point-of-care manufacturing, OPQ director Kopcha tells the Pink Sheet of plans to focus on activities advancing the use of artificial intelligence in manufacturing process control this year.
Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented inspections.
Academics assert more should be done to restore pre-pandemic site-inspection activity levels, especially abroad, following analysis of 10 years of data on US FDA inspection trends, costs and resources published in Health Affairs.