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US FDA’s OPQ Aims To Clear The Way For Further Manufacturing Technology Advances in 2023

 
• By Bowman Cox

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.

Advanced pharmaceutical manufacturing
Advanced manufacturing is coming soon. • Source: Shutterstock

The Office of Pharmaceutical Quality in the US Food and Drug Administration’s Center for Drug Evaluation and Research is building on last year's efforts to help strengthen the continual quality improvement and supply chain resilience of drug products by facilitating use of advanced manufacturing technologies, OPQ director Michael Kopcha told the Pink Sheet.

The move is part of the agency’s efforts to pivot from its historically reactive and punitive compliance approach to an...

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