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US FDA Pharmaceutical Quality Operations Chief Outlines Paths To Quicker Inspections

 
• By Bowman Cox

As US pharmaceutical inspectorate advances toward pre-pandemic inspection cadence, there's new focus on accelerating site inspection process, as well as effort to improve retention with quicker, more targeted training. OPQO chief Alonza Cruse reviews key ideas at GMP conference.

time for inspection
• Source: Shutterstock

The US Food and Drug Administration is working to inspect drug manufacturing facilities more quickly with workers who are trained more quickly to accelerate a pharmaceutical manufacturing inspection program that is still recovering from the COVID-19 pandemic.

An inspection backlog that built up when investigators with the FDA’s Office of Regulatory Affairs were grounded for months during the global public health emergency has stubbornly persisted.

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