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US FDA's Surveillance Office Using Predictive Analytics To Measure Pharmaceutical Quality

 
• By Joanne S. Eglovitch

The US FDA used predictive analytics to mine data from 346 field alert reports to gauge the strength of manufacturers’ quality systems with the idea of using it to help set inspection priorities.

Back view of businesswoman working with advanced analytics in modern virtual technologies
FDA Pilots Predictive Analytics To Gauge Product Quality • Source: Shutterstock

The US Food and Drug Administration office that sets priorities for pharmaceutical good manufacturing practice inspections found in a recent pilot that it can mine field alert report data to help focus the agency's inspectorate on the facilities that tend to bungle root cause investigations.

The surveillance office in the agency's Office of Pharmaceutical Quality recently conducted a predictive analytics pilot that used information from field alert reports to measure pharmaceutical quality. High scores were...

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