Drug Makers Share Best Practices For Preparing for Drug Recalls
This article was originally published in The Gold Sheet
Drug manufacturers can manage recalls better by strengthening their standard operating procedures, conducting mock recalls and developing robust distribution databases, experts told a recent conference in Bethesda, Md.
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A deluge of drug recalls set a record in 2009. With the past four years now among the top five for recalls, it suggests drug quality could be in a period of decline. Last year's record reflects GMP breakdowns at a drug repacker and several manufacturers that were identified during FDA inspections and led to a variety of sanctions, including warning letters, consent decrees and an import alert. Congress is looking to let FDA mandate recalls, which means the rain of recalls could grow even heavier. Meanwhile, FDA adds suspensions to its enforcement arsenal. International recalls remain rare, though that could change as FDA ramps up enforcement abroad
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.