VIV Podcast

Quality Management Maturity – A Pilot Program of the FDA

Late last year the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aide in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them. This week we catch up with the team from FDA to discuss the progress and impacts of this pilot, as well as the intended implementation for future reach.

Resources from this episode:




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