Pharma groups use quality metrics to monitor their own quality and identify areas to improve. FDA will soon be requesting this valuable data and making use of it – a revision to the FDA’s draft guidance on quality metrics is planned still for 2016.
FDA plans to use this data “…to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”
Check out this article where Zachary Brennan, RAPS, summarizes a list of the types of data the agency will be looking for.