Xavier and PwC Metrics White Paper Now Available

In support of FDA’s intent to allocate its resources based on risk, Xavier University and PwC launched a Metrics Initiative in August 2014 to identify product quality risk metrics linked to patient safety that could be viewed during an inspection.

Xavier University and PwC led a team of 30 industry professionals that developed a framework of 11 metrics across the Total Product Life Cycle (TPLC). The framework is built upon driving a mindset of continuous improvement that includes feedback loops across the entire enterprise to design quality in product proactively at the source, instead of reactively catching bad quality after manufacture. The team recommends that this framework of metrics be incorporated into FDA’s inspection protocol as a roadmap for investigators to evaluate drug manufacturing and control operations during an inspection.