FDA Quality Metrics Research Final Report

The FDA Quality Metrics initiative has emerged directly from the FDA Science and Innovation Act (US Congress, 2012) (FDASIA, 2012) and aims to provide both industry and regulators with better insight into the current state of quality across the global pharma- ceutical manufacturing sector that serves the American publics’ healthcare needs. As part of this initiative the FDA awarded a research grant to the University of St.Gallen to help establish the scientific base for rele- vant performance metrics which might be useful in predicting risks of quality failures or drug shortages. An important factor in the academic collaboration for this research was the availability of the St.Gallen Pharmaceutical OPEX Benchmarking database, consisting of key performance indicator and enabler data related to more than 330 pharmaceutical manufacturing sites. This report provides an account of the research activities, initial data analysis undertaken and key findings arising from the first year of this research program. The research has progressed into year two.