FDA Quality Metrics Research Final Report Year 2

This report, building upon the findings of the first year of the research project provides an account of the research activities undertaken in the second year and presents an outlook for future research on this topic. In terms of structure, Chapters 2 and 3 of this report describe the background and research-design. Chapter 4 then eintroduces the reader to the basic elements of the Pharmaceutical Production System Model (PPSM), which was developed in year one to structure the data capture and data analysis to meet the goals of the research. In Chapter 5, the validity of the PPSM is tested against a range of reported internal company compliance findings and also against a public database of FDA regulatory inspection outcomes/ final decisions. Chapter 6 examines patterns observed between the high and low performing manufacturing plants. The focus in Chapter 7, turns to the role of the QC labs and QC lab excellence. Penultimately, Chapter 8 discusses St. Gallen’s perspective on the research implications arising from the year 2 findings for FDA, for the research team and for the pharmaceutical industry. While finally, Chapter 9 summarizes the insights gained in year 2 and provides an outlook to future work recommended.