The FDA Quality Metrics Research started in July 2016 with a 1-year grant and has been extended to a second and third year (until June 2019). The research project is funded by the US Food and Drug Administration (FDA). Among other tasks, FDA monitors and inspects pharmaceutical manufacturing sites. By inspecting pharmaceutical manufacturing sites. FDA aims at ensuring effective drugs and patience safety.
Project Relevance and Vision
Recently, a general trend toward an increasing number of recalls and warning letters in the pharmaceutical industry can be observed. An effective pharmaceutical quality management system serves as the basis to address the outlined issue and enables an organization to provide effective and safe treatments to its patients.
The FDA Quality Metrics Research is the scientific basis of the FDA-driven so-called Quality Metrics Initiative that aims at moving the industry toward effective pharmaceutical quality management systems. FDA intends to use the research of the University of St.Gallen as a scientific basis for the risk-based pharmaceutical quality system assessments. The key objective of the research is to identify relevant pharmaceutical manufacturing performance metrics to assess the current state of quality and to predict risks of quality failures and drug shortages. In the future, this may enable FDA to employ a risk-based inspection scheduling by assessing the performance metrics in combination with the risk profile of manufacturing sites. Additionally, it may enable FDA to better allocate its limited resources to those sites that should be inspected due to potential risk. It may also enable FDA to conduct inspections more efficiently by incorporating quantitative data beside qualitative data as of today.
Research Background and Approach
The St.Gallen Operational Excellence Benchmarking Database represents the basis for the research project. For further details on our OPEX benchmarking please click here.
Research Outcomes and Impact
The insight gained from the research to date highlights the complexity of pharmaceutical quality management systems and the importance of understanding the numerous interdependencies between key enablers and their impact on performance outcomes from an overall system perspective.
Please download the Year 1 and Year 2 St.Gallen FDA Quality Metrics Research Final Reports below to find all details on the research findings.