Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience.
Matt Fellows, Thomas Friedli, Ye Li, Jennifer Maguire, Nandini Rakala, Marten Ritz, Matteo Bernasconi, Mark Seiss, Neil Stiber, Mat Swatek, Alex Viehmann
Author Information
Matt Fellows: Dun and Bradstreet, 101 JFK Parkway, Short Hills, New Jersey, 07078, USA.
Thomas Friedli: University of St. Gallen, Dufourstrasse 50, 90000, St. Gallen, Switzerland.
Ye Li: FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Jennifer Maguire: FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Nandini Rakala: FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Marten Ritz: University of St. Gallen, Dufourstrasse 50, 90000, St. Gallen, Switzerland.
Matteo Bernasconi: University of St. Gallen, Dufourstrasse 50, 90000, St. Gallen, Switzerland.
Mark Seiss: Dun and Bradstreet, 101 JFK Parkway, Short Hills, New Jersey, 07078, USA. seissm@dnb.com.
Neil Stiber: FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Mat Swatek: Dun and Bradstreet, 101 JFK Parkway, Short Hills, New Jersey, 07078, USA.
Alex Viehmann: FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Over the past several decades, pharmaceutical manufacturing has become increasingly global and supply chains have become longer, more complex, and fragmented. While pharmaceutical products available to patients and customers typically conform with appropriate standards, supply chains are often affected by disruptive events and shocks that impact public health. One approach to assuring the availability of quality pharmaceutical products is to encourage drug manufacturers to invest in quality management maturity (QMM) and promote continual improvement. The interests of patients are served by risk-based drug shortage prevention and mitigation activities that help to proactively manage supply chain complexities and ensure availability of drugs. This paper demonstrates that adherence to certain quality practices enables improved manufacturing performance. Prior research has identified quality practices that are correlated with manufacturing performance. To better understand how these quality practices can be characterized, measured, and analyzed, this research project conducted a voluntary global study of pharmaceutical manufacturing establishments. Over 200 global pharmaceutical manufacturing establishments participated in this Quality Benchmarking Study (QBS) and provided data on manufacturing performance and self-assessments of adherence to quality practices. The analysis of these data found that the implementation level for selected quality management practices correlates positively with certain Key Performance Indicators (KPIs). More specifically, we found a significant positive correlation between (i) Delivery Performance and (ii) Application of QMM principles associated with Technical Production.
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