Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience

Item Type Journal paper
Abstract 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.
Authors Fellows, Matt; Friedli, Thomas; Li, Ye; Maguire, Jennifer; Rakala, Nandini; Ritz, Marten; Bernasconi, Matteo; Seiss, Mark; Stiber, Neil; Swatek, Mat & Viehmann, Alex
Journal or Publication Title AAPS Journal
Language English
Subjects business studies
health sciences
HSG Classification contribution to practical use / society
HSG Profile Area SoM - Business Innovation
Refereed Yes
Date 2022
Publisher Springer
Volume 24
Number 6
Number of Pages 11
ISSN-Digital 1550-7416
Publisher DOI https://doi.org/10.1208/s12248-022-00761-7
Official URL https://rdcu.be/cXY2A
Depositing User Matteo Bernasconi
Date Deposited 21 Oct 2022 09:03
Last Modified 25 Oct 2022 07:20
URI: https://www.alexandria.unisg.ch/publications/267654

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Fellows, Matt; Friedli, Thomas; Li, Ye; Maguire, Jennifer; Rakala, Nandini; Ritz, Marten; Bernasconi, Matteo; Seiss, Mark; Stiber, Neil; Swatek, Mat & Viehmann, Alex (2022) Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience. AAPS Journal, 24 (6).

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https://www.alexandria.unisg.ch/id/eprint/267654
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