Options
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience
Journal
AAPS Journal
ISSN-Digital
1550-7416
Type
journal article
Date Issued
2022
Author(s)
Fellows, Matt
Li, Ye
Maguire, Jennifer
Rakala, Nandini
Ritz, Marten
Seiss, Mark
Stiber, Neil
Swatek, Mat
Viehmann, Alex
Abstract (De)
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.
Language
English
HSG Classification
contribution to practical use / society
HSG Profile Area
SoM - Business Innovation
Refereed
Yes
Publisher
Springer
Volume
24
Number
6
Pages
11
Official URL
Subject(s)
Division(s)
Eprints ID
267654