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Matteo Bernasconi
Last Name
Bernasconi
First name
Matteo
Email
matteo.bernasconi@unisg.ch
ORCID
Phone
+41 71 224 72 71
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1 - 4 of 4
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PublicationShaping the Future of Pharmaceutical Manufacturing Quality: From Quality Metrics to Quality Management Maturity and BeyondQuality excellence is a key factor in pharmaceutical manufacturing that differentiates the high performers from the less successful companies. Quality Metrics research identified that ‘high performer’ manufacturing plants excel for most Pharmaceutical Quality System (PQS) effectiveness metrics, achieve this with lower inventory levels, all while handling more Stock Keeping Units (SKUs).6 On the other hand, the research also confirms that manufacturing plants with low PQS excellence, report a higher share of indirect QA/QC labor full time equivalents (FTEs), in response to underlying operational stability problems. Quality Excellence is described as an advanced approach to quality which goes beyond merely being compliant with regulations. Quality excellence is patient-driven, culturally embedded and built into the processes and behavior of an organization. This article provides an overview of quality metrics research undertaken by the authors on behalf of FDA and the development of a machine learning based, predictive risk surveillance model.Type: journal articleJournal: American Pharmaceutical ReviewVolume: 26Issue: 2
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PublicationThe Role of Social and Technical Lean Implementation in Improving Operational Performance: Insights from the Pharmaceutical Industry(World Academy of Science, Engineering and Technology, 2023)The objective of this paper is to examine the relationships between technical and social lean bundles as well as operational performance in the context of the pharmaceutical industry. We investigate the direct and mediating effects of the lean bundles Total Productive Maintenance (TPM), Total Quality Management (TQM), Just-In-Time (JIT), and Human Resource Management(HRM) on operational performance. Our analysis relies on 113 manufacturing facilities from the St.Gallen OPEX benchmarking database. The results show that HRM has a positive indirect effect on operational performance mediated by the technical lean bundles.Type: journal articleJournal: International Journal of Industrial and Manufacturing EngineeringVolume: 17Issue: 2
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PublicationBenchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience(Springer, 2022)
;Fellows, Matt ;Li, Ye ;Maguire, Jennifer ;Rakala, Nandini ;Ritz, Marten ;Seiss, Mark ;Stiber, Neil ;Swatek, MatViehmann, AlexType: journal articleJournal: AAPS JournalVolume: 24Issue: 6 -
PublicationType: journal articleJournal: Level 3Volume: 16Issue: 1