Shaping the Future of Pharmaceutical Manufacturing Quality: From Quality Metrics to Quality Management Maturity and Beyond
Journal
American Pharmaceutical Review
ISSN
1099-8012
Type
journal article
Date Issued
2023
Author(s)
Abstract
Quality 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.
Language
English
HSG Classification
contribution to practical use / society
HSG Profile Area
SoM - Business Innovation
Refereed
No
Publisher
American Pharmaceutical Review
Volume
26
Number
2
Subject(s)
Division(s)
Eprints ID
269495