Operational Excellence in Pharmaceutical Quality Control Labs: Driver of an Effective Quality System
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Scholars often associate Operational Excellence (OPEX) enablers with high operational performance. Several studies have concluded that advancing OPEX enablers helps improve organizational performance. This paper aims to better understand the relation between OPEX enablers and a robust quality control lab. Integral to pharmaceutical quality systems, robust quality control labs ensure effective drug provision to patients. We examine how implementing OPEX enablers in quality control labs contributes to strengthening quality effectiveness a pharmaceutical manufacturing organization.
The analysis was based on a database of the University of St.Gallen comprising 53 pharmaceutical quality control labs. An independent t-test and multiple linear regressions were used to study the relation between OPEX enablers and quality control lab effectiveness.
The results show that highly effective quality control labs exhibit significantly higher OPEX enabler implementation. Thirty-five percent of the variance in lab performance can be explained by enabler implementation.
High OPEX enabler implementation contributes to robust quality control labs achieving high-level quality and service. Organizations thus attain effective and efficient drug release.
KeywordsEmpirical study Enablers Quality control lab Operational excellence Pharmaceutical quality system
We particularly wish to thank Nuala Calnan, PhD, for her feedback throughout the research.
This research was conducted as part of the US Food and Drug Administration (FDA) research grant 1U01FD005675-01 awarded to the University of St.Gallen.
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