Analysis of the effects of Operational Excellence implementation on Inspection Outcomes in the Pharmaceutical Industry: An Empirical Study

Abstract

Goal: The goal of this paper is to test the possible connection between pharmaceutical manufacturing plants’ Operational Excellence implementation and regulatory inspection outcomes. Methodology: This paper uses logistic regression models on a unique dataset compiled from proprietary operations datasets and published FDA inspection outcomes. Results: The findings show that sites with advanced Operational Excellence implementation are more likely to receive favorable inspection outcomes and more so when specifically focusing on Total Quality Management implementation as a subset. A similar trend exists for the Quality Control laboratories and their compliance deficiencies when analyzed separately. Limitations of the investigation: The limitations of this research mainly lie in the limited size and composition of the available dataset. European manufacturing sites and quality control labs are overrepresented and the sample size for quality control labs is rather small. Practical Implication: This paper can help industrial managers and regulatory officials to better direct their resources to manufacturing sites and QC laboratories that are at a higher risk of quality non-compliance. Originality/value: It is a long-standing maxim in literature and practice that manufacturing sites shall build improvement capabilities to reach Operational Excellence which includes superior product quality. Quality Management is particularly important in the pharmaceutical industry and often evolves on its own in the organizations. Pharmaceutical production plants are inspected regarding their quality processes and systems by regulatory authorities. However, there is lacking published evidence of the interplay of Operational Excellence practices and regulatory inspection outcomes.

Keywords

• Pharmaceutical Industry
• Operational Excellence
• Total Quality Management
• Regulatory Inspection Outcomes
• FDA Food and Drug Administration