The Impact of Current Good Manufacturing Practices Inspections on Continuous Improvement Mindset in the Pharmaceutical Industry
Year: 2025
Type: article
Abstract: Purpose Regulatory inspections ensure consumer safety and product quality. In tightly regulated industries, compliance and organizational improvement efforts must align to achieve operational excellence. This study examines how surveillance current good manufacturing practice (CGMP) inspections influence the relationship between quality management practices and a continuous improvement mindset at pharmaceutical manufacturing facilities. Methods The study builds on a regression analysis of pooled cross-sectional data from drug manufacturers and the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), supplemented by ten interviews with operational excellence leaders. Results Quality management practices catalyze continuous improvement. Inspections may provide useful external nudges in this context; however, the results suggest that their frequency should be carefully planned. In particular, we observe that a moderate frequency of CGMP inspections has the potential to support quality management efforts, whereas longer frequencies show a negative interactive effect. CGMP inspections validate quality management improvements and foster further improvements; however, this effect decays over time. Conclusion Regulatory agencies must carefully plan their surveillance inspection scheduling. If more frequent surveillance inspections are not feasible, they should consider complementing them with other initiatives —such as the Quality Management Maturity program—to further support the enhancement of quality practices and extend the duration of their positive effects on manufacturers.
Institutions: University of St.Gallen, ETH Zurich
Language: English
Subfield: Strategy and Management
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $3,990
Funder: Universität St. Gallen
OpenAlex ID: W4415664456