The Impact of Current Good Manufacturing Practices Inspections on Continuous Improvement Mindset in the Pharmaceutical Industry
Journal
Journal of Pharmaceutical Innovation
ISSN
1939-8042
Type
journal article
Date Issued
2025-10-29
Author(s)
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.
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.
Language
English
Keywords
• Quality Practices
Continuous Improvement Mindset
Inspection
Regulatory Science
Quality Management Maturity
Pharmaceutical Manufacturing
HSG Classification
contribution to scientific community
Refereed
Yes
Publisher
Springer Science and Business Media LLC
Volume
20
Number
6
Start page
282
Pages
19
Official URL
Contact Email Address
matteo.bernasconi@unisg.ch