Evaluating the Role of ICH Q9-Based Quality Risk Management in Reducing CAPA Recurrence Rates: A Study of GMP-Regulated Pharmaceutical Companies in Ireland

Abstract

This research examines the contribution that Quality Risk Management (QRM) under the ICH Q9 framework can make to resolving the long-standing problem of recurring Corrective and Preventive Actions (CAPAs) in Irish pharmaceutical manufacturing. Even with good regulatory management that is seen with EU GMP, the repeated occurrence of problems within many sites remains to be a source of disappointment to product quality and efficiency within the operations. This research study conducted a systematic survey of 109 quality professionals to investigate the maturity of QRM practices in use, perceived utility of QRM tools, and the degree to which regulatory alignment can be used to impact the results of CAPAs. The results point out that greater QRM maturity is strongly linked to increased CAPA success and lower recurrence. The respondents in the locations that have high integration of QRM practices gave higher ratings to the effectiveness of CAPA processes and those with low levels documented recurring issues. The regression analysis also showed that the alignment of regulatory practices to the EU GMP and ICH Q9 regulations significantly affected the decline of CAPA recurrence, but the actual presence of formal QRM policies did not cause significant difference. The work has academic and practical contributions by highlighting the importance of a better integration of QRM into CAPA investigations, as opposed to policy-based adoption. Practitioner recommendations to the industry, as well as academic recommendations on the longitudinal effects, are given.