Innovative Approaches to CAPA and Change Control in the Pharmaceutical Industry

ABSTRACT: The implementation of Corrective and Preventive Actions (CAPA) and Change Control is crucial in the pharmaceuticalindustry to ensure product quality, regulatory compliance, and patient safety. This paper explores the systematic approaches for establishing effective CAPA and Change Control processes, emphasizing their roles in identifying root causes of deviations, mitigating risks, and facilitating continuous improvement. By integrating CAPA and Change Control within the quality management system, pharmaceutical organizations can enhance operational efficiency and maintain compliance with industry regulations. Case studies highlight successful implementations and the resulting positive impacts on production quality and organizational resilience. The findings underscore the necessity of a proactive culture that prioritizes transparency, accountability, and collaboration across all levels of the organization.