Reducing Defects in Pharmaceutical Processes Through Enterprise Systems and Corrective and Preventive Actions (CAPA)
Omar Al-Hassan
Fatima Al-Mahmoud
Abstract
Pharmaceutical manufacturing is a highly regulated industry where product quality and safety are paramount. Reducing defects in pharmaceutical processes is critical to ensure the efficacy and safety of medications. Enterprise systems, integrated with Corrective and Preventive Actions (CAPA) frameworks, offer robust solutions for managing and mitigating defects in pharmaceutical production. These systems streamline operations, enhance data accuracy, and ensure compliance with regulatory standards. CAPA frameworks identify root causes of defects and implement systematic measures to prevent recurrence. This paper explores the integration of enterprise systems and CAPA in pharmaceutical processes, detailing their impact on defect reduction. Through case studies and analysis, the paper demonstrates how these technologies and methodologies can lead to significant improvements in product quality and operational efficiency. Best practices for implementation and continuous improvement are also discussed, providing a comprehensive guide for pharmaceutical companies aiming to enhance their quality management systems.
Author Biographies
Omar Al-Hassan
Omar Al-Hassan
Department of Computer Science, Qatar University, Qatar
Fatima Al-Mahmoud
Fatima Al-Mahmoud
Department of Computer Science, University of Jordan, Jordan
