Deviation Management And CAPA Evolution In API Manufacturing: Toward A Digitally Transformed Future

Abstract

The review explores the trends, problems, and developments in the management of deviations and Corrective and Preventive Actions (CAPAs) in Active Pharmaceutical Ingredient (API) manufacturing. This analysis underscores the essential function of effective deviation management systems in upholding compliance, guaranteeing product quality, and mitigating risks through the examination of historical changes, statistical data, and case studies. The essay examines legal consequences and suggests future approaches, including the use of new technologies such as AI, digital transformation, and blockchain, to improve proactive and efficient CAPA processes. These innovations are crucial for enhancing operational excellence and conforming to changing regulatory norms.