Implementing Enterprise Systems in GMP Areas to Ensure Defect-Free Production and Quality Assurance

Abstract

This Good Manufacturing Practice (GMP) regulations are essential for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. Implementing enterprise systems in GMP areas is crucial for achieving defect-free production and robust quality assurance. These systems, including Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS), integrate various aspects of production, from raw material procurement to final product distribution, enhancing data integrity, process control, and compliance. This paper explores the implementation of enterprise systems in GMP areas, detailing their impact on production efficiency and quality assurance. It discusses the benefits, challenges, and best practices associated with these systems. By adopting advanced enterprise systems, pharmaceutical companies can ensure high-quality production, reduce defects, and maintain compliance with regulatory standards..