Regulatory Perspectives for AI/ML Implementation in Pharmaceutical GMP Environments

Integrating artificial intelligence (AI) and machine learning (ML) into pharmaceutical manufacturing processes holds great promise for enhancing efficiency, product quality, and regulatory compliance. However, implementing good manufacturing practices (GMP) in regulated environments introduces complex challenges related to validation, data integrity, risk management, and regulatory oversight. This review article comprehensively analyzes current regulatory frameworks and guidance for AI/ML in pharmaceutical Good Manufacturing Practice (GMP) settings, identifies gaps and uncertainties, and proposes considerations for future policy development. Emphasis is placed on understanding regulatory expectations across…