Future outlook: how case studies may shape formal AI regulations Future outlook: how case studies may shape formal AI regulations Context As Artificial Intelligence (AI) technologies increasingly permeate Good Manufacturing Practices (GMP) environments, it’s essential for regulatory affairs professionals to understand how healthcare authorities are viewing the integration of AI into quality systems. The FDA, EMA, and MHRA are currently evaluating case studies that illustrate the benefits and potential risks of AI applications in manufacturing and quality assurance. This article will explore relevant regulations, guidelines, and agency expectations concerning AI in GMP settings. Legal/Regulatory Basis The regulatory landscape surrounding AI…