By Josefine Sommer, Christopher Fanelli, Eva von Mühlenen, Michelle Gandolfo, and Julea Lipiz, Sidley Austin LLP
Published in: Pharmaceutical Online Newsletter
Published on: June 4, 2024
In the pharmaceutical industry, the integration of artificial intelligence (AI) and machine learning (ML) into drug manufacturing processes is redefining how drugs are manufactured and controlled for quality. U.S. FDA Commissioner Califf recently stated that “AI has the potential to enable major advances in the development of more effective, less risky medical products.”1 AI and ML in good manufacturing practice (GMP) settings offer unprecedented opportunities to enhance operational precision, efficiency, accuracy, and compliance through advanced analytics and automation in a highly regulated field. However, they also introduce complex regulatory challenges that need to be navigated carefully.
This article provides insights into a variety of use cases on the application of AI and ML in GMP settings and useful considerations for manufacturers using AI in quality to demonstrate GMP compliance.
