FDA Raises Several Considerations for Use of AI in Drug Manufacturing
(Thursday, March 9, 2023)
Use of Artificial Intelligence (AI) is being explored for several aspects of manufacturing FDA regulated products which raises new concerns that must be considered according to a Discussion Paper released by FDA this week. FDA would like the industry to comment on these concerns so suitable regulatory policies can be created for such systems. There are four areas where AI can play a significant role: process design, process control, process monitoring, and handling of complaints and deviations. FDA’s key concerns are regarding the oversight of data handled by AI algorithms. From a regulatory point of view, AI programs are expected to be created by third parties that are responsible for managing the risk of AI in context of manufacturing monitoring and control. Many of the interactions between the AI system and process control may be automated complicating data traceability and may create cybersecurity and data integrity vulnerabilities. The AI systems would increase the amount of data generated during manufacturing, requiring changes to the existing data management practices regarding long-term storage of the data, data retrieval, analysis, and security. “AI could be used in various manufacturing operations such as monitoring and maintaining equipment, identifying areas for continuous improvement, scheduling and supply chain logistics, and characterizing raw materials.” The users of AI should implement measures to allow regulatory oversight of automated systems. Machine learning systems that adapt to real-time data should be compliant with the change control processes. The Discussion Paper highlights early questions about the use of AI in manufacturing. FDA acknowledges that AI systems are inevitable in manufacturing and would improve quality monitoring and improvement over long-term. And it wants to be there from the beginning so the regulators can adequately prepare for them.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC