IFPMA – AI in Pharmaceutical Manufacturing

Date

March 4, 2026

Category

EU Regulations

Description

On 4 March 2026 the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a paper titled “Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation”, see https://www.ifpma.org/publications/artificial-intelligence-in-pharmaceutical-manufacturing-navigating-innovation-and-regulation/.  This paper identifies the potential applications of AI in manufacturing to:

• Increase agility and efficiency
• Enhanced accuracy and innovation
• Improve quality assurance performance

Importantly, this paper calls for international harmonisation of the regulation of the use of AI by building on existing ICH guidelines Q8 to 10.  The paper states “In principle, the field of AI in pharmaceutical manufacturing, which is emerging and has few existing guidance, offers a unique opportunity for early alignment, as opposed to addressing diverging rules later.”  The paper sees the EU-PIC/S Annex 22 as being more prescriptive than other draft guidelines.  IFPMA does, however, welcome the recently published joint EMA/FDA guidance on the use of AI in pharmaceutical development.

The paper says that that machine learning can be readily used by sponsors to predict reality, for example by predicting the yield of a monoclonal antibody manufacturing process. Those methods involve creating so-called “digital twins,” which are digital models of an entire manufacturing process or of an individual step in a process.  Digital twins can either be used either as part of the system that controls the manufacturing process, or outside of it – for example, to help plan and schedule production runs.