AI and Annex 22: Shaping the Future of Digital Manufacturing
Author: Nicola Rice, Head of Programmes
After an inspiring evening at the HBA Dublin Chapter event hosted by MSD Swords, where more than 75 industry leaders came together to discuss innovation and digital transformation, one theme was impossible to ignore: the future of manufacturing is digital.
Hearing Luke Kiernan of Innopharma Technical Services speak alongside peers from IDA Ireland, BioPharmaChem Ireland, and MSD Carlow highlighted an essential truth, technology alone doesn’t drive transformation, people do. Through lifelong learning, microcredentials, and collaboration, we’re building the skills to power the next era of manufacturing.
It struck me that the conversation couldn’t have been timelier. The European Commission recently released the newly drafted EudraLex Annex 22, the first regulatory framework focused on Artificial Intelligence (AI) in pharmaceutical manufacturing. It marks a pivotal moment: regulators formally recognising AI’s role in delivering quality, consistency, and efficiency across the product lifecycle.
AI in the GMP Environment
Annex 22 makes one thing clear, AI can be a valuable tool, but it must operate within the same GMP principles as any other system: data integrity, patient safety, and scientific control. It requires models to be explainable, validated, and continuously monitored, with human oversight remaining central to every decision.
Across the industry, we already see AI adding real value:
• Predictive maintenance reduces downtime and extends equipment life.
• Process optimisation improves yield and consistency through real-time analytics.
• Computer vision enhances product quality inspection.
• Deviation analytics identifies root causes faster.
• Digital twins allow simulation before change implementation.
Each use case reflects the balance Annex 22 promotes i.e. innovation anchored in quality.
Regulation Meets Innovation
Across the pharmaceutical industry, the pace of digital transformation is accelerating, yet innovation can only move as fast as the frameworks that guide it. That’s why the publication of EU GMP Annex 22 marks such a significant moment. It bridges the worlds of technology and regulation, setting out how manufacturers can adopt Artificial Intelligence responsibly, without compromising on quality or compliance.
Importantly, Annex 22 does not stand alone. Its introduction is accompanied by updates to Chapter 4, which strengthens controls around digital documentation and traceability, and Annex 11, which revises standards for computerized systems to reflect modern AI integration and align closely with Annex 22. Together, these revisions establish a harmonised, risk-based regulatory model designed to safeguard patient safety, product quality, and data integrity in an AI-powered pharma era.
At Innopharma Technical Services, this principle is already guiding how we work. We’re helping clients integrate AI and data-driven systems within validated, compliant frameworks, ensuring that innovation and quality move hand in hand. In parallel, we’re embedding AI awareness and application into our training programmes, equipping professionals with the digital and regulatory skills needed to thrive in this new landscape.
The Human Factor
As Luke emphasised during the HBA panel, digital transformation depends on people. Developing the skills to understand, validate, and manage AI systems is now a business priority. Through microcredentials and continuous education, the industry can close the digital skills gap and ensure technology enhances, not replaces, human expertise.
At Innopharma Technical Services, we see the intersection of education, compliance, and digital transformation as the key to sustainable innovation. Our teams support clients in adopting new technologies, ensuring that AI and data-driven systems meet both operational and regulatory standards.
Looking Ahead
Annex 22 signals a new chapter for pharma manufacturing, one that unites innovation and compliance. The question is no longer if AI will transform our industry, but how we ensure it does so responsibly.
Innopharma Technical Services is helping shape the future of manufacturing in a digital age, integrating AI and data-driven systems within GMP frameworks to bridge innovation and compliance, while building the skills, systems, and standards that define confident, capable, and compliant operations.
