Artificial Intelligence is reshaping global healthcare but, for the pharmaceutical sector, this represents not only a technological leap but a call for stronger regulatory alignment, ethical oversight, and human accountability.
The draft EU GMP Annex 22 marks a pivotal evolution in how Artificial Intelligence is integrated into regulated pharmaceutical environments. Rather than fast-tracking automation, it sets out when and under what controls AI can operate within GMP-critical processes.
“Although still at its first draft, its message is clear: AI must never compromise patient safety, product quality, or data integrity,” says Corinne Zaffarese Elbourne, Regulatory Affairs and Quality Unit Manager at Vivian who recently attended the European GMP & GDP Forum in Barcelona.
“Models must be validated, performance continuously monitored, and governance transparent. The human in the loop: as reviewer, approver, and ultimate decision-maker, remains central,” she added.
While Annex 22 sets the tone for Europe, other regions are advancing rapidly. The US FDA’s 2025 draft Guidance for Industry, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making,” proposes a risk-based framework for validating AI models in drug development, showing how AI will soon form the backbone of data integrity and scientific evidence generation.
In parallel, the White House’s “Winning the Race: America’s AI Action Plan” charts a national roadmap for AI-enabled science and healthcare innovation.
This vision is reinforced across the Atlantic, as the UK and US have also forged a landmark pact to accelerate AI-driven drug discovery and healthcare innovation. Under the transatlantic agreement, the two nations are committing significant investment and collaboration to strengthen AI infrastructure, advanced computing, and joint research in life-sciences
In Europe, innovation is coupled with accountability. The EU Pharmaceutical Package and the EU AI Act together will lay the groundwork for a digital-ready sector where AI enhances patient safety, supply-chain resilience, and sustainability. Annex 22 bridges policy and practice, guiding how AI can improve manufacturing and quality oversight without displacing human control.
For distribution companies such as Vivian Corporation, the implications are equally profound.
The same principles that govern AI in GMP: risk-based control, traceability, and data governance, are expanding into Good Distribution Practice (GDP) environments.
AI-driven predictive temperature management, deviation trending, and intelligent demand forecasting will help distributors anticipate challenges, strengthen business continuity, and reduce waste. Yet human oversight will remain the anchor of every decision.
“AI will not replace quality systems,” notes Corinne Zaffarese Elbourne, “but it will redefine how we apply them, turning data into actionable intelligence and allowing distributors like Vivian to operate with greater foresight, precision, and efficiency.”
Vivian’s long-standing commitment to regulatory excellence was reaffirmed during its Annual Refresher Training on Good Distribution Practice (GDP) and Pharmacovigilance, led by the company’s Regulatory Affairs and Quality Assurance team.
Corinne Zaffarese Elbourne, Leanne Bason, and Shanice Mifsud oversee Vivian’s operations to ensure that every product meets the strictest local and international standards.
“The annual training session is a cornerstone in Vivian’s quality framework,” explains Leanne Bason, who led this year’s session.
“It keeps employees aligned with the latest regulatory expectations and reinforces our culture of excellence.”
Leanne Bason emphasised that compliance is not static but evolves with science, technology, and patient needs. “At Vivian, refresher training is more than fulfilling an obligation, it strengthens our collective understanding of why what we do matters.”
Shanice Mifsud added, “training also connects every employee to Vivian’s broader purpose because in the end, it is not only about compliance but about maintaining the trust that patients and healthcare professionals place in us every day.”
As the regulatory context grows in complexity, Vivian continues to embrace innovation without compromising integrity.
“Technology can enhance quality, but accountability must stay human. This is why training and knowledge-sharing will remain essential if we want to safeguard our established integrity and ensure the safety, trust, and wellbeing of patients,” concluded Corinne Zaffarese Elbourne.
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