CPHI Milan 2026: Digital Supply Chains

The pharmaceutical supply chain is an intricate and complex system where one mistake in the manufacture of a critical drug could impact the lives of hundreds, if not thousands of people, if a shortage in that supply is the result of that mistake. Active ingredients, excipients, final drug products, packaging, and shipping are all part of the supply chain ecosystem, and regulators and standard setting organizations play a significant role in keeping that system healthy.

Drug shortages can result not just from manufacturing failures but also from natural disasters, geopolitical pressures, and policy changes. In June 2026, the US Pharmacopeia (USP) published its annual drug shortages report, which stated that while drug shortages are lasting longer, the total number of shortages decreased by 23% in 2025.^1,2 USP also found that product discontinuation was higher, with a 60% increase from 2024 to 2025.

To help mitigate drug shortages, Michael Levy, senior vice president, Digital & Innovation, USP, believes that quality control labs need machine-readable, science-based digital standards to modernize workflows without weakening the rigor that underpins patient safety.³

According to Levy, digital standards cut manual handoffs, rework, and ambiguity by building quality requirements directly into laboratory information management systems, electronic lab notebooks, and regulatory platforms. Electronic capture with version control also strengthens data integrity and auditability across a method's lifecycle.³

To find out more about artificial intelligence (AI) and the digitalization of supply chain security, PharmTech spoke with Levy about his upcoming panel presentation on October 6, The Next Phase of Pharma Supply Chains, at CPHI Milan, which is occurring from October 6-8.

PharmTech: What's the practical difference between a digital supply chain and an AI-powered one?

Levy: In pharmaceutical supply chains and manufacturing, digital workflows empower the humans doing the work. Digitalization helps lab workers seamlessly connect machine-readable data and methods, scaling and modernizing operations without sacrificing quality. AI can provide a decision-support function, with scientists retaining judgment and control over the process.

Regulatory compliance, geopolitical risk, and sustainability are different kinds of pressure. Does AI address them in fundamentally different ways, or is there a common thread in how these systems help companies manage all 3?

AI applications can differ, but there is a common thread in using data to improve visibility and support more informed decision-making across the supply chain. Developers, manufacturers, and regulators are collaborating to shape a global framework that prioritizes consistency, transparency, and trust. As the industry adopts AI, digitalization, and advanced manufacturing technologies, safeguarding patients’ access to quality medicines should remain at the core of every decision.

What's the biggest misconception pharmaceutical companies have about AI adoption in supply chain management, and what tends to trip them up in practice?

Technology alone is not the solution to digitalization. Scaling new technology while ensuring quality requires consistent, trusted standards that can be applied across platforms and organizations. Digital standards can provide shared, trusted building blocks, encouraging collaboration among method developers, manufacturers, technology providers, and regulators to build that trust. Collaborative development helps ensure that emerging digital standards are practical, fit for purpose, and aligned with regulatory expectations.

What roles do standards organizations like USP play in supply chain management?

At USP, we’re modernizing compendial standards to help solve industry pain points. By embedding digital standards and methods into our compendial framework, USP helps teams work faster and more reliably so patients get the medicines they depend on. Our latest solutions include USP MethodConnect, a machine-readable library based on verified United States Pharmacopeia–National Formulary test methods designed for use in digital laboratory systems, and USP-ID, which streamlines nuclear magnetic resonance analysis.

References

1. USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk
2. USP. 2025 USP Annual Drug Shortages Report. US Pharmacopeia. June 2026.
3. Levy M. Digital standards aim to modernize quality qssurance without compromising confidence. PharmTech Quality and Regulations eBook 2026. June 15, 2026. https://www.pharmtech.com/view/digital-standards-aim-to-modernize-quality-assurance-without-compromising-confidence

USP will be at booth #16F30 at CPHI Milan.

About the Speaker

Mike Levy is senior vice president, Digital & Innovation at US Pharmacopeia (USP). USP works with scientific experts and global stakeholders to develop science-based standards and solutions that help strengthen regulatory systems, simplify manufacturing supply chains, enhance supply reliability, and support innovation. Used in over 150 countries, USP standards and solutions help increase the availability of quality medicines, supplements, and food ingredients worldwide.