USP to Lead Development of Digital Quality Standards to Support Adoption and Regulatory Confidence

By expanding its digital offerings, USP will help quality specialists integrate quality standards into digital workflows with greater efficiency, consistency, and reduced risk

ROCKVILLE, MD, January 22, 2026 - The U.S. Pharmacopeia (USP) announced today the start of a major effort to expand its quality offerings through the development of digital reference standards (dRS) and digitally structured compendial methods (dDS) for digital-first workflows, with the goal of integrating these materials into the United States Pharmacopeia and the National Formulary (USP-NF). This initiative is intended to help manufacturers improve consistency and strengthen regulatory confidence through more transparent, standards-driven processes that reflect today's evolving manufacturing needs.

"Digital transformation is opening extraordinary opportunities for scientists, and USP is committed to ensuring standards keep pace with that innovation," said Ben Shapiro, Head of the Digital Standards Business Unit. "USP is working to deliver digital standards and solutions that help researchers and manufacturers work smarter, accelerate development, and expand patient access to trusted medicines. We're excited to partner with the scientific community to shape a future where digital tools and quality standards advance together."

The transformation to digital workflows requires a portfolio of new solutions, including methods, reference materials, and standard operating practices, that can support quality throughout drug development and manufacturing.

Building on this need for modernized tools, revisions to USP General Notices and General Chapter <11> effective December 2025 formally acknowledge that reference standards may be provided as either digital data or physical materials-a significant step in bringing dRS and dDS into the USP compendial framework. Regulatory uncertainty can pose a challenge to the early adoption of any major advancement in pharmaceutical process design and manufacturing. By working to establish compendial pathways for digital standards and methods, USP aims to bring confidence to manufacturers adapting emerging technologies.

As the pharmaceutical industry adopts AI, automation, and other emerging technologies, USP aims to provide the trusted foundation that manufacturers, developers, and regulators need to move forward with confidence, by evolving how USP's trusted standards integrate into digital environments.

"Behind every medicine is a team of scientists committed to getting it right for patients," explained Michael Levy, Senior Vice President, Digital & Innovation at USP. "Our mission is to give those teams digitally integrated standards and solutions that can help make their work faster and more reliable. By combining emerging technologies with USP's scientificrigor, we aim to support the people who safeguard quality every day-and help ensure that patients everywhere can access the medicines they depend on."

Advancing these efforts will require close collaboration across the manufacturing quality ecosystem to help ensure interoperability, transparency, and global alignment-critical elements for maintaining quality and trust in modern manufacturing.

USP's work on digital standards is part of a broader strategic effort to modernize how standards are developed and introduced. Through its emerging standards program-which now includes digital standards-USP is creating opportunities for manufacturers, developers, and regulators to provide feedback on potential standards in their initial development phases. This feedback-rich model enables USP to help test and refine solutions in real-world settings and create tools that can meet the evolving quality needs of industry without slowing innovation.

To learn more about USP's digital standards visit: https://www.usp.org/digital-standards.

+++

About USP

USP is a private scientific organization that collaborates with scientific experts and global stakeholders to develop science-based standards and solutions that help strengthen regulatory systems, simplify complex manufacturing supply chains, enhance supply reliability, and support adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in helping increase the availability of quality medicines, supplements and food ingredients for billions of people worldwide.

Media Contact: [email protected]