Key Takeaways:
· The U.S. Pharmacopeia (USP) announces a major new effort to modernize how pharmaceutical quality standards are delivered.
· By creating clear compendial pathways for digital standards and methods, USP hopes to reduce uncertainty and help manufacturers adopt emerging technologies with greater confidence.
· Enhanced clarity in integrating standards into digital environments reduces knowledge gaps and uncertainty, accelerating digital transformation while ensuring quality and consistency in innovative manufacturing processes.
The U.S. Pharmacopeia (USP) is an independent, non-profit organization that establishes public quality standards for medicines, dietary supplements, and food ingredients to ensure identity, strength, quality, and purity. Its standards, published in the USP–NF, are recognized by the FDA and used worldwide.
The organization announces a major new effort to modernize how pharmaceutical quality standards are delivered by developing digital reference standards (dRS) and digitally structured compendial methods (dDS) that are designed for “digital-first” workflows. USP’s goal is to eventually include these digital tools in the official United States Pharmacopeia and National Formulary (USP–NF).
This initiative is meant to help drug manufacturers improve consistency, strengthen quality, and build greater confidence with regulators by using clearer, more transparent, standards-based processes that match today’s changing manufacturing environment.
“Digital transformation is opening extraordinary opportunities for scientists, and USP is committed to ensuring standards keep pace with that innovation,” says Ben Shapiro, Head of the Digital Standards Business Unit. “We’re excited to partner with the scientific community to shape a future where digital tools and quality standards advance together.”
The shift toward digital workflows in drug development and manufacturing requires new solutions beyond traditional paper-based methods. This includes updated reference materials, modernized testing methods, and standard operating practices that can support quality throughout the entire lifecycle of a medicine.
A key step forward is that revisions to USP’s General Notices and General Chapter <11>, effective in December 2025, will formally recognize that reference standards may be provided not only as physical materials but also as digital data. This is an important milestone for bringing digital standards into the official compendial framework.
USP also noted that regulatory uncertainty can slow the adoption of new manufacturing approaches. By creating clear compendial pathways for digital standards and methods, USP hopes to reduce uncertainty and help manufacturers adopt emerging technologies with greater confidence.
As the pharmaceutical industry increasingly uses AI, automation, and other advanced tools, USP aims to provide a trusted foundation that supports both innovation and quality.
“Behind every medicine is a team of scientists committed to getting it right for patients,” explains 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 scientific rigor, 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 digital standards will require close collaboration across manufacturers, regulators, and the broader quality ecosystem to ensure interoperability, transparency, and global alignment. I reached out to Ben Shapiro at USP to ask about this collaboration, the validation process, expected timeline, and global response to these digital standards. He filled me in on all of it.
HCP: How will digital reference standards and digitally structured methods be validated and governed to ensure they deliver the same level of trust and reproducibility as traditional physical standards?
Shapiro: USP’s Digital Standards will follow the same process that all USP Standards undergo to ensure quality, rigor, and practicality. This standard process includes laboratory testing, expert balloting, and stakeholder feedback.
In addition, Digital Reference Standards (dRS), which are digital datasets suitable for use as articles of comparison, will establish traceability to an authentic USP Reference Standard Material. Digital Documentary Standards (dDS), structured USP test methods suitable for integration with an Electronic Lab Notebook (ELN) or Laboratory Execution System (LES), will establish traceability to USP’s established documentary standards.
HCP: How do you anticipate regulators globally responding to compendial digital standards, and is USP working with international agencies to support alignment beyond the U.S.?
Shapiro: Regulators and stakeholders across the global pharmaceutical manufacturing industry have acknowledged the increased digitization, which has accelerated the urgency for quality standards to support more effective digital workflows.
Through conversations with manufacturers and regulators, we’ve learned that uncertainty is the primary barrier to adopting digital standards. Manufacturers worry about potential delays in product development and delivery because regulators don’t yet understand or accept digital standards in the regulatory approval process. Yet regulators are open to change and recognize the immense potential of digitalization and digital tools, which digital standards can support.
HCP: What is the expected timeline for integrating dRS and dDS into USP–NF, and will there be pilot programs or early adopters involved before broader implementation?
Shapiro: USP is actively seeking collaborators for a pilot program to ensure Digital Standards are fit-for-purpose and practical to implement. We are working with a diverse coalition of stakeholders on this topic to shape digital standards and the future of quality medicines.
USP also recently launched an Emerging Standards program to facilitate earlier engagement and collaboration on proposed standards, ahead of standard introduction via the Pharmacopeial Forum (PF). We plan to publish initial digital standards in this Emerging Standards program imminently.
This work builds on USP’s previous and ongoing efforts to advance digitalization for medicine quality. The first step to integrating dRS and dDS into USP-NF was the revisions to USP General Notices and General Chapter <11>, which formally acknowledge that reference standards may be provided as either digital data or physical materials. These revisions became effective in December 2025 and established a foundation for scientifically rigorous, traceable, and regulatory-aligned standards.
HCP: For manufacturers already investing in AI-driven or automated quality systems, how will USP’s digital standards practically integrate with existing digital infrastructure and workflows?
Shapiro: USP is committed to delivering solutions into existing digital ecosystems, such as Electronic Lab Notebooks (ELN), Laboratory Execution Systems (LES), Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and others. We strongly believe in the need for FAIR (Findable, Accessible, Interoperable, and Reusable) and common data standards to create stronger connections between digital systems. USP is a member of the Allotrope Foundation, which pioneers work in this area.
According to research from 2024, only 10% of labs have progressed beyond the pilot phase of their lab modernization and digitalization journey. Many laboratories and quality assurance teams continue to evaluate laboratory informatics systems to digitize workflows, automate data capture, and link quality systems. Digital tools like nuclear magnetic resonance (NMR) spectroscopy, advanced analytics, and AI are accelerating medicine development and manufacturing. But the absence of clear, science-based standards risks fragmentation, delays, and patient safety concerns.
The development of digital standards is intended to address this gap in quality frameworks for digital workflows. By evolving USP’s trusted standards into machine-readable, digitally structured formats, we’re helping scientists benefit from seamless integration, validation, and traceability of digitalization efforts for modern manufacturing systems, data flows, and regulatory submissions across evolving and existing workstreams. We do not believe in creating redundant middleware for already overstretched IT departments.
To learn more about USP’s digital standards visit: https://www.usp.org/digital-standards.
