Having certified reference standards is critical to maintaining the quality and safety of pharmaceutical products. As technology has advanced, the world of drug development and drug manufacturing is rapidly becoming more digital. This shift has increased the need for digital standards that support these modern workflows while protecting the quality, safety, and effectiveness of medicines.
To learn more about digital standards and how they are being developed, we talked with Ben Shapiro, director of digital standards at US Pharmacopeia (USP), an independent, scientific nonprofit organization.
Q: What are digital standards and how do they differ from traditional physical reference standards?
A: The term digital standards can be used to describe both digital reference standards (dRS) and digital documentary standards (dDS) used for the quality testing of medicines. The first, dRS, are digital datasets intended to serve as digitally structured versions of USP reference standard materials, with qualities that support their use as references for comparison in medicine quality testing. Similarly, dDS allows integration of USP-NF monograph and general chapter method-guidance written content into digital platforms already in use by stakeholders in digitized lab environments and helps guide adoption of technologies like artificial intelligence (AI).
Digital standards follow the same development and review process as all other standards available through USP, ensuring validity, expert and stakeholder input, and practicality. Both dDS and dRS are machine-readable, validated quality testing methods, and reference data that will help power advanced laboratory workflows and facilitate standards integration.
USP’s digital standards offer manufacturers and other stakeholders the same science-based rigor and regulatory confidence as traditional USP standards, but will allow for more seamless integration into digital workflows through scalability and interoperability of new technologies across platforms.
Q: Why is USP undertaking this initiative now? What changes in the pharmaceutical industry have you seen that make this evolution necessary?
A: It’s widely recognized that the world is becoming increasingly digital, and regulated industries like pharmaceutical manufacturing are no exception. As digital transformation accelerates, there is a growing need from industry to establish quality standards that can help teams build and manage effective digital workflows that continue to center around quality.
One way that USP is supporting digital innovation is by launching a framework to transform medicine quality standards into interoperable digital components of the healthcare ecosystem. This framework will help make USP quality standards more accessible and enable manufacturers to continue developing and delivering quality medicines.
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Advancing these efforts requires ongoing collaboration across the pharmaceutical industry beyond the work USP is doing—to increase our understanding of real-world issues that manufacturers are facing and ensure both trust and confidence in digital workflows in this evolving landscape.
Q: How will these digital standards integrate into modern laboratory and manufacturing workflows, particularly in digital or automated environments?
A: Many laboratories and quality assurance teams are adopting laboratory informatics systems, such as electronic lab notebooks, laboratory execution systems, laboratory information management systems, and chromatography data systems, to digitize workflows, automate data capture, and connect quality systems across the organization. Alongside these platforms, emerging digital tools like nuclear magnetic resonance, advanced analytics, and AI are increasingly embedded into laboratory and manufacturing environments, transforming how scientists and quality professionals work by improving speed, transparency, and confidence.
At USP, we envision direct integration of digital standards into digital and automated systems to provide a consistent foundation of high‑quality processes in today’s laboratory environments. USP’s standards can help manufacturers advance digitization without compromising quality, reducing the risk of fragmentation, inefficiencies, and potentially harmful impacts on patient safety.
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Q: For those facing resource constraints, how are digital standards designed to guide and support digital transformation without creating additional barriers to maintaining quality?
A: We recognize that broad adoption of digital standards is dependent on reducing regulatory uncertainty and fostering collaboration across the pharmaceutical industry among innovators, manufacturers, regulators, and more. In fact, we are currently seeking collaborators for a USP pilot program to ensure digital standards are relevant and practical to adopt. We also launched the Emerging Standards program to encourage engagement from stakeholders earlier in the standards development process, and we plan to include digital standards in this program.
By creating opportunities for manufacturers, developers, and regulators to engage early, test new approaches, and provide real-world feedback before standards become compendial requirements, USP can help de-risk adoption, support innovation, and ensure digital standards align with industry member needs.
Q: Can you explain the significance of recent revisions to USP General Notices and General Chapter <11> regarding digital reference standards and how they enable or change compendial compliance? Why is it important that digital reference standards and test methods are formally recognized within the USP compendial framework?
A: A major milestone in USP’s digital standards evolution occurred in December 2025, when revisions to USP–NF General Chapter <11> USP Reference Standards and related General Notices formally recognized the use of dRS and digital test methods in compendial testing.
By explicitly acknowledging these tools within the compendial framework, USP’s revisions establish a clear foundation for traceability, data integrity, and scientific rigor in digital and automated laboratory environments. This clarity enables manufacturers to more confidently incorporate digital tools into compendial workflows without creating new regulatory barriers.
Q: Why is collaboration with industry critical to ensuring digital standards and tools are aligned with the technologies manufacturers are already using? How is USP collaborating with industry stakeholders, regulators, and technology providers to ensure these digital standards are interoperable, practical, and globally relevant?
A: Collaboration with a diverse group of stakeholders, including regulators, is essential to accelerating progress and helping to ensure that digital standards and other tools are relevant, address real challenges, and work with the technological advancements manufacturers have already adopted in recent years or are currently implementing.
In ongoing conversations with manufacturers and regulators, USP has learned that uncertainty, rather than opposition, is the primary barrier to adoption of digital technologies. Manufacturers remain cautious about incorporating digital standards into regulatory submissions due to concerns about potential delays or confusion from regulators, which could impact development timelines or approvals, and patients’ ability to access quality medicines.
Yet regulators have acknowledged the potential of digitization to strengthen quality, efficiency, and data integrity. While there is a somewhat common perception that regulators are resistant to change, our conversations reflect a shared interest in future-ready solutions that can be implemented by stakeholders across the landscape.
