USP Develops Digital Quality Standards for Global Pharmaceutical Manufacturing

The US Pharmacopeia (USP) has initiated a significant effort to develop digital reference standards (dRS) and digitally structured compendial methods (dDS) designed for digital-first workflows (1). This transition is designed to provide tools that integrate more efficiently into modern digital environments, strengthening regulatory confidence through transparent, standards-driven processes. These materials are being developed for integration into the United States Pharmacopeia and the National Formulary (USP-NF) to help manufacturers maintain consistency while meeting evolving quality requirements.

How will digital standards influence regulatory pathways and process design?

The transition to digital workflows necessitates a new portfolio of solutions, including standard operating practices and updated methods, to support quality across the entire drug development lifecycle. Because regulatory uncertainty can often hinder the early adoption of emerging technologies, USP is establishing compendial pathways to bring confidence to manufacturers who are adapting their processes. Significant progress was made in December 2025 when revisions to USP General Notices and General Chapter 11 formally acknowledged that reference standards could be provided as digital data instead of solely as physical materials. As the industry continues to adopt automation and AI, these digitally integrated standards provide a foundation for both developers and regulators to move forward reliably.

Michael Levy, SVP, Digital & Innovation at USP commented in a USP press release that “Behind every medicine is a team of scientists committed to getting it right for patients. 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” (1). As standards rapidly develop with emerging techniques and technologies, the USP’s dRS and dDS are intended to keep drug producers in the loop about new methods and increase productivity of pharmaceutical firms globally.

Why is industry collaboration essential for the success of digital-first standards?

Maintaining trust and quality in modern manufacturing requires a high degree of interoperability and global alignment. To achieve this, USP is utilizing its emerging standards program to allow manufacturers, developers, and regulators to offer feedback during the initial phases of standard development. This model enables the testing and refinement of digital solutions in real-world settings, ensuring the final tools meet industry needs without slowing the pace of innovation (1). As a private scientific organization that collaborates with experts across 150 countries, USP aims to simplify complex supply chains and enhance the availability of quality medicines globally.

Ben Shapiro, head of the Digital Standards Business Unit, stated in a USP press release, “Digital transformation is opening extraordinary opportunities for scientists, and USP is committed to ensuring standards keep pace with that innovation. 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.”

How will these developments affect quality testing across the industry?

The push for digital-first workflows and integrated solutions is particularly relevant as the pharmaceutical industry tackles the manufacturing of increasingly complex products, such as glucagon-like peptide-1 receptor agonists. These medicines require rigorous quality assurance testing to identify and control both product and process-related impurities, a task that is often time-consuming and challenging. In response to unprecedented patient demand for these treatments, USP has introduced dedicated solutions, including well-characterized analytical reference materials and detailed information sheets to ensure the purity of these products and the accuracy of test methods (2).

These resources are designed to complement existing USP-NF standards, specifically general chapters 1503 and 1504, which outline quality attributes for peptide drug substances and starting materials. By establishing these scientific foundations, USP provides manufacturers with the tools necessary for process development and validation activities, especially for those producing generic versions of these complex therapeutics (2). Through ongoing engagement with industry and regulatory stakeholders, USP aims to identify priority challenges and deliver solutions that enhance regulatory clarity and product quality across the global supply chain.

References:

1. USP. USP to Lead Development of Digital Quality Standards to Support Adoption and Regulatory Confidence. Press Release. Jan 22, 2026.
2. USP. USP Launches Resources to Support Product Quality for Agonists. Press Release. Oct 25, 2025.