The US Pharmacopeia (USP) has announced the launch of a programme to develop digital reference standards and digitally structured compendial methods intended for use in digital-first pharmaceutical development and manufacturing environments.
“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,” said Michael Levy, Senior VP of Digital and Innovation at USP.
USP said regulatory uncertainty can slow the adoption of new manufacturing approaches, and that having digital standards could help address this challenge.
The digital standards will be designed to support the integration of quality standards into digital workflows and, over time, into the US Pharmacopeia–National Formulary (USP–NF).
USP said the work is intended to improve consistency and support regulatory confidence as manufacturers adopt automation, data-driven systems and advanced digital tools.
According to USP, the move reflects increasing industry adoption of digital laboratory systems, automated manufacturing platforms and emerging technologies such as artificial intelligence, which require standards that can be applied in structured, machine-readable formats.
Standards established through public process
Revisions to USP General Notices and General Chapter <11> became effective December 2025, formally recognising that reference standards may be provided as either physical materials or digital data.
USP said this change establishes a compendial basis for the future use of digital reference standards and methods.
The digital standards initiative forms part of USP’s broader emerging standards programme, which allows manufacturers, developers and regulators to provide feedback on standards during early development.
USP said this approach is intended to support real-world testing and alignment with current manufacturing practices.
USP added that collaboration across the pharmaceutical quality ecosystem will be required to support interoperability, transparency and global alignment as digitalisation of manufacturing continues.
The development process of the standards will involve industry collaboration and feedback, suggesting it will be gradual and iterative.