From Electronic Document to Executable Method: U.S. Pharmacopeia (USP) Journey to Digitalizing the USP NF

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A Recap from the 2024 Allotrope Connect Workshop: Advancing Digital Method Execution with USP

At the 2024 Allotrope Connect Workshop, ZONTAL and U.S. Pharmacopeia (USP) presented a shared session on the transformation of laboratory method execution through digital innovation. Featuring Christof Gaenzler of ZONTAL and Kyle Larsen of USP, the session highlighted the collaborative work between ZONTAL, USP, and the Pistoia Alliance to digitize compendial methods for seamless and standardized laboratory workflows.

Key Takeaways from the Workshop

Addressing the Challenges in Analytical Method Transfer

Transferring analytical methods between laboratories, instruments, and organizations has traditionally been a manual and error-prone process. Variability in instrument settings, lack of method standardization, and undocumented parameters can all contribute to inconsistent results and increased troubleshooting efforts.

These inefficiencies not only impact reproducibility but also present significant regulatory compliance challenges. Documentation, validation, and audit-readiness require extensive manual tracking, slowing down workflows and increasing operational costs.

How ZONTAL and USP Enable Digital Method Execution

ZONTAL and USP are advancing digital method execution by leveraging FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. Central to this effort is the Methods Hub, an initiative from the Pistoia Alliance that acts as a centralized repository for standardized digital methods.

In this model, methods are digitized and stored in the Methods Hub, where ZONTAL translates and standardizes the parameters. These digital methods are then transferred directly to Chromatography Data Systems (CDS), eliminating the need for manual configuration.

As methods are executed, data is automatically captured and stored with full traceability. Any modifications made during execution are logged to ensure auditability and regulatory compliance. This digital process significantly reduces variability, enhances reproducibility, and supports seamless integration across laboratory systems.

USP’s Role in Digital Method Standardization

USP is building on the foundation laid by Merck, GSK, and ZONTAL by converting regulatory monographs into structured digital formats. This initiative from USP’s Digital and Innovation Team aims to reduce manual transcription efforts, enable automated integration into laboratory systems, and promote real-time regulatory compliance.

During the session, a live demonstration showcased how a USP monograph was successfully transformed into a digitally executable format. The method was then integrated into a CDS without manual intervention, demonstrating how digitized methods can streamline laboratory workflows and improve data integrity.

The Future of Digital Method Execution

Digital method execution is reshaping laboratory operations by automating and standardizing method transfers. This shift results in more reproducible results, improved regulatory compliance, and enhanced data integrity. The application of FAIR principles ensures that digital methods remain accessible, traceable, and interoperable across platforms.

As laboratories move toward fully digital and automated workflows, the collaboration between ZONTAL, USP, and the Pistoia Alliance stands as a leading example of how digital innovation can simplify complex processes while maintaining scientific rigor.