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

Table of Contents

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 focused on the collaborative efforts between ZONTAL, USP, and the Pistoia Alliance to digitize compendial methods for seamless and standardized laboratory workflows.

Addressing the Challenges in Analytical Method Transfer

The process of transferring analytical methods between laboratories, instruments, and organizations has historically been manual, time-consuming, and prone to errors. Variations in equipment settings, lack of standardization, and hidden parameters often result in inconsistent results and increased troubleshooting efforts.

Key Challenges in Analytical Method Transfer:

Hidden instrument settings create variability in results.
Manual configuration errors impact method reproducibility.
Regulatory compliance challenges require extensive documentation and validation.
Extended troubleshooting times slow down workflows and increase costs.

How ZONTAL and USP Enable Digital Method Execution

By leveraging FAIR (Findable, Accessible, Interoperable, and Reusable) data principles, ZONTAL and USP are enabling seamless method standardization and execution across laboratory environments. The Methods Hub, a Pistoia Alliance initiative, serves as a centralized repository for digital methods, ensuring interoperability and reproducibility across different software platforms and laboratory systems.

How It Works:

Methods are digitized and stored in the Methods Hub.
ZONTAL translates and standardizes method parameters.
Digital methods are transferred to Chromatography Data Systems (CDS) without requiring manual input.
Data from executed methods is automatically collected and stored, ensuring full traceability.
Modifications made during execution are logged for compliance and audit purposes.

USP’s Role in Digital Method Standardization

Expanding on the collaborative work of Merck, GSK, and ZONTAL, USP’s Digital and Innovation Team is advancing digital method standardization by converting regulatory monographs into structured digital formats. This initiative aims to:

Enable automatic integration of USP content into laboratory systems.
Reduce manual transcription efforts by directly importing structured methods.
Ensure real-time compliance with regulatory standards.

A live demonstration during the session showcased the successful conversion of a USP monograph method into a digitally executable format, illustrating seamless integration into a Chromatography Data System (CDS) without manual intervention.

The Future of Digital Method Execution

The adoption of digital method execution is rapidly transforming laboratory workflows. By automating and standardizing method transfer, the industry benefits from:

Reduced inconsistencies and improved reproducibility.
Enhanced regulatory compliance and data integrity.
FAIR data principles ensuring long-term accessibility and interoperability.

As laboratories embrace automated, data-driven workflows, ZONTAL and USP remain committed to supporting organizations in their transition to a fully digital future.