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HPLC – 52nd International Symposium on High Performance Liquid Phase Separations

Poster Presentation

Practical Implementation of ICH Q14 Guidelines in Digital Method Development

Tuesday, July 23rd, 2024

10:00 - 11:00 AM

Room: Colorado A-F

Anne Marie Smith; Product Manager, Mass Spectrometry and Chromatography; ACD/Labs

Authors: AM. Smitha, I.Oshchepkovaa

[a] Advanced Chemistry Development, Inc, 8 King St E, Toronto, ON, M5C 1B5, Canada

The International Council for Harmonization has developed the ICH Q14 guidelines, a scientific and risk-based approach to analytical procedure development. These guidelines provide a systematic framework for developing analytical procedures to ensure their robustness and appropriateness for the intended use. The aims of the guidelines include expediting approvals, reducing redundancies, and minimizing post-approval changes of analytical procedures. Implementation of these principles minimizes effort across the analytical procedure life cycle while increasing the understanding and confidence in procedure performance. The guidelines highlight two approaches—minimal and enhanced. The analytical procedure lifecycle encompasses various elements and how they are linked.

ACD/Labs’ method development software, AutoChrom® supports the implementation of elements of the ICH Q14 guidelines. Tools and features within the software align with elements of the analytical procedure lifecycle including prior knowledge, technology selection, and analytical procedure development.

Here, we focus specifically on elements within analytical procedure development to demonstrate how ACD/Labs’ AutoChrom software aligns with the ICH Q14 guidelines, facilitating the development of robust and appropriate analytical procedures, while enhancing efficiency and minimizing risks throughout the analytical procedure lifecycle.

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