White Paper

Mitigating Risk Of Validated Analytical Procedure Failures When Upgrading Or Replacing LC Assets

By Pauline McGregor, Paula Hong, and Tran Pham

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In every high-performing lab, innovation drives product quality and efficacy and ultimately commercial success. In order to stay ahead, timely upgrade of existing LC instrumentation is key. While there are clear benefits to keeping technology like LC systems current, but there is often reluctance to purchase a new instrument or upgrade existing ones.

Some believe, falsely, that running a validated analytical procedure on a different model of LC system requires revalidation of the procedure and that regulatory pre-approval is necessary. The fact is, there is no current regulatory requirement that states this. For others, the reluctance may stem from past experiences or a reluctance to replace aging technology due to the time investment required to review and compare instrument specifications.

“How will this upgrade/purchase impact the performance of my validated analytical procedure?”

By applying key Quality by Design principles, this paper proposes a proactive and enhanced approach to help answer this question. Principles like instrument Quality by Design (iQbD) can help one understand the risks of validated analytical procedure performance when older workhorse LC instruments are replaced with newer instruments.

The process is independent of analytical procedures and focuses solely on instrument performance. iQbD consolidates key technical information from instrument specifications to identify and control instrument variables independent from other variables that may exist within an analytical procedure. iQbD helps to determine the suitability of new/upgraded instruments prior to purchasing and running validated analytical procedures. It mitigates the risk of problems with analytical procedures due to differences in instrumentation, allows proactive identification, and control of instrument differences, and ultimately, instills confidence that future problems, which may occur with the validated analytical procedure, are not due to switching to a new instrument.

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