USP Proposal on Analytical Procedure Lifecycles

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] USP has published a “stimuli article” proposing a new general chapter (<1220>) on the “analytical procedure lifecycle.” The article describes the current thinking of the USP Validation and Verification Expert Panel regarding future trends in analytical procedure development, qualification, and continued monitoring. This “enhanced approach” potentially offers several advantages, the article states, including: ● improved understanding of the procedure and control of sources of variability ● procedures that are more robust, resulting in fewer failures during use and during qualification in a new laboratory ● reduction of overall resources required for a new or revised procedure, ie. levels of effort, formality, and documentation should be commensurate with the level of risk, and ● identification of adverse trends, allowing proactive measures and facilitation of continued improvements and change control through continued monitoring. Comments will be accepted until March 31, 2017. [For more on the issues around the analytical method lifecycle and USP’s engagement with them, see IPQ December 26, 2014.]
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