Joint IQ ALG/USP USP Workshop on Enhanced Approaches for Analytical Procedure Lifecycle
In 2018, IQ co-promoted a USP Workshop Promotion for Enhanced Approaches for Analytical Procedure Lifecycle held in Rockville MD (Sep 2018) and hosted by the USP Validation and Verification Expert Panel. This workshop was the third in a series sponsored by USP on the topic involving enhanced approaches to analytical method lifecycle development. Previous workshops included the “Lifecycle Approach to Validation of Analytical Procedures with Related Statistical Tools Workshop” (Dec 2014, Rockville MD) and the “Workshop on Lifecycle Approach of Analytical Procedures” (Nov 2016, Prague, Czech Republic). This third workshop continued to advance discussion surrounding ICH Q8 lifecycle concepts to analytical methods. It included three breakout sessions on (a) procedure understanding and control strategy, (b) development of an ATP, and (c) procedure qualification. The workshop included organizational updates from EFPIA, BP, USP, and FDA representatives surrounding this topic. Finally, the workshop highlighted several presentations that included case study examples for practical implementation of analytical method lifecycle concepts: Method Lifecycle: From Development to Qualification by Antonio Ramos (Hovione), Analytical Method Lifecycle: Current Status and Opportunities by Phil Borman (GSK), Define & Qualify – Tools for Enhanced Analytical Procedure Development by Brent Harrington (Pfizer), and Analytical Method Lifecycle for Impurity Methodology: Some Strategies and Examples by Mark Argentine (Eli Lilly).
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