LCGC Article on Analytical Procedure Lifecycle Approaches

An article titled "Analytical Procedure Lifecycle Approaches in Accordance with ICH Q14 and ICH Q2(R2): Opportunity Knocks, or Just Another Challenge and Headache? Part 1" was published in LCGC International (April 2026, Volume 3, Issue 3, pages 24–28). It explains how ICH Q14 and the revised ICH Q2(R2), officially adopted in November 2023, are accelerating a fundamental shift in analytical sciences: away from viewing validation as a one-time activity and toward managing analytical procedures through a structured lifecycle focused on sustained fitness for purpose.

The article is authored by Amanda Guiraldelli Mahr, Jean-Marc Roussel, and Luis Flores Ortiz. It highlights key emerging aspects and practical opportunities associated with implementing lifecycle thinking, including the use of science- and risk-based approaches aligned with USP’s lifecycle concepts (notably General Chapter <1220>).

A central theme is the Analytical Target Profile (ATP), presented as the cornerstone of the lifecycle approach described in ICH Q14. By translating product requirements into clear, measurable analytical performance criteria, the ATP provides a consistent, technology-independent benchmark that can guide method development, validation strategy, and change management across the procedure’s lifetime.

The article is available on the LCGC International website.

Amanda Guiraldelli Mahr, who is also a Board Member of the ECA Analytical Quality Control Group (AQCG), will give further insights into the topic, together with Dr Joachim Ermer and Patrick Jackson at the ECA event "The Analytical Procedure Lifecycle" (17-18 November 2026, Heidelberg, Germany). The Analytical Procedure Lifecycle will also be one topic at PharmaLab 2026.