241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

What this episode covers

Subhi Saadeh, Founder of Let's Combinate, explains the core concepts of ICH Q14, focusing on the shift from traditional validation to a science- and risk-based analytical procedure lifecycle. He details how the Analytical Target Profile (ATP) defines method requirements and drives technology selection, risk assessment, and development before formal validation under ICH Q2. Saadeh highlights the connection between ICH Q14 and ICH Q12, emphasizing that robust lifecycle management and prior knowledge facilitate flexible change management for established conditions.