Hardware Podcasts

224 - ICH Q2 Explained: What Analytical Validation Really Requires

Let's Combinate · 28 Jan 2026 · 10m

What this episode covers

Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q2 guideline for analytical procedure validation, emphasizing its role in harmonizing global regulatory expectations for drug substance, drug product, and the drug element of combination products. He details core validation characteristics including accuracy, precision, specificity, linearity, range, LOD, and LOQ, and clarifies the lifecycle relationship between ICH Q2 (validation) and ICH Q14 (development). Saadeh highlights a regulatory gap where device performance testing lacks equivalent ICH standards, noting that companies must distinguish between drug analytical methods and device mechanical testing. He provides practical guidance on efficiently reading the 38-page guideline and applying its framework to avoid rework and delays in regulatory submissions.

Most relevant to

early-stage companies

Topics

Mentioned

Also
ICH Q2, ICH Q14, Combination Products Coalition, ASTM Committee E55, AAMI

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