Hardware Podcasts

222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series

Let's Combinate · 14 Jan 2026 · 12m

What this episode covers

Subhi Saadeh, founder of Let's Combinate BioWorks and host of the Let's Combinate podcast, provides a high-level orientation to the International Council for Harmonisation (ICH) guidelines, explaining their organization into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) families. She emphasizes that while ICH guidelines are not regulations, they form the practical backbone of regulatory expectations for drug and drug-device combination products, particularly regarding stability, analytical validation, and quality systems. The episode details the specific scope of the 14 active Quality guidelines (Q1–Q14) and briefly outlines the roles of the S, E, and M series in the broader product lifecycle.

Most relevant to

established companies

Topics

Mentioned

Companies
International Council for Harmonisation, FDA, Let's Combinate BioWorks, Combination Products Coalition, AAMI
Also
ASTM Committee E55, ICH Q1, ICH Q2, ICH Q3, ICH Q4, ICH Q5, ICH Q6, ICH Q7, ICH Q8, ICH Q9, ICH Q10, ICH Q11, ICH Q12, ICH Q13, ICH Q14

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