Hardware Podcasts

233 - Most Teams Misunderstand Specifications | ICH Q6

Let's Combinate · 8 Apr 2026 · 6m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate and former member of the ICH Q6(R1) subteam, explains the critical role of specifications in defining and controlling drug products and drug-device combination products. He breaks down the three core components of a specification—attributes (CQAs), methods, and acceptance criteria—and distinguishes between ICH Q6A for small molecules and Q6B for biologics. Saadeh highlights key themes from the 2024 ICH Q6(R1) concept paper, including the alignment of principles across Q6A and Q6B, the expansion of scope to include new modalities like gene therapies, and the shift toward science- and risk-based lifecycle management linked to ICH Q12.

Most relevant to

established companies

Topics

Mentioned

Companies
Let’s Combinate
Tools
HPLC
Also
ICH Q6, ICH Q6A, ICH Q6B, ICH Q12

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