ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1)
In this episode of Let’s ComBinate, Subhi continues the ICH Q-series with ICH Q6 and explains why specifications are central to defining and controlling drug products and drug-device combination products.
All of which come together to support the release decision.
He also covers the difference between ICH Q6A (small molecules) and ICH Q6B (biologics), highlighting the increased variability in biologics and the greater reliance on characterization and process understanding.
Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains.
Key Topics
- what to test (attributes or CQAs tied to safety and efficacy)
- how to test (methods and procedures)
- what is acceptable (acceptance criteria or limits)
- alignment of shared principles across Q6A and Q6B
- expanded scope to include new modalities and combination products
- linkage to ICH Q12 lifecycle management and established conditions
- a shift toward more science and risk based approaches with less reliance on routine batch testing
Timestamps
- 00:00 Intro to ICH Q6
- 00:36 Host background
- 01:05 Why specifications matter
- 01:49 Q6A vs Q6B overview
- 02:33 Purpose of ICH Q6
- 02:59 What is a specification
- 04:27 Q6 R1 update themes
- 05:49 Lifecycle and risk based specifications
- 06:29 Wrap up and next steps
