In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions.

The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3.

ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelines

ICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdf

Timestamps

00:00 Introduction to the ICHQ Series

00:03 What Pharmacopeial Harmonization Means

00:42 Why ICH Q4 Exists

01:55 ICH Q4 Framework and Structure

02:54 Understanding Q4A, Q4B, and the Annexes

03:59 Practical Examples (Particulates, Disintegration)

08:05 Conclusion and Next Steps

Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions