In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.

He places Q11 in context with Q7 for API GMP, Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for the pharmaceutical quality system. The episode covers Section 3 on manufacturing process development, Section 5 on starting materials, and Section 6 on control strategy beyond release testing.

In the next episode, Subhi will cover ICH Q12.

Timestamps

00:00 ICH Q11 overview

00:47 Drug substance basics

01:14 Where Q11 fits in the ICH Quality framework

02:15 Section 3: Manufacturing process development

03:26 Linking drug substance quality to drug product quality

04:25 Section 5: Starting materials

05:41 Section 6: Control strategy

06:11 Wrap-up and next episode

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. He is a consultant, auditor, trainer, and speaker with experience across Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.