234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7.

Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters in practice.

Covers:

• Scope and where GMP begins

• API starting material (core concept)

• GMP scaling across the process (Table 1)

• Quality unit and QMS expectations

• Production and in-process controls

• Validation and change control

• CMOs and supply chain

• Clinical trial flexibility (Section 19)

Timestamps

00:00 Intro

00:13 What Q7 Covers

01:23 Scope and GMP Start

02:19 API Starting Material

04:05 GMP Scaling (Table 1)

05:30 Quality and QMS

06:58 Production Controls

08:26 Validation

09:46 Change Control

10:27 CMOs / Supply Chain

12:11 Clinical

13:12 Takeaways

https://database.ich.org/sites/default/files/Q7%20Guideline.pdf

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 companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.