235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.

ICH Q8 defines the suggested contents for CTD Section 3.2.P.2 and aims to harmonize how pharmaceutical development is presented in regulatory submissions. It primarily applies to drug product development and later-stage submissions, where a full understanding of the product and process is expected.

The guideline is structured in three parts: the core sections, which outline development elements such as formulation, manufacturing, and container closure; the annexes, which introduce key Quality by Design concepts including QTPP, CQAs, risk assessment, design space, and control strategy; and a final section that explains how this information is organized across the CTD.

The episode walks through the relationship between TPP and QTPP, defines critical quality attributes, explains how design space is established through prior knowledge, risk assessment, and experimental work such as design of experiments, and outlines how a control strategy is built across materials, process controls, monitoring, and testing.

High Level QBD(4 min):

https://www.youtube.com/watch?v=orlPpfQvb5k

QBD vs. Design Controls: https://www.youtube.com/watch?v=W_LSD0kKQ34

00:00 Introduction to ICH Q8

00:42 Related QbD Videos

01:12 Structure of ICH Q8

02:28 Objective and Scope

04:49 Annexes and QbD Concepts

05:20 Quality Target Product Profile

06:33 Critical Quality Attributes

07:09 Design Space and DoE

09:17 Control Strategy

10:06 Submission and Wrap-Up

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.

A consultant, auditor, and trainer, Subhi has worked across companies including Baxter, Pfizer, and Gilead, supporting the development, manufacturing, and launch of medical devices and combination products for vaccines, generics, and biologics.