Episode
235 - ICH Q8: How Pharmaceutical Development Actually Works
- Published
- Apr 22, 2026
- Duration seconds
- 649
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Summary
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, deve…