222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products.

Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management.

Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail.

In this episode, you will learn

What an ICH guideline is and how it differs from regulations and standards

Why guidelines still matter during inspections and enforcement

How ICH organizes its guidance into Q, S, E, and M categories

A high-level overview of the Quality Guidelines (Q1 through Q14), including:

Stability (Q1)

Analytical validation and development (Q2 and Q14)

Impurities (Q3)

Quality by Design and risk management (Q8 and Q9)

Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12)

Continuous manufacturing (Q13)

How different functional teams interact with different parts of the ICH framework

The next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability.

Timestamps

00:00 Introduction to the Series

00:48 Overview of ICH Guidelines

01:36 What an ICH Guideline Is and Is Not

03:04 The Four ICH Guideline Categories

04:08 Quality Guidelines Overview

08:46 Safety Guidelines Overview

09:28 Efficacy Guidelines Overview

10:33 Multidisciplinary Guidelines Overview

11:28 Wrap-Up and Next Steps

Subhi Saadeh is a Quality Professional and host of 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.