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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-01-14
- Length: 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-14-222-how-ich-guidelines-are-organized-understanding-the-q-s-e-and-m-series
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/222---How-ICH-Guidelines-Are-Organized-Understanding-the-Q--S--E--and-M-Series-e3diqfk

## Summary

Subhi Saadeh, founder of Let's Combinate BioWorks and host of the Let's Combinate podcast, provides a high-level orientation to the International Council for Harmonisation (ICH) guidelines, explaining their organization into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) families. She emphasizes that while ICH guidelines are not regulations, they form the practical backbone of regulatory expectations for drug and drug-device combination products, particularly regarding stability, analytical validation, and quality systems. The episode details the specific scope of the 14 active Quality guidelines (Q1–Q14) and briefly outlines the roles of the S, E, and M series in the broader product lifecycle.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-14-222-how-ich-guidelines-are-organized-understanding-the-q-s-e-and-m-series#t=0) Introduction: Subhi Saadeh and the ICH Series

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- International Council for Harmonisation (company)
- FDA (company)
- Let's Combinate BioWorks (company)
- Combination Products Coalition (company)
- ASTM Committee E55 (other)
- AAMI (company)
- ICH Q1 (other)
- ICH Q2 (other)
- ICH Q3 (other)
- ICH Q4 (other)
- ICH Q5 (other)
- ICH Q6 (other)
- ICH Q7 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- ICH Q11 (other)
- ICH Q12 (other)
- ICH Q13 (other)
- ICH Q14 (other)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-14-222-how-ich-guidelines-are-organized-understanding-the-q-s-e-and-m-series. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.