# 239 - ICH Q11 in 6 Minutes

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-05-20
- Length: 6m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-20-239-ich-q11-in-6-minutes
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/239---ICH-Q11-in-6-Minutes-e3jke8m

## Summary

Subhi Saadeh, founder of Let’s Combinate, breaks down ICH Q11 guidelines for drug-device combination products, focusing on three key sections: manufacturing process development, starting materials, and control strategy. He explains how the drug substance process connects to the final drug product quality and emphasizes the importance of defining the boundary where the manufacturing process begins. Saadeh contextualizes Q11 within the broader ICH framework, including Q7, Q8, Q9, and Q10, to help those from medical device or non-chemistry backgrounds understand the regulatory requirements.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-20-239-ich-q11-in-6-minutes#t=0) Introduction and ICH Q11 Overview

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- ICH Q11 (other)
- ICH Q7 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- ICH Q12 (other)
- Let’s Combinate (company)

## Related episodes from other shows

- [#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)
- [#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)
- [#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)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (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)

## Citing this page

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