# 223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-01-21
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-21-223-whats-changing-in-ich-q1-and-what-isnt-understanding-stability-expectations
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/223---Whats-Changing-in-ICH-Q1-and-What-Isnt-Understanding-Stability-Expectations-e3dvbc4

## Summary

Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, breaks down the 2025 draft update to the ICH Q1 stability guideline, explaining that the new 100+ page document consolidates legacy guidelines rather than introducing new science. She outlines core stability concepts such as time-dependency, the supportive role of accelerated aging, and the critical link between container-closure systems and product quality. Saadeh specifically addresses how ICH Q1 applies to drug-device combination products, noting that while shelf life is driven by the drug, device materials and in-use conditions significantly impact stability.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-21-223-whats-changing-in-ich-q1-and-what-isnt-understanding-stability-expectations#t=0) Introduction and Purpose of ICH Q1

## Topics

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

## Most relevant to

established companies

## Mentioned

- ICH Q1 (other)
- Let's Combinate BioWorks (company)
- ICH Q5C (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)
- [#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu) (Global Medical Device Podcast)
- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (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)
- [#418: Biocompatibility Brief - What Medical Device Companies Need to Know](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-04-418-biocompatibility-brief-what-medical-device-companies-need-to-know) (Global Medical Device Podcast)

## Citing this page

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