# 224 - ICH Q2 Explained: What Analytical Validation Really Requires

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-01-28
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-28-224-ich-q2-explained-what-analytical-validation-really-requires
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/224---ICH-Q2-Explained-What-Analytical-Validation-Really-Requires-e3e9s98

## Summary

Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q2 guideline for analytical procedure validation, emphasizing its role in harmonizing global regulatory expectations for drug substance, drug product, and the drug element of combination products. He details core validation characteristics including accuracy, precision, specificity, linearity, range, LOD, and LOQ, and clarifies the lifecycle relationship between ICH Q2 (validation) and ICH Q14 (development). Saadeh highlights a regulatory gap where device performance testing lacks equivalent ICH standards, noting that companies must distinguish between drug analytical methods and device mechanical testing. He provides practical guidance on efficiently reading the 38-page guideline and applying its framework to avoid rework and delays in regulatory submissions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-01-28-224-ich-q2-explained-what-analytical-validation-really-requires#t=0) Introduction: Subhi Saadeh and the Purpose of ICH Q2

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q2 (other)
- ICH Q14 (other)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- AAMI (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)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [Quality Management for IVD Devices vs Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices) (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/2026-01-28-224-ich-q2-explained-what-analytical-validation-really-requires. 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.