# 241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-06-10
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-10-241-ich-q14-explained-have-we-been-validating-methods-backwards
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/241---ICH-Q14-Explained-Have-We-Been-Validating-Methods-Backwards-e3kj7lg

## Summary

Subhi Saadeh, Founder of Let's Combinate, explains the core concepts of ICH Q14, focusing on the shift from traditional validation to a science- and risk-based analytical procedure lifecycle. He details how the Analytical Target Profile (ATP) defines method requirements and drives technology selection, risk assessment, and development before formal validation under ICH Q2. Saadeh highlights the connection between ICH Q14 and ICH Q12, emphasizing that robust lifecycle management and prior knowledge facilitate flexible change management for established conditions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-10-241-ich-q14-explained-have-we-been-validating-methods-backwards#t=0) Introduction: ICH Q14 vs. Q2 and the ATP

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q14 (other)
- ICH Q2 (other)
- ICH Q12 (other)

## 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/2026-06-10-241-ich-q14-explained-have-we-been-validating-methods-backwards. 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.