# 233 - Most Teams Misunderstand Specifications | ICH Q6

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-04-08
- Length: 6m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/233---Most-Teams-Misunderstand-Specifications--ICH-Q6-e3hj6e4

## Summary

Subhi Saadeh, founder of Let’s Combinate and former member of the ICH Q6(R1) subteam, explains the critical role of specifications in defining and controlling drug products and drug-device combination products. He breaks down the three core components of a specification—attributes (CQAs), methods, and acceptance criteria—and distinguishes between ICH Q6A for small molecules and Q6B for biologics. Saadeh highlights key themes from the 2024 ICH Q6(R1) concept paper, including the alignment of principles across Q6A and Q6B, the expansion of scope to include new modalities like gene therapies, and the shift toward science- and risk-based lifecycle management linked to ICH Q12.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6#t=0) Introduction and Host Background
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6#t=0) The Purpose and Structure of ICH Q6
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6#t=0) Defining Specifications: Attributes, Methods, and Limits
- [4:25](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6#t=265) ICH Q6(R1) Concept Paper Themes and Updates

## Topics

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

## Most relevant to

established companies

## Mentioned

- Let’s Combinate (company)
- ICH Q6 (other)
- ICH Q6A (other)
- ICH Q6B (other)
- ICH Q12 (other)
- HPLC (tool)

## 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)
- [#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)
- [#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)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (The Pragmatic Embedded 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)

## 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/2026-04-08-233-most-teams-misunderstand-specifications-ich-q6. 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.