# 225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-02-04
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-04-225-ich-q3a-q3b-q3c-q3d-and-q3e-explained-in-10-minutes
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/225---ICH-Q3A--Q3B--Q3C--Q3D-and-Q3E---EXPLAINED-in-10-Minutes-e3ek4j9

## Summary

Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q3 family of guidelines, which establish a risk-based framework for controlling impurities in drug substances and products. He details how Q3A covers drug substance synthesis, Q3B addresses drug product degradation, and Q3C and Q3D manage residual solvents and elemental metals. The episode highlights Q3E, which governs extractables and leachables from drug delivery systems and combination products, emphasizing iterative risk assessment over eliminating all risk.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-04-225-ich-q3a-q3b-q3c-q3d-and-q3e-explained-in-10-minutes#t=0) Introduction to ICH Q3 and Impurity Sources

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- ICH Q3 (other)
- Q3A (other)
- Q3B (other)
- Q3C (other)
- Q3D (other)
- Q3E (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)
- [#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)
- [#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/2026-02-04-225-ich-q3a-q3b-q3c-q3d-and-q3e-explained-in-10-minutes. 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.