# 226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-02-11
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-11-226-ich-q4-explained-how-pharmacopeial-methods-are-accepted-across-regions
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/226---ICH-Q4-Explained-How-Pharmacopeial-Methods-Are-Accepted-Across-Regions-e3eu7ja

## Summary

Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q4 framework, which shifts the responsibility for pharmacopeial equivalence from sponsors to regulators via the Pharmacopoeial Discussion Group (PDG). He details how ICH Q4A establishes the harmonization process and Q4B provides the regulatory evaluation, specifically using ICH Q4B Annex 3(R1) on subvisible particulates as a practical example of method interchangeability. The episode highlights that while methods are generally interchangeable across ICH regions, specific conditions like the 100 mL nominal volume for parenteral products may require adherence to the most stringent criteria, such as those in the Japanese Pharmacopoeia.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-11-226-ich-q4-explained-how-pharmacopeial-methods-are-accepted-across-regions#t=0) Introduction to ICH Q Series and Pharmacopeial Harmonization
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-11-226-ich-q4-explained-how-pharmacopeial-methods-are-accepted-across-regions#t=0) Why ICH Q4 Exists and the Role of the PDG

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- ICH (other)
- PDG (other)
- Japanese Pharmacopoeia (other)
- European Pharmacopoeia (other)

## Related episodes from other shows

- [#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)
- [#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)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)
- [#370: Meet a Guru: Jamie Bihary](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-30-370-meet-a-guru-jamie-bihary) (Global Medical Device Podcast)

## Citing this page

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