# 237 - ICH Q10: The Pharmaceutical Quality System

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-05-06
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-06-237-ich-q10-the-pharmaceutical-quality-system
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/237---ICH-Q10-The-Pharmaceutical-Quality-System-e3iuvhf

## Summary

Subhi Saadeh, founder of Let’s Combinate, explains the ICH Q10 guideline on the Pharmaceutical Quality System (PQS), distinguishing it from certifiable standards like ISO 9001 and ISO 13485. He details how PQS augments regional GMPs across the product lifecycle, emphasizing phase-appropriate controls and management responsibility for outsourced activities. The episode covers the four core PQS elements—process performance monitoring, CAPA, change management, and management review—and their role in continual improvement.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-06-237-ich-q10-the-pharmaceutical-quality-system#t=0) Introduction to ICH Q10 and Lifecycle

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- ICH Q10 (other)
- ISO 9001 (other)
- ISO 13485 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- Let’s Combinate (company)

## 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)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [We Achieved ISO Certification! Now What?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what) (Global Medical Device Podcast)
- [How to Build a QMS for a Medical Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (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/2026-05-06-237-ich-q10-the-pharmaceutical-quality-system. 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.