# 235 - ICH Q8: How Pharmaceutical Development Actually Works

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-04-22
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-22-235-ich-q8-how-pharmaceutical-development-actually-works
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/235---ICH-Q8-How-Pharmaceutical-Development-Actually-Works-e3i9408

## Summary

Subhi Saadeh, founder of Let’s ComBinate, explains the structure and practical application of ICH Q8 (Pharmaceutical Development), a guideline for harmonizing regulatory submissions. He details how to define the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) to build quality into the product by design rather than testing it in. Saadeh describes establishing a 'design space' through risk assessment and Design of Experiments (DoE) to define acceptable ranges for material attributes and process parameters. Finally, he outlines how this knowledge informs the control strategy and the organization of data within CTD Section 3.2.P.2.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-22-235-ich-q8-how-pharmaceutical-development-actually-works#t=0) Introduction and Structure of ICH Q8

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- ICH Q8 (other)
- Let’s ComBinate (company)
- CTD Section 3.2.P.2 (other)
- ICH Q12 (other)
- ICH Q9 (other)
- ISO 13485 (other)
- FDA 21 CFR 820.30 (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)

## Citing this page

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