# 234 - ICH Q7: The GMP Framework for API Manufacturing

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-04-15
- Length: 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-15-234-ich-q7-the-gmp-framework-for-api-manufacturing
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/234---ICH-Q7-The-GMP-Framework-for-API-Manufacturing-e3htt99

## Summary

Subhi Saadeh, Founder of Let’s ComBinate, provides a detailed walkthrough of ICH Q7, the GMP framework for Active Pharmaceutical Ingredient (API) manufacturing. He explains that unlike other guidelines, Q7 covers the full lifecycle from API starting materials through production, validation, and quality management systems (QMS). Key decisions discussed include defining the start of GMP via Table 1, establishing independent quality units, and managing Contract Manufacturing Organizations (CMOs) with strict audit rights. The episode highlights the flexibility allowed for clinical trial APIs (Section 19) and the scaling of controls as processes mature from early synthesis to final packaging.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-15-234-ich-q7-the-gmp-framework-for-api-manufacturing#t=0) Introduction: Subhi Saadeh and ICH Q7 Overview

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q7 (other)
- Let’s ComBinate (company)
- Pfizer (company)
- Gilead (company)
- Baxter (company)
- ICH Q11 (other)
- ICH 15378 (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)
- [#444: Scaling Your QMS: What the FDA Really Expects for MedTech Startups](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-30-444-scaling-your-qms-what-the-fda-really-expects-for-medtech-startups) (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)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [Meet a Guru: Tom Rish](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish) (Global Medical Device Podcast)

## Citing this page

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