# 257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-10-05
- Length: 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-05-257-21-cfr-part-4-explained-cgmp-requirements-for-combination-products
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/257---21-CFR-Part-4-Explained-CGMP-Requirements-for-Combination-Products-e3ptchn

## Summary

Subhi Saadeh, a consultant and auditor specializing in combination products, explains the CGMP requirements under 21 CFR Part 4 for products containing both drug and device elements. She details the scope of single-entity and co-packaged products, the baseline expectation of meeting all applicable regulations, and the two compliance paths: full integration or a streamlined approach. Saadeh outlines specific ISO 13485 sections required for drug-based systems and 21 CFR Part 211 sections for device-based systems, highlighting complexities like management review differences and reserve sample storage.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-05-257-21-cfr-part-4-explained-cgmp-requirements-for-combination-products#t=0) Introduction and Scope of 21 CFR Part 4

## Topics

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

## Most relevant to

companies scaling up

## Mentioned

- 21 CFR Part 4 (other)
- ISO 13485 (other)
- QMSR (other)
- 21 CFR Part 211 (other)
- ICH Q10 (other)
- Tylenol (product)

## 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)
- [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)
- [How to Choose the Right FDA Regulatory Pathway for your Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device) (Global Medical Device Podcast)

## Citing this page

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