# 177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-02-26
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-26-177-the-gxps-that-run-pharma-medical-devices-gmp-gdp-gcp-glp-gvp-gamp-explained
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/177---The-GXPs-That-Run-Pharma--Medical-Devices-GMP--GDP--GCP--GLP--GVP--GAMP-EXPLAINED-e2vagko

## Summary

Host Subhi Saadeh explains the six key GXPs (Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices, Good Distribution Practices, Good Pharmacovigilance Practices, and Good Automated Manufacturing Practices) that govern the safety and quality of pharmaceutical and medical device products. He details how each regulation addresses specific stages of the product lifecycle, from preclinical testing and human trials to manufacturing, distribution, and post-market monitoring. Saadeh emphasizes that these frameworks, including FDA regulations like 21 CFR 820 and 21 CFR Part 11, work together to protect public health and ensure data integrity across the industry.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-26-177-the-gxps-that-run-pharma-medical-devices-gmp-gdp-gcp-glp-gvp-gamp-explained#t=1) Introduction to GXPs

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- OECD (company)
- ISO 13485 (other)
- ISO 17025 (other)
- DSCSA (other)
- Falsified Medicine Directive (other)
- 21 CFR 820 (other)
- 21 CFR Part 11 (other)
- EU Annex 11 (other)

## Related episodes from other shows

- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (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)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [#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)
- [Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-02-crash-course-on-greenlight-guru-academy-how-medical-device-professionals-stay-ah) (Global Medical Device Podcast)

## Citing this page

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