Hardware Podcasts

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

Let's Combinate · 26 Feb 2025 · 10m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, OECD
Also
ISO 13485, ISO 17025, DSCSA, Falsified Medicine Directive, 21 CFR 820, 21 CFR Part 11, EU Annex 11

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