Hardware Podcasts

183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products

Let's Combinate · 9 Apr 2025 · 37m

What this episode covers

Subhi Saadeh, a bioengineer and host of Let's Combinate, explains the Good Practice guidelines (GXPs) that govern the lifecycle of regulated medical devices and pharmaceuticals. He details the specific roles of GMP, GLP, GCP, GDP, GVP, and GAMP, emphasizing how they integrate to ensure product safety, efficacy, and quality. The discussion covers regulatory frameworks like 21 CFR 820, 21 CFR 58, and ICH E6 R1, highlighting the transition from preclinical research to post-market surveillance. Saadeh stresses that these principles form a continuous, interconnected framework essential for protecting public health and maintaining data integrity across the entire supply chain.

Most relevant to

large enterprises

Topics

Mentioned

Also
Let's Combinate, Subhi Saadeh, Marta New, Nathan Roman, Combination Products Coalition, ASTM Committee E55, AAMI, OECD, ICH, FDA, ISPE

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