Hardware Podcasts

237 - ICH Q10: The Pharmaceutical Quality System

Let's Combinate · 6 May 2026 · 8m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, explains the ICH Q10 guideline on the Pharmaceutical Quality System (PQS), distinguishing it from certifiable standards like ISO 9001 and ISO 13485. He details how PQS augments regional GMPs across the product lifecycle, emphasizing phase-appropriate controls and management responsibility for outsourced activities. The episode covers the four core PQS elements—process performance monitoring, CAPA, change management, and management review—and their role in continual improvement.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Let’s Combinate
Also
ICH Q10, ISO 9001, ISO 13485, ICH Q8, ICH Q9

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