Hardware Podcasts

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

Let's Combinate · 3 Jun 2026 · 11m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, explains the regulatory framework of ICH Q13, which addresses how pharmaceutical companies can apply traditional quality concepts like batch definition, traceability, and control strategy to continuous manufacturing. He details the three continuous manufacturing models, the critical role of Residence Time Distribution (RTD) for identifying impacted material during disturbances, and how control strategies must evolve to monitor processes during startup, steady-state, and deviations. Saadeh also covers validation, parametric release, and lifecycle management in the context of non-stop production.

Most relevant to

established companies

Topics

Mentioned

Also
ICH Q13, Residence Time Distribution, Process Analytical Technology

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