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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-06-03
- Length: 11m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-03-240-ich-q13-continuous-manufacturing-batches-residence-time-distribution-and-con
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/240---ICH-Q13-Continuous-Manufacturing--Batches--Residence-Time-Distribution-and-Control-Strategy-e3k8o4c

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-03-240-ich-q13-continuous-manufacturing-batches-residence-time-distribution-and-con#t=0) Introduction to ICH Q13 and the Batch Challenge

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- ICH Q13 (other)
- Residence Time Distribution (other)
- Process Analytical Technology (other)

## Related episodes from other shows

- [#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)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)

## Citing this page

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