# 163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-11-20
- Length: 11m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-20-163-ich-q12-established-conditions-post-approval-changes-pacmps-and-the-pharma-l
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/163---ICH-Q12--Established-Conditions--Post-Approval-Changes--PACMPs--and-the-Pharma-Lifecycle-e2r2d3d

## Summary

Host Subhi Saadeh explains ICH Q12, a regulatory guideline for pharmaceutical lifecycle management that specifically addresses drug-device combination products. He details how the framework uses 'established conditions' (ECs) to streamline post-approval changes, reducing regulatory friction and improving patient access. The episode breaks down key concepts including Product Lifecycle Management (PLCM) documents and Post-Approval Change Management Protocols (PACMPs) to help sponsors navigate complex regulatory submissions more efficiently.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-20-163-ich-q12-established-conditions-post-approval-changes-pacmps-and-the-pharma-l#t=0) Introduction: ICH Q12 and Established Conditions

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

large enterprises

## Mentioned

- ICH Q12 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- ISO 14971 (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)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#389: Pre-determined Change Control Plans](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-31-389-pre-determined-change-control-plans) (Global Medical Device Podcast)
- [CDRH Proposed Guidance for FY 2023](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023) (Global Medical Device Podcast)

## Citing this page

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