# 250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-08-12
- Length: 11m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-08-12-250-pic-s-pi-006-4-2026-what-changed-in-qualification-validation
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/250---PICS-PI-006-4-2026-What-Changed-in-Qualification--Validation-e3n9m1r

## Summary

Subhi Saadeh, founder of Let's Combinate, analyzes the 2026 update to PIC/S PI 006-4, the first major revision to qualification and validation recommendations in nearly 20 years. He details how the document shifts from the 2007 PI 006-3 standard toward a lifecycle approach with stronger Quality Risk Management (QRM) and explicit statistical requirements for sampling and process capability. Saadeh highlights the removal of the rigid 'three-batch rule' and the clear distinction between Continuous Process Verification (CPV) for initial validation and Ongoing Process Verification (OPV) for routine manufacturing.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-08-12-250-pic-s-pi-006-4-2026-what-changed-in-qualification-validation#t=0) Introduction: Subhi Saadeh and PIC/S PI 006-4 Overview

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- PIC/S (company)
- PI 006-4 (other)
- PI 006-3 (other)
- EU Annex 15 (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- ICH Q11 (other)
- Annex 11 (other)
- Let's Combinate (company)

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- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-08-12-250-pic-s-pi-006-4-2026-what-changed-in-qualification-validation. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.