PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.
In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to.
A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV).
The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking.
Chapters
00:00 Big Update Overview
01:02 Who PIC/S Serves
01:28 Annex 15 Relationship
02:12 Scope and Exclusions
02:39 Why Update Now
04:05 Four Key Changes
04:47 Risk and Lifecycle Shift
06:43 Statistics and Sampling
07:48 Rethinking the Three-Batch Rule
08:30 Ongoing Process Verification
09:11 Traditional, CPV and Hybrid Approaches
10:45 Key Takeaways
About Subhi
Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.
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Documents Discussed
PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)
https://picscheme.org/docview/11277
PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)
https://picscheme.org/docview/3447
EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf
PIC/S Publications Page
https://picscheme.org/en/publications
