Revision of PIC/S PI 006 - complete Modernisation of this Qualification and Validation Guideline

On 30 July 2026 the PIC/S announced to publish a new version of document PI 006 about Validation and Qualification. Overall, the document represents a broad modernisation and is closely aligned with the Annex 15 revision in 2015. The new version 04 describes current expectations regarding lifecycle approaches, Quality Risk Management (QRM), and data integrity. The document will come ínto force on 1st October 2026.

Key takeaway: Qualification and validation are positioned as lifecycle activities, with the extent and depth of work determined by scientific rationale and risk-based decision-making. The most important changes are:

• Retrospective validation is explicitly stated to be no longer acceptable
• The traditional expectation of “three validation batches” is replaced by a scientifically justified, risk-based approach
• Lifecycle validation becomes the central concept
• QRM in line with ICH Q9 (R1) is embedded throughout and is the basis for the scope and depth of qualification and validation activities
• Performance Qualification (PQ) and Ongoing/Continued Process Verification (OPV/CPV) are strengthened and has greater emphasis than before

Newly added or substantially expanded topics are

•     Transportation verification
•     Validation of Packaging 
•     Utilities qualification
•     Validation of Test Methods 
•     Pre-qualification stages
•     Cleaning validation is more detailed (visual inspection, HBEL-based approaches, ongoing cleaning verification)

The document is available on the PIC/S website.

Resumee: The version 04 has significant changes compared to version 3.0. It is the most modern guideline about Validation and Qualification at the moment.