PIC/S: Revised Recommendations on Qualification and Validation
PIC/S has published a fundamentally revised version of its “Recommendations on Qualification and Validation” (PI 006-4). The new document was issued on 30 July 2026, will enter into force on 1 October 2026, and replaces the 2007 edition. The revised document has been expanded from 26 to 49 pages.
The revised recommendations consistently apply a lifecycle and risk-based approach to qualification and validation. They include expanded guidance on quality risk management, data governance and data integrity, change control, performance qualification and ongoing process verification.
The chapters on process validation and cleaning validation have also been extensively updated. PIC/S states that the number of validation batches should be scientifically justified using a risk-based approach and explicitly describes the reference in Annex 15 PIC/S / EU GMP Guide to three consecutive validation batches as a transitional provision. The cleaning validation chapter now provides additional recommendations on HBELs, worst-case selection, manual cleaning and ongoing cleaning verification.
Although PI 006-4 is a recommendation rather than a legally binding GMP requirement, it clearly reflects the current expectations of PIC/S inspectorates. Several topics go beyond the current Annex 15 and may indicate the direction of its ongoing revision.
Our GMP expert Dr. Sabine Paris has analyzed the most important changes for you and compiled them in a PDF.
Source:
PIC/S: Recommendations on Qualification and Validation PI 006-4
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