PIC/S has published PI 006-4, the revised Recommendations on Qualification and Validation, superseding the 2007 PI 006-3 and entering into force on 1 October 2026. Cleaning validation now occupies a full chapter, with HBEL-driven scope, explicit limits on visual inspection and a clear position against continued test-until-clean practice.

Source: 30 Jul 2026regulator publication

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Inspection Watch

A validation promise needs an interim control strategy

FDA connects unvalidated cleaning on shared equipment with interim measures and the assessment of distributed products.

Source: 27 Jul 2026

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Inspection Watch

FDA Challenges a Visual-Only Cleaning Validation Strategy

A 2026 FDA warning letter to Dabur India rejects a shared-equipment cleaning programme that relied exclusively on visual inspection. The objection is narrower than it appears — and it turns on missing quantitative limits, not on visual inspection itself.

Source: 24 Jul 2026fda warning letter

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Regulatory Watch

Annex 15 Corrigendum: Small Text, Big Consequences for Cleaning Teams

EMA and PIC/S reissued the January 2026 Annex 15 concept paper in July 2026 with a new reference number and a substantially longer timetable. Nothing about cleaning validation itself changed — but the dates most teams are planning against did.

Source: 16 Jul 2026regulatory corrigendum

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FDA

EU GMP

EMA

Health Canada

MHRA

Regulatory and standards briefings.

PIC/S Publishes PI 006-4: A New Qualification and Validation Recommendation Takes Effect in October

A validation promise needs an interim control strategy

FDA Challenges a Visual-Only Cleaning Validation Strategy

Annex 15 Corrigendum: Small Text, Big Consequences for Cleaning Teams

Follow the sources.
Understand the significance.