Industry news
PIC/S replaces its qualification and validation recommendations with PI 006-4
On 30 July 2026, PIC/S published PI 006-4, revised recommendations on qualification and validation. It took effect on 1 October 2026 and replaces PI 006-3 of 25 September 2007.
By ZY Cleanroom · Updated · Sources at the end of the page
What changed
The new document is 49 pages and carries a new title, Recommendations on Qualification and Validation. It says it follows the 2015 revision of Annex 15 to the PIC/S and EU GMP Guide. It applies to active ingredients and finished dosage forms alike. It leaves computerised systems to Annex 11.
Its sections cover the validation master plan, the stages of qualification, process validation, supporting utilities and cleaning validation. PI 006-3 covered the validation master plan, IQ and OQ, non-sterile process validation and cleaning validation. PI 006-4 supersedes it. PIC/S news of 30 July 2026 says a dedicated working group wrote it. The UK MHRA chaired it first. Ireland's HPRA and the US FDA later chaired it jointly.
Points that reach cleanroom projects
The source for the points below is PI 006-4, effective 1 October 2026.
Supporting utilities include ventilation systems. The document says the same qualification path applies to utilities, with user requirements, factory and site acceptance tests, and IQ, OQ and PQ. It says validation effort should go first to utilities in direct contact with the product.
The planning section asks teams to weigh the risk of cross-contamination when equipment, utilities or HVAC systems are shared.
On requalification, every change to a facility, utility or system goes through change control. A like-for-like change may be handled in routine maintenance if the decision is written down, justified and approved by the quality unit. Reviews should happen at set intervals, and the document warns that a series of minor changes can add up to a major one.
What a facility owner should check next
Compare your validation master plan and your IQ, OQ and PQ templates with the new sections. Check whether your HVAC change records show how like-for-like decisions were approved. Check that your review interval for rooms and air handling units is written down, with a reason for it.
The document guides inspectors and industry. It is not a law. Ask your regulator whether it applies it. If you are planning a cleanroom, you can send ZY Cleanroom your room list.
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184