Reply To: Documentation of review of PV documents after PSUR review by EMA

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#8177

Dear PIPA Member,

Thank you for posting your question.

I would say that if you already have a regulatory tracking and archiving system or a different type of procedural tracking tool in place, then there is no reason why some kind of checklist/form cannot be implemented to show evidence that no further updates were required to the relevant PV documents. I would recommend that when a document is being written or an update to the PV document is needed, an Impact Analysis Report could be utilized to document how it was assessed that other documents did not require an update. This could then be signed off by the QPPV, Head of PV etc who is confirming  that no further updates were required and the reason why this decision was made. Should you go down this path, document this process in your local SOP.

I do hope this helps with your enquiry.

Kindest regards

PIPA