The answer is given in the full text of the EU Guidelines to Good Manufacturing Practice Part I, Chapter 1: “The manufacturer and, where different, marketing authorisation holder should evaluate the results of the review and an assessment made as to whether corrective and preventive action or any revalidation should be undertaken, under the Pharmaceutical Quality System. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection. (…) Where the marketing authorisation holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the product quality review.”
The marketing authorisation holder is a key player and must have a copy of the PQR. How else could he be able to evaluate the result of this review?
