The product review is expected annually. Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. The timeframe criteria should be established in a SOP. The trending can include results gathered the previous period to ensure its robustness. Even if no manufacturing has occurred in the review period, the quality and regulatory review should be conducted as per section 1.10 and include stability results, returns, complaints, recalls, deviations (including those arising qualification and validation activities) and regulatory background. The review of the last PQR should also be conducted.
EU GMP guide part I: Basic requirements for medicinal products: Chapter 1: Pharmaceutical quality system
