A product quality review is generally expected annually. Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. Even if no manufacturing has occurred in the review period, the quality review should be conducted as per section [ICH Q7, Section 2.50] and include stability, returns, complaints, and recalls. For example, a product quality review may encompass more or less than 12 months depending upon product campaign duration [ICH Q7, Section 2.50; ICH Q10, Section 2.6].
