Pharmaceutical GMP Professional

After approval, a manufacturer plans to increase the batch size of an immediate-release tablet and to change a manufacturing process parameter. The regulatory affairs group must determine the appropriate reporting category based on the potential impact of these changes. Which framework is specifically referenced in the CPGP body of knowledge for assessing such post-marketing changes?

A regulatory affairs specialist is asked to describe monitoring requirements applied after a product is on the market, specifically covering both risk evaluation and mitigation strategy activities and pharmacovigilance. Under which sub-topic of Regulatory Agency Reporting does this responsibility fall?