Proper Execution of Annual Product Reviews

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product. If done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management. “Reviews” are a critical element of any Quality Management System. Regular reviews of process and quality system performance is necessary to ensure product quality. All regulatory authorities require “reviews.”