1.0 Introduction 2.0 Number of Intermediates and APIs batches produced 3.0 Review of output for all Isolated Intermediates and Finished Products 4.0 Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products 5.0 Summary of changes made during the year with respect ...

Annual product quality review is prepared in pharmaceuticals to review the conformity of products annually with respect to their quality including deviations, change control and market complaints. It is used as an effective product quality improvement tool. Annual product reviews verify the consistency ...