This study set out to establish the typical sources of product and process knowledge currently used to support decision-making for post-approval changes and continuous improvement strategies. It explores whether it is standard practice within industry to utilise the prior knowledge available within the CTD to support day-to-day lifecycle management. It also explores the potential benefits of leveraging the Quality Overall Summary (QoS), Module 2 of the CTD, to support ongoing management of knowledge throughout the commercial manufacturing and post-market operations.
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