ABSTRACT
Chemistry, manufacturing, and controls (CMC) submissions across multiple global markets are complex, time consuming, and knowledge intensive. This chapter provides a case study that describes how a formal knowledge-focused framework can be used to manage the overall regulatory submissions and product licensing lifecycle from R&D to post-market surveillance. This chapter describes elements selected as critical to knowledge management for generation of CMC regulatory documentation. Robust establishment of these knowledge management practices permitted introduction of further time- and resource-saving measures and best practice harmonization across multiple product modalities. One major goal of CMC regulatory documentation is to share specific knowledge about product and process understanding with health authorities, both at the time of regulatory submission of the license application, as well as throughout the product lifecycle commonly via post-approval submissions. Four knowledge management elements such as content generation, systems, timeline, and quality have been identified as critical for CMC regulatory documentation generation.
