ICH Q9 Applied to Small Molecule Process Development, Scale-up and Implementation

ICH Q9 principles have been employed at Merck to inform risk-based product and process development for small molecule pharmaceuticals. Quality Risk Management principles are employed during development of the final formulation, during process development, scale-up and installation into the commercial manufacturing facility. This talk will discuss the philosophy behind the tools we have developed in the small molecule development space, as well as how the tools and business processes facilitate knowledge sharing across functional boundaries (formulation and process, API and Pharm, and development and manufacturing).