CMC Workshop 2015

The Points to Consider ICH Endorsed Guide for ICH Q8/Q9/Q10 Implementation describes the use of models and their categorization from high to low impact depending on level of risk to patient when used as part of the control strategy. There are a variety of ways that this information can be incorporated into the control strategy to assure product quality and process consistency as part of a marketing application. This session will look at a variety of ways that models have been used to support marketing applications, the data and statistical analysis that was needed gain approval, and some considerations of how this could evolve in the future. For example a Design Space may be associated with RTRT, or may be part of a control strategy that includes extensive end-product testing; consequently the degree of assurance and the level of statistical confidence required can vary.