There are clear gaps in understanding in the market of combination products. A major one was highlighted at a recent workshop sponsored by West. A survey showed that over 20% of attendees were not aware of the considerations needed to build a control strategy.
A control strategy is defined as a planned set of controls, derived from product and process understanding, that assures process, performance, and product quality.1 Building a control strategy starts with understanding the product and process; this understanding must begin in development. More specifically, building a control strategy comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters.