Drug-device combinations with complex controls or unexpected device operation can lead to increased patient risk. Combination Products Risk Management integrates human factors and other control strategies to enable effective design that promotes human well-being and overall system performance.
As pharmaceutical companies develop combination products, new and complex interactions among packaging components and delivery systems arise. It is critical to understand the compatibility and performance of the primary packaging system with both drug product and delivery systems for successful development of the control strategy. Developing and applying a strategy for component and system qualification helps ensure drug product quality, safety and efficacy. Manufacturers must understand chemical compatibility and the physical and functional aspects of these components and devices as a single system. Several key areas should be considered for analytical testing during development, namely: compendia, biocompatibility, extractables and leachables, container closure integrity, performance, potential particle generation and stability analysis.