ABSTRACT
The quality, safety and performance of a combination product is dependent on the materials, device components, constituent parts and finished drug. Combination Products raise new quality and safety concerns for raw materials in device components and constituent parts which may come into contact with the drug constituent, and potentially impact the quality, safety and performance of the finished product. The focus of this chapter is on quality and safety of materials, device components and device constituent parts used in a combination product whether internally manufactured or purchased. The chapter covers best practices that a raw material, component or constituent part supplier and a Combination Product manufacturer can proactively adopt to assure patient safety. It also presents practical steps that combination product manufacturers and suppliers of materials, components and constituent parts can take to ensure compliance with regulatory standards, and ultimately, with assuring patient safety.
