Remove Genotoxicity Remove Life Science Remove Regulation
article thumbnail

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.