When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), one of the obvious questions is How far should you go into the E&L-qualification process? As the drug product is in a solid state, you would expect that the interaction between the LDP and the components of its container would be low. But is this really the case?
The presentation will provide a view on the current status of regulatory requirements and will address some of the fallacies that exist in E&L qualifications for lyophilized drug products.
Learn more about the presenters below.