Process Validation and Regulatory Review in the Age of Expedited Approval Drugs
Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited approval drug, Chemistry, Manufacturing and Controls (CMC) data needs to be generated in about half the time of the traditional process.
Of course, an expedited approval classification does not mean that the drug developer can do less. In order to meet these accelerated timelines, analytical methods creation and product and process characterization needs to start sooner, and the process needs to be handled differently.
This paper explores those dynamics and offers some revised approach suggestions.