Quality by Design for Orally Inhaled Drug Products - PQRI

Process Development• Understand impact of material attributes andprocess parameters on product CQAs and thetarget quality profile• Identify critical process parameters and inputmaterial attributes that must be controlled toachieve product CQAs.• Use risk assessment to prioritize processparameters and material attributes forexperiment verification• Combine prior knowledge with experiments toestablish a design space or other representationof process understanding17