Quality by Design for Orally Inhaled Drug Products - PQRI

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Development of Equivalent DPIs• Constraints for formulation design– Q1 the same; Q2 the same preferred– Manufacturability• Constraints for device design– Similar shape– Equivalent design and operating principle– Comparable device resistance16
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
Page 1 and 2: Quality by Design for Orally Inhale
Page 3 and 4: What is Pharmaceutical Quality?•
Page 5 and 6: What Constitutes QbD?Labeled UseSaf
Page 7 and 8: Dry Powder Inhalers• Contain micr
Page 9 and 10: Quality Target Product Profile• A
Page 11 and 12: Quality Target Product Profile for
Page 13 and 14: Formulation Considerations• Physi
Page 15: Device Considerations• Device mat
Page 19 and 20: Design Space• Design Space- The m
Page 21 and 22: IPAC-RS (1998-2003)• Nonparametri
Page 23 and 24: 2005 FDA ACPS Meeting Outcome• FD
Page 25 and 26: Control StrategiesLevel 1: Extensiv
Page 27 and 28: Level 2 ControlWDS = Within Design
Page 29 and 30: Control Variability• There is unc

Quality by Design for Orally Inhaled Drug Products - PQRI

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