Quality by Design for Orally Inhaled Drug Products - PQRI

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Control StrategiesLevel 1: Extensive end producttesting + Fixed Critical ProcessParameters (CPPs)Level 2: Reduced end product testing+ Flexible manufacturing processwithin fixed design spaceLevel 3: PAT, Real-time automatic“engineering control”+Flexible manufacturing processLevel ofControlLevel ofFreedomIncrease25
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 and 16: Device Considerations• Device mat
Page 17 and 18: Process Development• Understand i
Page 19 and 20: Design Space• Design Space- The m
Page 21 and 22: IPAC-RS (1998-2003)• Nonparametri
Page 23: 2005 FDA ACPS Meeting Outcome• FD
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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