Quality by Design for Orally Inhaled Drug Products - PQRI

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Level 3 ControlUFC = Under Feedback ControlAPI, Flexible particle sizeMCC, Flexible particle sizeCroscarmellose NaMg stearateDrugproductPAT“PAT”“” = …Flexible order of additionFlexible load levelUFC # of revolutionsUFC pre-compression forceUFC compression forceUFC press speedUFC feeder speed28
Control Variability• There is uncharacterized variability in theexcipients and process– Level 1 handles variability by excessivelytesting– Level 2 handles variability by limited testingand establishing design space for criticalmaterial attributes and process parameters– Level 3 is a robust process that can ensurequality in the presence of uncharacterizedvariability29
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 and 24: 2005 FDA ACPS Meeting Outcome• FD
Page 25 and 26: Control StrategiesLevel 1: Extensiv
Page 27: Level 2 ControlWDS = Within Design

Quality by Design for Orally Inhaled Drug Products - PQRI

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