Quality by Design for Orally Inhaled Drug Products - PQRI

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Process Identification andUnderstanding: ConceptINPUTS(X)ProcessEquipmentMaterialY = ƒ(X)Priori knowledgeRisk AssessmentDesign ofExperimentsInputs to the processcontrol variabilityof the OutputYOUTPUTEnvironment18
Design Space• Design Space– The multidimensional combination and interaction ofinput variables (eg. material attributes) and processparameters that have been demonstrated to provideassurance of quality• Regulatory Implication– Movement out of the design space is considered tobe a change and would normally initiate aregulatory post-approval change process. Designspace is proposed by the applicant and is subject toregulatory assessment and approval19
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: Process Development• Understand i
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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