Quality by Design for Orally Inhaled Drug Products - PQRI

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What is Quality by Design?• ICH Q8(R1)– The pharmaceutical Quality by Design (QbD) is asystematic approach to development that begins withpredefined objectives and emphasizes product andprocess understanding and process control, based onsound science and quality risk management• Quality by Design Tools– Design of experiments (DoE)– Risk assessment– Process analytical technology (PAT)4
What Constitutes QbD?Labeled UseSafety and EfficacyDEFINE QualityTarget Product ProfileDESIGN Formulationand ProcessIDENTIFY Critical Material Attributesand Critical Process ParametersCONTROL Materialsand ProcessTARGET DESIGN IMPLEMENTATIONL. Yu. Pharm. Res. 25:781-791 (2008)5
Page 1 and 2: Quality by Design for Orally Inhale
Page 3: What is Pharmaceutical Quality?•
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 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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