Quality by Design for Orally Inhaled Drug Products - PQRI

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Delivered Dose Uniformity• Delivered dose uniformity– Within a container for multiple dose products– Between containers– Between batches• Delivered dose uniformity testing documented inthe– FDA Metered Dose Inhaler (MDI) and Dry PowderInhaler (DPI) Drug Products - CMC Documentation(Draft, October 1998)– Nasal Spray and Inhalation Solution, Suspension, andSpray Drug Products - CMC Documentation (Final,July 2002)20
IPAC-RS (1998-2003)• Nonparametric limit tests– Counts the number of determinations in a samplewithin and outside certain pre-fixed limits• “NMT 1 of 9 determinations outside 80 - 120% of label claim• 0 outside 75 - 125% of label claim”• Too stringent to encompass all product types– High potential for failing good batches– OINDP cannot routinely meet expectations in draftGuidances, e.g., many products have been approvedwith exception to DDU tests acceptance criteria inpublished Guidanceshttp://www.fda.gov/ohrms/dockets/ac/03/slides/3996s1.htm21
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: Design Space• Design Space- The m
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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