Pharmaceutical Development: ICH Q8/Q(8)R

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Examples of Design Space in Recent NDAs • Excipient attributes • Degree of polymer substitution • Viscosity/molecular weight distribution • Particle size distribution • Drug substance attributes • Particle size distribution • Process parameters • Drug substance unit operations • Drug product unit operations • Effect of scale-up considered • Effect of equipment type understood 28
CMC Pilot Program – Design Space Observations • Most applications included a design space for drug product; some for drug substance • Most included design spaces for process parameters; some included formulation component properties • Methods for determining design space included: • One variable at a time experiments • Statistically designed experiments (DOE’s) • Modeling approaches 29
Page 1 and 2: Pharmaceutical Development: ICH Q8/
Page 3 and 4: Recent ICH & FDA Guidances Product
Page 5 and 6: QbD Definition (ICH Q8(R)) A system
Page 7 and 8: ICH Q8R • Annex to ICH Q8 • Des
Page 9 and 10: ICH Q9 and Q10 • Key enablers •
Page 11 and 12: Quality Risk Management Process Pro
Page 13 and 14: ICH Q 10: Why Focus on PQS? • The
Page 15 and 16: Product profile CQAs Risk assessmen
Page 17 and 18: Risk Assessment (ICH Q9) Product pr
Page 19 and 20: Design Space Determination • Firs
Page 21 and 22: Design Spaces Example #1 Surface Pl
Page 23 and 24: Quality Control Strategy Product pr
Page 25 and 26: QbD Concepts in Development and Man
Page 27: ONDQA’s QbD Pilot Program • Obj
Page 31 and 32: CMC Pilot Program - Risk Assessment
Page 33 and 34: Challenges of Implementing QbD •
Page 35: Pathway to the Desired State The De

Pharmaceutical Development: ICH Q8/Q(8)R

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