Pharmaceutical Development: ICH Q8/Q(8)R

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Describing Design Spaces • Linear Ranges of Parameters • Mathematical Relationships • Time-dependent functions • Combinations of variables • e.g., Principle components of multivariate model • Scaling Factors • Single or multiple unit operations The applicant decides how to describe and present the design space 20
Design Spaces Example #1 Surface Plot Contour Plot 100.0 2 Dissolution (%) 95.0 90.0 85.0 80.0 75.0 70.0 65.0 60.0 55.0 50.0 40 Parameter 1 50 60 0 1 2 Parameter 2 Design Space (linear ranges) Design Space (non-linear) 0 40 42 44 46 48 50 52 54 56 58 60 Parameter 1 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 Parameter 2 Dissolution (%) 90.0-95.0 85.0-90.0 80.0-85.0 75.0-80.0 70.0-75.0 65.0-70.0 60.0-65.0 • Design space can be described as a mathematical function or simple parameter range • Operation within design space will result in a product meeting the defined quality attributes 21
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: Design Space Determination • Firs
Page 23 and 24: Quality Control Strategy Product pr
Page 25 and 26: QbD Concepts in Development and Man
Page 27 and 28: ONDQA’s QbD Pilot Program • Obj
Page 29 and 30: CMC Pilot Program - Design Space Ob
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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