Pharmaceutical Development: ICH Q8/Q(8)R

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ICH Q9: Quality Risk Management • A systematic process for the assessment, control, communication and review of risks to the quality of the drug product • Guidance includes principles and examples of tools for quality risk management • Evaluation of risk to quality should: • be based on scientific knowledge • link to the protection of the patient • Applies over product lifecycle: development, manufacturing and distribution 10
Quality Risk Management Process Process Development Control Strategy Development Continual Improvement 11
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: ICH Q9 and Q10 • Key enablers •
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 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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