Pharmaceutical Development: ICH Q8/Q(8)R

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Outline • Recent ICH and FDA Guidances • ICH Q8 and Q8(R) • Quality by Design (QbD) • Example Approach to QbD • QbD for APIs • FDA Experience with QbD • ONDQA QbD Pilot Program • Challenges of Implementing QbD • Concluding Remarks 2
Recent ICH & FDA Guidances Product Design Process Design Manufacturing Process Monitoring/ Continuous Verification ICH Q8/Q8(R) - Pharmaceutical Development FDA PAT Guidance ICH Q9 – Quality Risk Management ICH Q10 – Pharmaceutical Quality Systems 3
Page 1: Pharmaceutical Development: ICH Q8/
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 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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