Pharmaceutical Development: ICH Q8/Q(8)R

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Why QbD? • Higher level of assurance of product quality • Cost saving and efficiency for industry • Increase efficiency of manufacturing process • Minimize/eliminate potential compliance actions • Provide opportunities for continual improvement • Facilitate innovation • More efficient regulatory oversight • Enhance opportunities for first cycle approval • Streamline post approval manufacturing changes and regulatory processes • More focused PAI and post approval cGMP inspections 6
ICH Q8R • Annex to ICH Q8 • Describes principles of QbD vs. minimal approach • Provides further clarification of key concepts of Q8 • Provides illustrative examples • Details provided in the next Presentation -Brian Withers, Abbott Laboratories 7
Page 1 and 2: Pharmaceutical Development: ICH Q8/
Page 3 and 4: Recent ICH & FDA Guidances Product
Page 5: QbD Definition (ICH Q8(R)) A system
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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