Pharmaceutical Development: ICH Q8/Q(8)R

More documents

Recommendations

Info

Example QbD Approach (<strong>ICH</strong> <strong>Q8</strong>R) QTPP CQAs Risk assessment Design space Control strategy Continual Improvement • Target the product profile • Determine critical quality attributes (CQAs) • Link raw material attributes and process parameters to CQAs and perform risk assessment • Develop a design space • Design and implement a control strategy • Manage product lifecycle, including continual improvement 14
Product profile CQAs Risk assessment Design space Control strategy Continual Improvement Quality Target Product Profile “Begin with the end in mind” • Summary of the quality characteristics of a drug product to ensure safety and efficacy • Includes, but not limited to: • Dosage form • Route of administration • Pharmacokinetic characteristics • e.g., dissolution, aerodynamic performance • Quality characteristics for intended use • e.g., sterility, purity 15
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: ICH Q 10: Why Focus on PQS? • The
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

Create successful ePaper yourself

Delete template?

Save as template?