Verta Life Sciences consultants have extensive experience developing products following Quality by Design principles in compliance with ICH Q8

  • ICH Q8R(2): Design for Manufacture (DFM)- A systematic approach to design and developing reproducible and robust products, processes and analytical methods that follow the principles of Quality by Design (QbD).
  • DFM Process: used to meet QbD objectives of enhanced product, process and analytical understanding and control:
    • Define the Quality Targeted Product Profile (QTPP)
    • Determine the Critical Quality Attributes (CQAs)
    • Determine the raw material attributes and process parameters that potentially impact CQAs and perform risk analysis (Risk Assessment)
    • Develop a Design Space
    • Define and Implement a Control Strategy. (i.e. Process Analytical Technology (PAT)/Process Measurement Technology (PMT)/Secondary Process Automation (SPA))
    • Evaluate product through it life cycle & incorporate Continual Improvement.
KEY REGULATORY GUIDANCE SUPPORTING QbD
Key Regulatory Guidance supporting QbD