FDA Perspective on Quality by Design (QbD) in Pharmaceutical Development

Over the last five years, FDA and ICH quality initiatives created a paradigm shift in pharmaceutical discovery, development, and manufacturing.  At the 17th International Process Development Conference, Christine Moore gave a presentation on the FDA perspective on Quality by Design (QbD) in pharmaceutical development.  During her presentation, Christine discussed the advantages that the U.S. Food and Drug Administration (FDA) believes Quality by Design offers, including:

1.Quality by Design (QbD) provides a higher level of assurance of drug product quality.
2. Quality by Design (QbD) offers costs savings and efficiency for the pharmaceutical industry:

  • Facilitates innovation for unmet medical needs
  • Increase efficiency of pharmaceutical manufacturing processes and reduces manufacturing costs and product rejects
  • Minimizes or eliminates potential compliance actions, costly penalties, and drug recalls
  • Offers opportunities for continual improvement

3. Quality by Design (QbD) provides more efficiency for regulatory oversight:

  • Streamlines post approval manufacturing changes and regulatory processes
  • More focused PAI and post approval cGMP inspections
  • Enhance opportunities for first cycle approval

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