Managing QbD From A CMO Perspective

By Stephen A. Munk, Ph.D., President and CEO, Ash Stevens, Inc.

The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

Although the FDA and EMA have not mandated that QbD be applied in the manufacture of therapeutic products, the agencies have clearly embraced the approach as part of their efforts to encourage modernization in biopharmaceutical manufacturing and obtain greater assurance that therapeutic agents meet quality and safety standards. The FDA, EMA, and the International Committee on Harmonization (ICH) have issued regulatory guidance on QbD-based manufacturing of active pharmaceutical ingredients (APIs).