How Does The FDA's Process Validation Guidance Simplify A Technology Transfer?

By Norm Fong, technical transfer manager, business development, WellSpring

The technology transfer of a process, whether it is from R&D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product. To ensure your manufacturing site is doing what it should, it will help you to become familiar with the FDA’s process validation (PV) guidance, issued in January 2011, which defines three major stages that must be satisfied to consider a manufacturing process valid.