Process Characterization: Ready For The FDA?

By Greg Sears, Head of Manufacturing Science and Technology, Pharma Services, Biologics, Thermo Fisher Scientific

Prior to the 2011 release of the FDA guidance on process characterization,¹ the pharmaceutical industry historically viewed process characterization, the validation of a manufacturing process to minimize risk and ensure consistent quality throughout a product’s life cycle, as optional. As pipelines evolved to more complex molecules and manufacturing processes, though, the outlook of regulatory agencies on process characterization also changed. Today, they see process characterization as an essential step in the commercialization of a new drug product. This is related to various benefits of process characterization, such as enhancing not only process understanding but also, and most importantly, patient safety. Realizing these benefits and more requires proper planning and application of a comprehensive process characterization strategy.