Integrating Development Tools into the Process Validation Lifecycle to Achieve Six Sigma Pharmaceutical Quality

by Mark F. Witcher, PhD
Volume 17, Open Access (April 2018)

Achieving very high levels of pharmaceutical product quality, particularly for the next generation of biologics, will require proactive use of a broad range of quality and process development tools throughout the therapeutic‚Äôs development and manufacturing lifecycle. These tools are most effective when integrated using an expanded form of FDA‚Äôs 2011 process validation guidelines. This article explains how process validation can be combined with quality by design (QbD), ICH Q8 design space (DS) and control strategies (CS), process analytical technology (PAT), and quality risk management (QRM) tools to provide a path to manufacturing very high-quality products. The approach establishes clear goals and then proactively builds appropriate control systems during process development to assure continuous control and verification of all manufacturing activities. Prospectively using the tools over the complete manufacturing lifecycle, from preclinical through commercial manufacturing, is particularly important to assure comparability from early product research and development all the way to commercialization. The continued evolution of these quality tools, as well as building new tools, will provide a path for the pharmaceutical industry to reach and maintain Six Sigma levels of product quality…

Witcher MF. Integrating development tools into the process validation lifecycle to achieve six sigma pharmaceutical quality. BioProcess J, 2018; 17.

Posted online April 13, 2018.