The Desired State: PAT and the Road to Enlightenment

By Ajaz S. Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER, the U.S. Food and Drug Administration (FDA)
PharmaManufacturing.com
By focusing on the pharmaceutical manufacturing process, ASTM standards for process analytical technology (PAT) promise to bring engineering rigor and proactive decisionmaking to pharmaceutical quality.
Process understanding can be a foundation for innovation and continuous improvement in pharmaceutical development and manufacturing. FDA’s Process Analytical Technology (PAT) initiative, part of the Agency’s 21st Century cGMPs [1-5], reaffirms that message [5-7], but also aims to help the global pharmaceutical community reach a “desired state,” where:
Product quality and performance are achieved and assured by design of effective and efficient manufacturing processes;
Product specifications are based on a mechanistic understanding of how formulation and process factors impact product performance;
Manufacturers are able to effect continuous improvement and continuous "real time" assurance of quality. The phrase “desired state” was first articulated two years ago, at the International Conference on Harmonization (ICH) in Brussels, where the idea of a global, harmonized pharmaceutical quality system began to take shape. The system would be based on science and applicable across a product’s life cycle. First, however, the pharmaceutical community would have to overcome the hurdles—historical, traditional, and cultural—that have prevented it from reaching this nirvana.

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