The Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives have been gaining momentum within the regulated industries as a way to better understand and improve critical manufacturing processes, resulting in higher quality drug products. The overall result being improved public safety and decreased manufacturing costs.

Fundamental to PAT & QbD are the data analysis tools provided by DoE and MVA.
The Unscrambler® GenX ( Generation X ) family of products were designed with PAT & QbD in mind. Applications such as formulation development, process validation and improvement represent excellent application areas for The Unscrambler® and the new Unscrambler Online is set to provide industries with the most flexible and adaptable, custom solution to real time process monitoring and improvement.

The Unscrambler® GenX family of products can be used to define, understand and maintain the Design Space of a process and ensure that the Desired State is always maintained.

The following describes the PAT & QbD initiatives from a regulatory and practical point of view and show how
The Unscrambler® GenX family of products fits into the key stages of a PAT/QbD project, from the beginning right through to real time monitoring.