Rodolfo J. Romanach

The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.

Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.