Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative

The initiative taken by the FDA on the use of process analytical technologies (PAT) in the pharmaceutical industry is discussed. Analytical tools have evolved to such an extent that they are capable of dealing with the complex matrix of multiple dosage forms and of providing data in meaningful way. In the process, near-infrared spectroscopy (NIR), radio frequency, and microwaves have been applied for moisture determination. The first PAT team will, continue its training, and a second PAT team will be selected to begin training for CMC review and cGMP inspections of applications that utilize PAT.