Process Analytical Technology: A First-Birthday Standardization Update

The author describes the efforts of the standards committees to establish guidelines for Process analytical technology (PAT) implementation and the impact of the guidelines o­n the industry.

Introducing process analytical technology (PAT) has been like delivering a baby, with proud parents (the standard - set ting bodies , led by the US Food and Drug Administrati on’s dep uty director of ph a rm aceutical science, Ajaz Hussain), a r g u m ents over the name (several were con s i dered before s ettling on P-A-T, alw ays pronounced letter- by - letter ) , baby showers (the series of advisory committee meetings and draft p u bl i c a ti ons through 2002 and early 2003), and a bi rth (publication of the FDA draft guidance, weighing in at 21 pages, on 3 September 2003). Since then, there have been ups and downs, sleepless nights, exciting firsts, and countless adjustments to a new way of life. PAT has taken its first steps, and most, if not all, of the Top 20 pharmaceutical firms have active PAT programs.