Brian Stephens, a life sciences consultant for ABB INC, addressed the Interphex 2008 attendees this morning in a discussion about process analytical technology (PAT). He threw out the “learn, predict, control” phrase industry has latched onto as an easier way to define PAT, which is essentially a tool or system for implementing QbD that involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs), and then figuring out the best way to measure the CQAs in order to control the CPPs.
Stephens went on to describe how some 60 FDA investigators are undergoing PAT training this year so they can be better prepared for inspections (and ideally avoid a repeat of the validation inspection process of the 1980s and early 1990s when computer validation came into play). (I find it quite strange, by the way, that FDA has been rolling out and pushing PAT initiatives while still learning about it themselves. Seems like the order of things here is somewhat backward.)
Anyway, Stephens’ presentation focused on the benefits of PAT which ultimately come down to a company’s return on investment. Production life cycle time might be reduced by 40%, he said, with PAT applications. Multi-instrumentation might reduce process cycle time by 50%, electronic storage of information might reduce QA costs by 15%, and yield might increase with the help of design space and getting manufacturing right “the first time.” In addition, companies might be able to save millions of dollars by implementing PAT. For example, said Stephens, a $10b company that improves its efficiency by even just 1% can ultimately save $25m a year.
But what can’t companies bank on? “Regulatory relief.” The two little words FDA began throwing around when talks of QbD and PAT became mainstream. Those two little words soon transformed into “regulatory flexibility.” And now even those are heading out the door. It seems, from what I’ve heard in tidbits here and there at Interphex, that FDA needs to treat companies implementing QbD on a case-by-case basis. There won’t be a formal agreement or guideline coming anytime soon (or probably ever) that outlines the regulatory “relief” or “flexibility” that companies can expect. While cleaner audit trails and processes may make inspections smoother or quicker, points out Stephens, companies looking to start up PAT in their manufacturing units should probably focus on how they can save money with PAT, not get out of FDA oversight.