Editor's Note: We are pleased to acknowledge that the source of this article's headline ("The Times They Are A-Changin' ") is the title of both a 1964 song by Bob Dylan and the album that featured said song.
I have been writing about PAT and QbD for some time, and I see two converging problems. First, there is a lack of communication between groups, job functions, companies, academic institutions and the like. Why should this be so in the age of the Web? It is well you should ask, my young apprentice (too many "Star Wars" movies).
Second, there is information overload. It was once postulated that Thomas Jefferson could have owned one of every book ever published. Not that Monticello was that big, but there were relatively few books in print at the time. Today, Jeffersons library would have to be larger than a domed stadium.
So not only do we have a failure to communicate, but a failure to digest the wall of information (or is it just data?).
What is a chemist/engineer/pharmacist to do? First, dont try to read everything. Then, go back in time, to the days when, if you wanted to buy a washing machine, you asked friends and family for their recommendations. Today, the closest thing we have to the old appliance recommendations are PAT and QbD conferences.
Ill be speaking at several such conferences this spring, both in Europe and the US of A. There will be talks by quality engineers, quality assurance officers, process engineers, statisticians, analytical chemists, and product development specialists, as well as some Agency folks from Europe and the U.S. Believe it or not, we are also seriously talking about the financial pressures for PAT and QbD.
Unfortunately, that is most of what we are doing: talking. While near-infrared is cited as the best-known technique being applied to PAT (I have personally used it for pharmaceuticals for over 25 years), how many universities actually teach it? After Duquesne, Kentucky, NC State, and Kansas State, I begin to falter and search for names. And how many hundreds of colleges and universities are there in the U.S. alone? Chemometrics comes off a little better; I know of a bunch of schools (still countable on two hands) that teach that subject, which is so critical to applying QbD and PAT.
So, we have an army (of teachers) fighting the last war (HPLC) while we are going to meetings, saying that we need to use multivariate calculations to understand critical points in our process stream. Don Dahm once said that science advances, one death at a time. Progress is made only when the old guard is replaced. I am encouraged that the movers and shakers of the industry have a firm grasp of the painfully obvious, but I believe the academic Maginot Line is pointed in the wrong direction.
Until and unless the academic community responds with 21st century curricula, we will have to fight (to paraphrase a recently defrocked Secretary of Defense) with the graduates we have, not the graduates we would like to have.
Heres a modest proposal: Why are we hung up on four years for a degree? This was based on the estimate of how long a British student would take to move from boyhood to manhood, not subject matter.
Engineering and Pharmacy schools have gone to five-year programs, so what would it hurt to tack on a year of process analysis to other programs? I think I was correct when I stated that all the thermodynamics and quantum mechanics I was forced to memorize would have little influence on my career. I would have done better to have a chemical engineering or electronics design option. Maybe the concept of a one size fits all cookie-cutter education needs to be re-evaluated, seriously.
But then, what do I know? My minors were in English and, later, in secondary education. I had to learn all my instrumental analysis from instrument companies and (gasp) experimentation which GMP discourages, but I beat that one up before, didnt I?