Emil W. Ciurczak wrote a nice blog post for PharmaEvolution claiming that the weak link in QbD is a lack of adequately trained chemometricians. I enjoyed his article, Chemometrics: The Weak Link in QbD, and I agree wholeheartedly with the conclusion that “the need for correct and in-depth chemometrics training is necessary for a successful PAT program.” But I don’t see how this is reconciled with “The title and spirit of this brief educational brochure from one vendor are right on target.” Anything that is “For Dummies” almost surely cannot be “in-depth.” And while I applaud the vendor for coming up with the concept, (and I’d say I wish we’d thought of it except we did think of it and the result is our CWE-Chemometrics without Equations courses) there isn’t much real information in the brochure. For instance Chapter 4 on classification is just 3 pages, one of which is just a list of applications.
The fact that chemometrics remains the weak link iin QbD is disappointing but it certainly isn’t for lack of effort on our part. We’ve taught hundreds of classes and thousands of students but a fairly small fraction of those are from pharma. From our business point-of-view, but also as a consumer of pharma products, I’d be happy to see more effort go into developing staff with chemometrics expertise. I do appreciate that it is, for many people, rather challenging subject material. We have put great effort into making chemometrics accessible. But I resist the urge to dumb it down too much.
An often used analogy is that most people don’t know how their mobile phone works but they are still able to use it, and chemometrics should be just as easy. But, unlike cell phones, chemometric tools aren’t being used by consumers, they are part of the process for producing things like mobile phones. And drugs. As such, their use and misuse has consequences. And while I’m happy to introduce people to chemometrics with our CWE courses and think attendees gain a useful level of proficiency and understanding of the techniques involved, I would prefer that those involved in QbD and pharma manufacturing acquire a deeper level of mastery. (To this end we provide our Eigenvector University courses, the next instance of which is EigenU Europe this October.) In order to understand a system’s limitations and how it can fail, you really need to understand how it works. You’re not going to get that at the “Dummies” level.
I very much appreciate Emil’s continued efforts to enlighten pharma as to the critical role of chemometrics. But, like me, does he sometimes feel as though he is pushing a string? I was struck by the registration process for PharmaEvolution website when you had to select your company’s business. There was a very long list of possibilities, but the closest thing to what we do was the very generic selection “engineering.” I still get the feeling that many in pharma (and certainly in some other industries) think of chemometrics as something that you do AFTER you’ve decided everything else and have started to take data. Thank-you, Emil, for your efforts to make it the integral part of the system that it must become.
BMW
