How do you call an impurity never seen before?
Impurity X is already taken, as it was the first one observed, and X is the most popular letter for unknowns.
Then came along impurities A, B and C- which were named one after the other, in the dreaded summer of 2017, where every Friday afternoon a new one was discovered in the accelerated stability study…
And now this one.
How do we call it?
Sure, we can always try to identify it, but that wouldn’t automatically give it a name (especially in Biologicals)…
How about using the RRT (Relative retention time)?
That’s an option, but go figure how it’s levels have changed over the years if the analytical method changes….
Fine- let’s just call it Impurity D and go on with our lives.
Just be careful when the next impurity comes up!
We don’t want to forget this one, and end up with two impurity D's...
(The above is based on a true story. Second Impurity D was corrected to Impurity E, but to this day, no one is sure if it was fixed in all documents).
I landed dozens of projects over the years.
The one thing in common is that there is nothing in common.
They all have their internal lingo to describe things.
From Impurity X to Equipment Y to Report Z.
This is understandable- each project is a unique snowflake, but the problem starts when the same things get different names and when the names evolve.
The veterans would know exactly why the name changed over the years and can jump back and forth, but what happens if they leave?
And how does the junior team member make something of it when writing that development report?
We were able to wing it so far, because we rely on Human intelligence, but in order to reap the benefits of Artificial Intelligence and LLMs, we (at least) must be sure to give things just one, unambiguous name and establish a common ontology for our projects.
Stay on top of the CMC development game and make smarter regulatory decisions- Subscribe.BeyondCMC.com
New around here? Take a free orientation to Drug Development and CMC here: Crashcourse.BeyondCMC.com