On Jan 15th, I posted "Who are your problem children?", in which I discussed our raw material ranking system to identify the materials we wanted to test first in our raw material characterization program (also described in more detail in previous posts).
Since then, we've been visiting customers and speaking to them about this program. And in the course of those discussions, we've shared our ranking criteria. In general, customers have said they agreed with the categories we were using to generate our ranking, however, some have expressed that they would have weighted the categories differently than we did.
I had not shared our weightings in my previous post. I thought that I would do so now and solicit feedback from the rest of the world as to how they might rank these factors.
It may help to comment that the quantity & purchase cost category is meant as a measure of the amount of that material we use, i.e. if we use more it could present higher risk. Sometimes purchase cost is easier to obtain than total amount in our systems - but it is essentially a surrogate quantity indicator.
Animal component free (ACF) status has generated conversation. Many have asked why it is not weighted more heavily by us. We had spirited discussion around that internally. Animal components, these days, tend to also be complex components (serum, hydrolysate, peptone). As such, we felt that we might be double counting if we weighted this parameter higher and also weighted complexity. Animal components also tend to confer more regulatory risk but that isn't necessarily what we're trying to measure here. We're really looking at performance variability in the component and that isn't necessarily driven by being animal or not. Certainly, that is an area that has drawn differing views.
I'd be interested to hear from the masses as to what you think.
Posted by Bruce Lehr Feb 9, 2010