Page 1 of 1
Revalidation and Robustness
Posted: Mon Jan 15, 2007 8:35 pm
by wanda50
I am evaluating revalidation of analytical methods >10 years old. Of course, we didn't consider robustness part of a validation at that time. Is this something we need to revisit, or can a response regarding philosophies at that time which felt ruggedness (namely Intermediate Precision) served to show that a method could be adequately used between diverse labs? I've read a bunch of stuff about current validations, but nothing about revalidations.
thanks!
Posted: Mon Jan 15, 2007 9:52 pm
by tom jupille
There is a version of "Murphy's Law" ("Sod's Law" for you UK folks) that goes: "
Once you open a can of worms, the only way to re-can them is to use a larger can."
If you have to revalidate, then it should be done right.
Validation and Robustness
Posted: Tue Jan 16, 2007 1:57 pm
by wanda50
Well, Tom, as usual you have confirmed my feelings. Those darn worms!
Thanks!
Posted: Tue Jan 16, 2007 3:04 pm
by Peter Apps
Wanda
On the vague off-chance that you have records of all the conditions that the analysis was run under, you can use them to argue that the method has already proved itself robust to the operational variations that have existed in practice.
Whether this will cut it with QC is another question ???????
Good luck !
Peter