Revalidation and Robustness

[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!

[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.

[wanda50]

Well, Tom, as usual you have confirmed my feelings. Those darn worms!

Thanks!

[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