Chromatography Forum

Hi guys!

In my company procedure system we've must insert the periodical revalidation of analytical method. Every three years we must revalidate every analytical method.
But the term "revalidate" what it mean? What I must do? I must revalidate all method parameters? Linarity, accuracy ecc ecc?

Can you help me?

thank you!

Hi guys!

In my company procedure system we've must insert the periodical revalidation of analytical method. Every three years we must revalidate every analytical method.
But the term "revalidate" what it mean? What I must do? I must revalidate all method parameters? Linarity, accuracy ecc ecc?

Can you help me?

thank you!

Not being funny, but if your company has a procedure for periodical revalidation, it should have another SOP detailing what is needed to perform the revalidation. Talk to your boss or the QA dept.

We must still write this SOP. This is the reason of my question!
I want read your opinion about this.

I am not sure why they would revalidate a method every three years. Revalidation is required for a number of reasons, including change of run conditions, change of the sample formulation, etc. If nothing has changed there should be no reason to perform additional validation work.

Might be worth your time to find their reasoning behind revalidating every three years. I worked at a company for a while and they changed raw material suppliers and vendors as well as formulations so often that we really needed to revalidated every 6 months or so, but again, that was based on changes.

I agree with Paul just above, my opinion. There should be no need at all to revaidate the science, that doesn't change. If your API dissolved in methanol and absorbs UV light, that will be the same in 3 years or forever.

Do you test gravity every day?

Do you performance check your balance every day, and after each set of samples ?

Do you calibrate your pipets and volumetric flasks? Do you heat-dry them?

Is your lab 20C like the volumetric glassware states, or do you measure temperature (NIST thermometer, remeber, and make corrections?

Now, I'd say I could at least understand if your company had an SOP to do round-robin/operating testing (like Precision/Intermediate Precision tests) every three years. That would make a lot more sense. Ask them where this "revalidate" came from...bet they can't answer....

"Revalidate every three years? What the @#$% for?" would probably have been my response in that meeting, but then I'm not in management.


Wonder why?

"Revalidate every three years? What the @#$% for?" would probably have been my response in that meeting, but then I'm not in management.

Wonder why?

DR - that would have been my response exactly. It's amazing how many people in reality these days cannot handle - or feel threatened or abused by - a simple direct response.

So I 100% agree with you and CPG. And likely why I am no longer in management, and better the technical way.

Simply taking a method and revalidating it at an interval like 3 years isn't very helpful if you find a problem, where a method hasn't been changed. There's more of a move these days to trending performance checks (whether SSTs or regular PVs) with maybe some partial "revalidation" such as sensitivity checks etc. (unless these are already part of things like SSTs, in which case all the data is there waiting to be used), as linearity, range, precision won't have changed unless the instrument is misbehaving. I think this is maybe what you are looking for?

I wonder if you're a victim of terms. Many companys call their test methods SOPs, and require SOPs to be evaluated and re-issued on a periodic basis. Maybe if you explain the difference between evaluation and validation, and state that methods don't fit under the same rules as SOPs this could clarify matters.

I think it should not be revalidation, there is no logic in revalidating the method every three years.

Sir I'm totally agree with what you say. It's stupid to revalidate an analytical method every three years. But I must do it. In a future I'll hope that I'll can change this!

For now... I must revalidate all method charateristics! Accuracy, precision, ecc ecc. I'm sad!

Have a good day

Best regards!