We found out we have been using a equipment without validation for past 4 years

#1
As the title says, we found out we have been using a equipment without validation for past 4 years. It is very critical equipment that we use in GMP process. What would be our course of action now? We have used that machine frequently for last 4 years.
However, we have done regular quarterly calibration, yearly preventive maintenance and we do "day of use" calibration every time we use that equipment.

Can we do risk assessment now justify the previous years use and do new validation now for future use?

Please let me know your thoughts.
 
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yodon

Staff member
Super Moderator
#2
The typical path is to do a retrospective validation. Essentially, do a validation and then, as you note, do a risk assessment but also incorporate the validation data into the assessment to (hopefully) conclude product produced before meets spec.
 

Johnny Quality

Involved In Discussions
#3
Yaz,

What do you mean by "validation". What is the difference between your validation and your "day of use" calibration and quarterly calibration.

What do your procedures say? What's the risk?
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Sounds like a paperwork exercise at this point...
You have used it frequently for 4 years...{assuming} with no customer complaints tied to this process...I'd say it's validated on real world data right there. Document it, move on to something important.
 

yodon

Staff member
Super Moderator
#5
...no customer complaints tied to this process
No customer complaints does not necessarily mean product is in spec. The approach @Ninja describes may well suffice, though. I tend to see things through medical device colored glasses and that approach would not fly in that space. Probably a lot depends on whatever governs your industry.
 

Ninja

Looking for Reality
Trusted Information Resource
#7
No customer complaints does not necessarily mean product is in spec.
A fine point. I have assumed that, since the 4yr old issue was found and now concerns someone...that accuracy/effectiveness of measurement was already being addressed...best to check that assumption.
 
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