Validation & REvalidation

[valtschaq]

Hello again,

A few years ago I was struggling with retrospective validation of our products.
Some time later I started to work on concurrent validation.
Now it is time to revise these validation reports and that’s where my question arise:

If I run concurrent validation on a product that has been validated retrospectively, should I call it RE-validation?

I was quite sure that this is REvalidation, furthermore - that this is just our internal, formal issue.
However our Registration Section claims that this “re-” prefix is of some great significance

(The same problem with concurrent -> prospective validation)

Thanx in advance.

[Alfred]

Dear valtschaq,

in my opinion there is no re-validation possible, regardless if the validation was retrospective or not. If the process has not changed over time, and you can prove it, it is still valid. If it has changed, it is a validation of a new process and not a revalidation. As to my knowledge the FDA does not use the term “revalidation” but “keep in a validated state” through statistical evaluation of process data.

Best regards

Alfred