On of my actions that have came out of a recent audit was to document the periodic review of the validation that have taken place with regards to processes and equipment.

Does anybody have any documetns that I could use as a starting point.

Thanks in advance

What we do is conduct a "mini-validation" to demonstrate, with smaller samples and batches, that the same inputs produce the same outputs as in the original validation. Thus the validation review follows the format of the validation, but in condensed form.

I go with your term "Review".

There is a distinct difference between "Retrospective Review" and "Retrospective Validation" and feel that your proposal of Review falls under "Retrospective Review".

This could be initaited by writing a retrospective review protocol first. This review can be done by using statistical techniques to review the data of products that have been manufactured using a validated process.

I am quite not in favor of MIREGMGR proposal mainly with the fear of failure. If the "mini validation", the previous validation is questionable and the disposition of the released batches would be a big issue as they have to be recalled / acted upon.

I am quite not in favor of MIREGMGR proposal mainly with the fear of failure. If the "mini validation", the previous validation is questionable and the disposition of the released batches would be a big issue as they have to be recalled / acted upon.

Yes, but that's exactly the proof-requirement/business risk that our OEM medical-device customers expect us to expose ourselves to, in order to retain their business. They insist that our validations not be "questionable", and that we be able to repeatedly prove that status.

Ultimately for us, this approach is driven by our marketing desire to have those customers.

Yes, but that's exactly the proof-requirement/business risk that our OEM medical-device customers expect us to expose ourselves to, in order to retain their business. They insist that our validations not be "questionable", and that we be able to repeatedly prove that status.

Ultimately for us, this approach is driven by our marketing desire to have those customers.

Oh, then no choice for you :)

In some of the previous Pharma companies that I worked, we did a retrospective review and was fine with the regulators.