Products made during validation

I have a question about products which are made during valdiation.

My company is a medical device manufacturer, and typically our products pose low risk to patients (highest risk is a non sterile device). They are used externally for short periods only.

We have a validation system which does the IQ and OQ. After that we optimise where required to set control limits for things like temp, press etc. We then perform “worst case” testing during which we make products which we intensively sample for testing and inspection.

Then we do the PQ as per normal - 3 batches minimum etc.

Time after time, we get the same results in our testing during worst case running as we do in PQ. In other words, we meet the same acceptance criteria as we do in PQ, although we usually test at a higher frequency than during PQ.

At present, we discard all the product we make during the worst case runs. This seems to me to be very wasteful when we have lots of evidence that says there is no difference between that product, and what is then made at PQ.

My belief is that we discard it becuase it is standard industry practice to do so, and to explain otherwise to an auditor would require us to justify doing something which others don’t.

Are there any specific regulations for medical devices or validation which would absolutely prevent us from releasing product for sale if it’s made during the worst case challenge runs?

(To me it is obvious that releasing products made during worst case runs would only hapen if the whole validation was successful, and once any other conditions for release were met).


We had a client in a similar boat. They were advised by their regulatory consultant that they could sell the product but had to have controls in place to ensure that the product was quarantined until validation was complete. Of course, complete lot identification / traceability is still required.