Can we sell units that were chosen for process validation?

[snoopy2017]

Hi everyone,

My company does not have much experience with process validation, and I am seeking some help. Can we sell units that were chosen for process validation? We have completed validation on a few units; can we still sell the units?

Thanks.

 

[stacig]

Hi snoopy2017,

Are you referring to the units as the item that is manufactured from the process you are trying to validate? If so, are they FDA regulated units?

 

[snoopy2017]

Yes. The units are manufactured from the process we are trying to validate.

 

[Candi1024]

As long as none of the testing was destructive or reduce the quality of the product, for example accelerating aging, I would say, in general, you can ship.

 

[ScottK]

As yourself 2 questions:
1) Are you required by procedure or regulation to keep some or all of your validation parts as evidence?
2) Do they meet all specifications?

If you don't have to keep the parts as evidence AND they meet specifications then sure, you can sell them.

I've used validation components is final product in the Med Device World (class 1 exempt).

 

[yodon]

ScottK is spot-on in his response. Just to add a bit more, were they stored and handled in a manner that would not compromise the safety or effectiveness? Is there no way they were mixed up with units not meeting spec?

 

[Ajit Basrur]

Hi everyone,

My company does not have much experience with process validation, and I am seeking some help. Can we sell units that were chosen for process validation? We have completed validation on a few units; can we still sell the units?

Thanks.

In addition to the earlier responses, I would say that the PQ of the Process Validation could be sold commercially post approval of the successful Process Validation report.

Did you describe this aspect in your Process validation protocol? If you are a contract manufacturer, is your customer in agreement?