Sale of product used in PQ

[Gialandon]

Hi,

I've been having discussion with our R&D and Sales teams recently. We are launching a new product and there is obviously a lot of excitement, sales are frothing at the mouth to sell it.
R&D have proposed that the batches manufactured for Performance Qualification be sold once all PQ activities are completed and if all batches pass QC/QA specifications.

I have not come across this before but Reg Affairs have no issue with this approach. Has anyone come across this before and are there any compliance issues with this approach?

 

[chris1price]

Yes, selling product made under PQ is a common approach, but only after all PQ runs are complete and the reports approved. Your R&D and RA appear to understand the requirements. Additionally, make sure all pre-production activities are completed, training, documentation, procedures, calibration, etc. These should be captured already if the validation has been done properly, but its worth double checking.