What if you were doing a process validation for a liquid OTC product BUT you only make the product once every six months.
Can you sell/distribute the first batch providing your lab/micro passed? -Even though you have not yet executed the next two validation batches.
After reading on this site that three consecutive batches is NOT required, (optional) what justification/rationale can be used to release the first batch for production/distribution? (when you have nothing to compare it to except small pilot batches)
The final decision to distribute/sell the product only with the lab/micro results without having ready the other two validation batches would have to go to your Quality responsible.
In the past we have supported the release with only one batch based on cost of production, inventory and sales and providing the total quantity of product that would go to the trash (normally because of expiration issues) and how would this impact finantially to the company.
In this case you would be performing concurrent validation.