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)