Agree with this in terms of having an established amount of lots, units, and time for running the validation. If you are conducting a validation you would want to prove that a set amount of lots or units is sufficient in proving the output equals the input. You run these trials during the Operational Qualification and Performance Qualification of the validation. The Performance Qualification is key just because you need to prove that production lots or units are producing the intended outputs. Most of the time these lots and units will actually be shipped to customers. Therefore, it is highly important to ensure that you are validation is indeed sufficient in terms of the # of lots or units you are testing and that these products meet the criteria.