Please elaborate more between concurrent and prospective validation. Is it only related with final release of the batches for commercial use? And question two, do we need to specifically include the batch number on validation protocol or specifying number of batches is enough?

The major difference between prospective and concurrent is that when you prospectively validate,
you do not release the batches to the market until you have completed the validation project and
you’ve shown consistency of the process. Once you’ve shown consistency, then you can release
the batches. With concurrent, you haven’t shown consistency and you’re releasing the batches
through the market based on extensive testing. You won’t be able to show consistency until you
produce multiple batches, and that might take some time, maybe a year or two down the road.
Those batches are released during that time based on extensive testing.
Regarding the second question, whether or not you need to specify the batch number on the
validation protocol. No, the validation protocol normally includes the number of validation runs.
The batch numbers for validation will be specified in the validation report, not in the protocol.