Can anyone please provide me what exactly is the Validation Strategy during the commercial run. Like exactly on what basis we have to look into to validate the batches. Is it like based on the batch size/complexity etc. For example how many lots should we validate to move forward with the normal production run?
we have to take 3 batches for the validation of a process in order to get the accurate and precise results. After completion of three batches one can justify the accuracy of results and after getting all the parameters limits we can fix the parameters for future production run.
hope u got the answer