Why do we consider three consecutive runs/batches for process validation? Why not two or four?

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The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.

·       First batch quality is accidental (co-incidental),
·       Second batch quality is regular (accidental),
·       Third batch quality is validation (confirmation).


In 2 batches we cannot assure the reproducibility of data, 4 batches can be taken but the time and cost are involved.


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