Process validation perform for 3 batches during at time why two different vendor API not used what’s reason?
I general during the process validation, only single source of vendor to be considered for validate the process.
If you take 2 batches with one vendor material and third one with different vendor. There may be chances of variation in quality of output, either it is physical or chemical property.
Because the manufacturing process of input materials may be different from each other…so it may leads to variation in quality of the validation batches.
In another point of view, we can justify the we can justify the above subjected question as follows…
Process validation batches should be carried out by applying/using the same source of materials and process parameters and equipments. Finally the batches output should meet the criteria of “CCC”.
i.e; C-confirmation to the specifications.
C-Coincidence within the batches.
C-Completion of validation without any deviations.
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Thank you for valuable information
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