Root Cause for a Process Validation Batch Failure

P

PVMRS

#1
if the root cause for a process validation batch failure of nth stage is a critical material attribute of previous intermediate (n-1 stage) and there is no process modification in nth stage is required as a corrective action (specification tightening of n-1 stage is required to prevent the failure), will the nth stage process validation considered as complete or need to repeat the nth stage validation?
 
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#2
Maybe. Depending on the type of industry you are in it may or may not be allowed. From a scientific point of view I would say it could be possible to gain enough data from the validation batch and show that the process meet the requirements stated in the validation protocol even though the actual batch did not make the cut so to speak. What speaks against it might be the rational you have for the number of validation batches you have choosen to make. If you do not have that amount of batches to show repeatability can you still make a case that the process is reproducible at the needed level of confidence? Further more I would guess that you need to have a very strong case that the root cause has been found and that the effects on the validation batch is well known and can be neglected when reviewing the data from the validation batch.

If you are in the pharmacetical buisness and adhere to FDA regulation you can read the guidance for industry on process validation to get guidance. They do not specificly state that a failed batch is a failed validation but rather that all deviationas shoud be evaluated and taken into concideration when evaluating the results from the validation activites and based on that the verdict whether to approve of fail the validation should be formed. I would guess that approach would be suitable in other areas too unless regulations state otherwise.
 
P

PVMRS

#3
Thanks Franco for your reply. Yes it is in pharma related question. As a general practice, we have executed 3 validation batches and one got failed. Root cause was CMA of previous stage. CAPA was implemented at n-1 stage by tightening the specification.

In my view as the failure is due to extrinsic factor (though process does not require modification), we can add one addendum batch for showing consistency in the process. But how FDA will consider acceptance of this validation if we do not add addendum batch to the PV Report.
 
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