Process validation

how to handle deviation of process parameters in process validation batches

Please investigate the deviations and find out root cause(s). Take appropriate actions to rectify the process,may be re-designing the formulation or process parameters based on the root cause identified.
If the deviation is due to operator error then re-train the operator and do councelling.
In that case please consider for re-validation of process. Document the entire event.

Your validation protocol should provide guidelines to investigate any deviation during the validation process. In principle, you should apply the same procedure as any formal investigation to detetmine root cause. The investigation’s output should be well documented, approved by QA to determine if the validation study is acceptable, or not. Any investigation should be included in the validation package and be available during an audit or inspection process.


Ideally, There must be no deviations on the process procedures and parameters in the BMR for the three consecutive batches that will be subjected for process validation. If deviations or changes occur, it should not be critical to the process. If the deviations are critical, the validation team will conducted further study before proceeding for process validation.

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