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All through this phase, steady monitoring of process parameters and top quality characteristics at the level recognized during the process validation stage shall be performed.Accumulate the samples as per sampling prepare outlined inside the PV protocol & tested in QC and PV staff shall attain the outcome to compiled for evaluation with the PV team
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Ans: A deviation can be an unexpected party that accrues for the duration of the continued operation/ activity/ Documentation/ entries at any phase of receipt, storage and Manufacturing, Investigation and distribution of drugs products and solutions/Intermediate/Uncooked elements/ packing resources. The deviation would be to be documented as and wh