Is it necessary that 3 batches must be taken for re qualification of a critical equipment like compression machine, RMG, Mass Mixer, FBD\FBP, coating pan and packing machine.
cant we take only one batch for re qualification purpose.
Generally, one batch will not indicate consistency in operation of equipment to give desired output or a product repeatedly. Hence, in order to prove consistent performance of equipment or machine at least 3 repeatative operations or batches should be manufactured.
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Its a traditional approach for requalification. Requalification should be based on the history of breakdowns, changes made on the equipment (refer change controls, changes in any of the critical parts of the equipment or modifications, etc), major or critical deviations wrt the equipment in question, any changes made WRT to utilities that are supplied to the equipment in question. Prepare a risk assessment report and check if the changes made calls for requalification. Some times as part of change control activities, the requirement of requalification will be decided. But still you will have to capture these details in the assessment. Based on the assessment, entire requalification may not be required. If required due to major changes, then you can perform using dummy batch. If the commercial product is used for requalification, then there can be chances of batch rejection due to unknown causes. But still you want to perform the requalification, then it should be based on risk assessment and can be performed on one batch.
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As the question was pertaining to requalification of CRITICAL equipment, it is always advisable to perform performance requalification on 3 repeatative operations or batches as the quality of output largely depends upon performance of critical equipment and machines.
In case of non-critical equipment based on risk assessment and breakdown history and other changes made in the equipment or machine one batch should be sufficient.
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