Process validation

we have different batch size of one product . explain the Bracketing process for process validation.

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Risk factors higher in big size batches, hence you have to take highest sized batch for better

Perform risk assessment to determine the worst case batch size(s). might very well be both smallest and largest batch size. Validate both batch sizes (3x each) and in your validation report state that all batch sizes in between are validated also (assuming the production process is the same for all batch sizes).

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