REPROCESS AND REWORK

REPROCESS AND REWORK :

 REPROCESS:
Any active pharmaceutical ingredients, intermediates or key starting materials that fail to meet the specifications, back into the process by repeating a crystallization step or other appropriate chemical or physical manipulation steps that are part of the established manufacturing process.

REWORK:
When a failing batch cannot be purified using the established manufacturing process, R & D works out to the specific requirement and develops the method for purifying the batch. When the failed batch is processed using one or more processing steps, which are different from established manufacturing process shall be considered as rework.

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