Process Validation of Isoniazide and Rifampin Tablet

Abstract

The plethora subscribed in this research is directed towards the process validation of tablet formulation containing Isoniazide and Rifampin. The different process parameters were identified and studied for the tablet formulation batches. Three process validation batches of same size, manufacturing process, equipment and validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.