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Paper Details


R.N.Rajput*, R.D.Wagh, R.L.Shirole, N.L.Shirole

Journal Title:World Journal of Pharmaceutical Research

The purpose of the research investigation was to study prospective process validation of Dispersible tablet dosage form. Quality cannot be adequately assured by in process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications. Therefore building of quality requires careful attention to a number of factors, such as the selection of materials, product and process design, control variables in process Control and finished product testing. The critical process parameters were identified with the help of process capability and evaluated by challenging its lower and upper release specifications. Three initial process validation batches of same size, method, equipment & validation criteria were taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication & compression stages were identified and evaluated as per validation plan.