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Abstract

PROCESS VALIDATION OF PIROXICAM DISPERSIBLE TABLETS

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

ABSTRACT

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

Keywords: prospective process validation, dispersible tablets, Control varibles.


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