Process Validation of Oral Solid Dosage Form-Tablet containing Anti Tubercular Agent

Abstract

The purpose of study is to validate process of Rifampin 150mg and Isoniazid 75mg tablet and to create a robust formulation. The critical process parameter was identified with the help of optimization batches of process capability and evaluated by challenging specification. Three process validation batches of same size, manufacturing process, equipment & 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.