Process Validation of Solid Oral Dosage Form of Ethambutol.HCl and Isoniazid Combination Tablet

Abstract

The current study was designed to meet the current regulatory requirements and prove with assurance that, the product meets the predetermined specifications and quality attributes. The objective of the study was to systematically conduct the validation studies pertaining to the manufacturing activities of solid oral dosage form of tablet and to confirm that the product manufactured with the present method consistently meets the predetermined specifications and quality attributes. Concurrent process validation of manufacturing process of Ethambutol.HCl 800 mg and Isoniazid 300 mg combination tablet was being undertaken due to the addition of “Wet Milling” step for wet granulation. The purpose is to develop a proper design and a robust process along with tests for appropriate quality control checks which will lead to high quality product. Hence, the present work was carried out on the process validation of solid oral dosage form of the tablets. Present work was carried out on the process validation of solid oral dosage form of the tablets confirms that the observed sets of conditions are better suited for manufacturing.