Process Validation of Benazepril HCl 5 mg Tablet

Abstract

The purpose of research was to study prospective process validation Benazepril HCl 5 mg tablet dosage formulation. The critical process parameter was identified with the help of process capability and evaluated by challenging its lower & upper release specification. One initial process validation batches size, method, equipment & validation criteria were taken. The critical parameter involved in sifting, Blending ,compression stages were identified and evaluated as per validation master plan. 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.