Abstract

PROCESS VALIDATION OF SOLID ORAL DOSAGE FORM OF TRANDOLAPRIL TABLET 1 MG

Monika Ola, Rajveer Bhaskar, Pratiksha Rathi and Lalita Chaudhari*

Abstract

The concept of validation was first proposed by Food and Drug Administration officials in 1970 in order to improve the quality of pharmaceuticals as well as different life saving products. Process validation is important to establish documented evidence which provides a high degree of assurance that a specific process for manufacturing of tablets will consistently produce a product meeting its pre-determined specifications and quality attributes. This study contributes to validation of all the steps while manufacturing of Trandolapril tablets. The different steps include in this study are, Sifting, Milling, Dry mixing, Granulation, Drying, Blending, Lubrication, compression, and Packing. While validation of all the steps different critical parameters were studied and found satisfactory as it fulfills acceptance criteria. We mainly focused on validation parameters like, Particle size distribution while sifting and milling, blend uniformity while blending and lubrication, LOD while drying, hardness, thickness, disintegration, dissolution, friability, average weight, group weight are studied after compression, Packing material were also checks for its quality. All results were found within acceptance limit.

Keywords: Solid Dosage form, Process Validation, Trandolapril Tablet, Quality management.