Abstract

PROCESS VALIDATION OF METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS USP 500MG

P.S. Shewale*,V.A.Jagtap, A.A.Varade , V.L.Badgujar

Abstract

Process Validation is a reqirement of the cGMP regulations for the finished pharmaceuticals. Purpose of research was to study Process Validation of Metformin HCL 500mg tablets dosage formulation, which acts as a type 2 diabetes. Three initial process validation batches (MF2001, MF2002 & MF3001) of same size, method, equipment & validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication & 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.

Keywords: cGMP, process validation, MF, HCL.