PROCESS VALIDATION OF METFORMIN HYDROCHLORIDE AND GLIMEPIRIDE BILAYERED EXTENDED RELEASE TABLET

Quality cannot be adequately assured by in-process and finished product testing. But it should be built into the various stages of manufacturing process. These manufacturing processes with various manufacturing steps including various critical process parameters should be controlled in order to obtain finished product which meets all the quality specifications. The critical process parameters were identified and evaluated by performing various tests at different stages. Three process validation batches of same size, method, equipment and validation criteria were taken. The critical parameters involved in sifting, granulation (dry mixing, wet mixing, drying, milling, lubrication), precompression and compression were identified and evaluated. Different stages of manufacturing process were evaluated for acceptable granulation process and moisture content of granules after granulation; acceptable moisture content after drying; acceptable particle size distribution, blend uniformity, bulk density after lubrication; weight variation, thickness, hardness, % friability, dissolution, disintegration after compression. 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. So, manufacturing process of Metformin HCl and Glimepiride bilayer tablet was considered as validated.