Process Validation Area and Equipment Qualification

Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD RMG Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment qualification of area equipment water and air was carried out as per qualification protocol. Now further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation one standardization batch was taken where the process optimization of critical parameter like mixing speed mixing time lubrication time was carried out; fast 15 min 15 min respectively the results for that. Three process validation batches (PV-1 PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process critical parameters Validation status of equipments & Validation criteria's were considered.