Process Validation, Area and Equipment Qualification


Marketed By :  LAP LAMBERT Academic Publishing   Sold By :  Kamal Books International  
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  • Product Description

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.

Product Specifications
SKU :COC85083
Country of ManufactureIndia
Product BrandLAP LAMBERT Academic Publishing
Product Packaging InfoBox
In The Box1 Piece
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