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Process Validation of Bisoprolol Fumarate 3.75 mg Film-coated Tablets

Pooja Gona, Hitakshi Machhi, Muskanbanu Shaikh, Preeti Shahi, Saurabhkumar Patel, Parixit Prajapati

Abstract


The word validation simply means assessment of validity or action of proving effectiveness. Although validation does not in and of itself improve processes, it does ensure that they have been established correctly and are in compliance. Process validation is the process of validating each individual step. One may be sure that the final product will be of the highest quality if every stage of the production process is evaluated. Process validation of for three consecutive batches Bisoprolol Fumarate 3.75 mg Film-coated Tablets was carried out. In the present work, all the individual processes like sifting, blending, lubrication, compression, coating and packaging were fully monitored and samples were collected according to the sampling plan. All the in-process parameters and process variables were checked and found well within the limit. Results of the validation data suggested that no significant variation between batch to batch was found and the production procedure reliably resulted in a stable product that met the required specifications and quality standards.


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