Alternate Raw Material Supplier Validation

Abstract

This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed that they have not recovered from a natural disaster that impacted their facilities. As a result of this natural disaster, the supplier shut down production of ibuprofen indefinitely. In order to alleviate ibuprofen drug shortage imposed by primary supplier’s facility shut down, GSK Puerto Rico has identified potential alternate supplier of Ibuprofen for the current Ibuprofen OTC products. To conduct this project, DMAIC methodology was used in order to have a better understanding of the process to increase efficacy and identify areas of opportunity to improve. GSK Puerto Rico is responsible for the 100% of the Ibuprofen family products for US domestic sales and Ibuprofen family represents 58% of GSK 2019 volume plan. The company will be able to supply the expected volume of Ibuprofen family products to the customers and the volume plan will be achieved with the validation of alternate ibuprofen supplier for Ibuprofen family products.

Key Terms - DMAIC, Process Validation, Raw Material, Supplier Qualification.