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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorValerín Díaz, Melissa
dc.date.accessioned2020-12-16T15:30:39Z
dc.date.available2020-12-16T15:30:39Z
dc.date.issued2019
dc.identifier.citationValerín Díaz, M. (2019). Alternate raw material supplier validation [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1007
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThis 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.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesWinter-2019;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshRaw materials
dc.subject.lcshIbuprofen
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleAlternate Raw Material Supplier Validationen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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