Handling and Managing of Vial Rejects

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dc.contributor.advisorNigaglioni, Rolando
dc.contributor.authorSantana Vargas, Gilmaris
dc.date.accessioned2022-03-31T15:16:56Z
dc.date.available2022-03-31T15:16:56Z
dc.date.issued2021
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractA large accumulation of filled vial rejects generated in an aseptic filling line of a parenteral medication was identified to be in the custody of the Quality Assurance department indefinitely. Using the DMAIC methodology the current vial handling practices and the batch records from the lots manufactured from 2019 until August 2021 were evaluated. Two (2) root causes were identified for storing all rejected filled vials indefinitely: (1) vials were needed for the visual inspection qualification defect library and (2) no formal procedure was established for the handling and management of rejected vials. New procedures were designed and implemented providing guidance on how to evaluate and onboard rejected filled vials to the defect library, or to discard the vials per waste regulations. The new implemented procedure allows for a compliant, easy to manage vial inventory and it supports the continuous updating of the defect library. Key Terms ⎯ DMAIC, Material Reclassification, Reject Management, Visual Inspectionen_US
dc.identifier.citationSantana Vargas, G. (2021) Handling and Managing of Vial Rejects [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1424
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.haspartSan Juanen_US
dc.relation.ispartofManufacturing Competitiveness Program;
dc.relation.ispartofseriesWinter-2021;
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US
dc.rights.licenseAll rights reserveden_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshSix sigma (Quality control standard)
dc.subject.lcshManufacturing processes--Quality control
dc.titleHandling and Managing of Vial Rejectsen_US
dc.typeArticleen_US

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