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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorRivera, José Orlando
dc.contributor.authorArizmendi Figueroa, Rose Mary
dc.date.accessioned2020-10-13T14:55:22Z
dc.date.available2020-10-13T14:55:22Z
dc.date.issued2008
dc.identifier.citationArizmendi Figueroa, R. M. (2008). Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.
dc.identifier.urihttp://hdl.handle.net/20.500.12475/841
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be clean prior to its use for manufacturing, processing, packing, holding of a drug product and/ or when sampling a raw material. Currently, some pharmaceutical plants have failed to design a good manual cleaning process. In regards to this, the Management Theory is crucial to manage effectively a cleaning procedure with the optimization of the Cleaning Process Validation. The application of the management functions contributed on the development of a guide to correct these faults and/or prevent further occurrence. By implementing the Administrative Management Theory a cleaning validation program is without a doubt optimized. Key Terms — Administrative Management Theory, Cleaning validation, crucial, optimizationen_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness Program;
dc.relation.ispartofseriesFall-2008;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industry--Management
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshDrug factories--Equipment and supplies--Cleaning
dc.subject.lcshMedical instruments and apparatus--Sterilization
dc.subject.lcshPharmaceutical technology--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleAre cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical planten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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