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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorPérez Moyeno, Janet
dc.date.accessioned2020-11-10T16:20:42Z
dc.date.available2020-11-10T16:20:42Z
dc.date.issued2009
dc.identifier.citationPérez Moyeno, J. (2009). Development of general guidelines for the pharmaceutical manufacture company reaction to a consent decree emitted by the Federal Drug Administration (FDA) [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/936
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; and, it will involve the company re-constitute the manufacturing practices to bring it in alignment with the Food and Drug Administration (FDA’s) Good Manufacturing Practices. This project main purpose is to give guides on how pharmaceutical industries should react when a Consent Decree is given. Based on all information gathered from different sources, the consequences that bring the consent decree, the review of FDA inspectional process, and the hints required to effectively interact with the FDA are given. Finally, the guide will assist the companies to manage important events regarding compliance with the Good Manufacturing Practices and with the requisites of the consent decree. Key Terms ⎯ cGMP, consent decree, FDA inspections, regulatory issues, warning letters.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Compretitiveness;
dc.relation.ispartofseriesSpring-2009;
dc.relation.haspartSan Juanen_US
dc.subject.lcshConsent decreesen_US
dc.subject.lcshPharmaceutical industry--Quality controlen_US
dc.subject.lcshDrugs--Standards--United Statesen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleDevelopment of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)en_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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