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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Miranda, Carlos J.
dc.contributor.authorMadera, Juan Carlos
dc.date.accessioned2020-12-15T13:44:44Z
dc.date.available2020-12-15T13:44:44Z
dc.date.issued2010
dc.identifier.citationMadera, J. C. (2010). Structured approach for compliance determination of FDA regulated tablet compression process [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/993
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractTablets are the most popular unit dosage form used by the Pharmaceutical Industry to provide health treatment to patients in the United States. It is important to control process critical parameters (variables) such as weight, thickness and hardness of the unit dosage form to provide the patient with the same drug levels obtained during clinical studies. There are also quality attributes that are inherent to product quality such as shape, color, texture, and general appearance. Without robust in-process controls, it is very likely to have undesired effects such as manufacturing yield issues, rework or re-processing, customer complaints, and possible observations from regulatory agencies that may affect not only economically but also the company quality reputation. For this reason it was developed a comprehensive method, structured to help as a guideline to understand the current level of compliance for pharmaceutical tablet compression facilities regulated by the FDA. Key Terms - cGMP, process controls, recall, tablet compression.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2010;
dc.relation.haspartSan Juanen_US
dc.subject.lcshCyclic guanylic aciden_US
dc.subject.lcshProcess control
dc.subject.lcshTablets (Medicine)
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleStructured Approach for Compliance Determination of FDA Regulated Tablet Compression Processen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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