dc.rights.license | All rights reserved | en_US |
dc.contributor.advisor | Rivera, José Orlando | |
dc.contributor.author | Arizmendi Figueroa, Rose Mary | |
dc.date.accessioned | 2020-10-13T14:55:22Z | |
dc.date.available | 2020-10-13T14:55:22Z | |
dc.date.issued | 2008 | |
dc.identifier.citation | Arizmendi 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faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant [Unpublished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.uri | http://hdl.handle.net/20.500.12475/841 | |
dc.description | Design Project Article for the Graduate
Programs at Polytechnic University of
Puerto Rico | en_US |
dc.description.abstract | The 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, optimization | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Polytechnic University of Puerto Rico | en_US |
dc.relation.ispartof | Manufacturing Competitiveness Program; | |
dc.relation.ispartofseries | Fall-2008; | |
dc.relation.haspart | San Juan | en_US |
dc.subject.lcsh | Pharmaceutical industry--Management | |
dc.subject.lcsh | Pharmaceutical industry--Quality control | |
dc.subject.lcsh | Drug factories--Equipment and supplies--Cleaning | |
dc.subject.lcsh | Medical instruments and apparatus--Sterilization | |
dc.subject.lcsh | Pharmaceutical technology--Quality control | |
dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Research | |
dc.title | Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant | en_US |
dc.type | Article | en_US |
dc.rights.holder | Polytechnic University of Puerto Rico,
Graduate School | en_US |