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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorBenjamin Rodríguez, Amarilys
dc.date.accessioned2020-09-16T18:13:54Z
dc.date.available2020-09-16T18:13:54Z
dc.date.issued2015
dc.identifier.citationBenjamin Rodríguez, A. (2015). Quality risk management (QRM) considerations for introduction of new products [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/645
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractQuality Risk Management (QRM) is an optional tool to improve product effectiveness and safety by assuring that the recognized risk is at a desired level. Also risk management tools provide a methodology to evaluate risk levels and prioritize on risk mitigation and risk control strategies. For this design project an evaluation was performed to identify the factors and considerations that could be adopted from the QRM methodology during the technology transfer process and new product introductions. The technology transfer approach was used to see possible risks and take on preventive actions to mitigate risk and avoid to inherit the risks throughout product life cycle. ICH Q9 was used as a guide for risk assessment during a pilot program on whole to ICH Q10 Pharmaceutical Quality System. An evaluation was conducted by determining risk prioritization numbers during the different new product introduction stages. It was noticed that as the new product introduction process progressed closer to commercial manufacturing, launch and distribution, the risk decreased which was a result of increased process detectability and reduced occurrence. Key Terms- FMEA, New Products, Quality Risk Management, RPN, Technology Transferen_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2015;
dc.relation.haspartSan Juanen_US
dc.subject.lcshRisk management
dc.subject.lcshPharmaceutical biotechnology industry--Quality control
dc.subject.lcshPharmaceutical technology--Equipment and supplies
dc.subject.lcshPharmaceutical technology--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleQuality Risk Management (QRM) Considerations for Introduction of New Productsen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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