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Applying a Quality Risk Management Approach to a Cleaning Validation System

dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorMedina, Jesús M.
dc.date.accessioned2020-09-28T11:35:31Z
dc.date.available2020-09-28T11:35:31Z
dc.date.issued2014
dc.identifier.citationMedina, J. M. (2014). Applying a quality risk management approach to a cleaning validation system [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/780
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractCleaning Validation is a crucial step on assuring product effectiveness and safety by assuring that the equipment to be used has the appropriate condition to manufacture a new product without any foreign substances that could endanger the patient to ingest this product. A quality risk management approach was used to see possible risks on a cleaning validation system and give recommendations in order to mitigate and control those the risks by seeking options to access does risks in an effective and reliable manner. FDA 21 CFR 210-211 was used as a guide for regulations regards cleaning validation systems. Key Terms - Cleaning Validation, FMEA, PAT, Quality Risk Management.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2014;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industry--Production standards
dc.subject.lcshPharmaceutical industry--Equipment and supplies--Cleaning
dc.subject.lcshPharmaceutical technology--Quality control
dc.subject.lcshRisk management
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleApplying a Quality Risk Management Approach to a Cleaning Validation Systemen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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