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dc.rights.licenseAll rights licenseen_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorRivera Ramos, Carol G.
dc.date.accessioned2020-09-16T15:34:38Z
dc.date.available2020-09-16T15:34:38Z
dc.date.issued2015
dc.identifier.citationRivera Ramos, C. G. (2015). Enhancement of batch review report for annual product reviews in the pharmaceutical industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/609
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe pharmaceutical industry is required to comply with various regulatory agencies which determine the industry capabilities for compliance and allow the marketing of their products. Regardless the regulatory agency one requirement that is common is the review of the batches that are manufactured and packaged, whether approved or rejected. The current process used to determine the batch status is delaying the process for the report submission. The project objectives were to reduce the cycle time along with an enhancement in the information provided within it. The Lean Six Sigma methodology, specifically the DMAIC tool, was used to accomplish these objectives. After a thorough review of the possible root causes it was determined that a new system to search the batches status was needed. Work instructions were developed and the personnel were trained. The project objectives were accomplished since the cycle time for the report preparation was reduced and the report accuracy was enhanced. Key Terms - APRs, Batch Review Report, CFR Part 211, Cycle time.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesFall-2015;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industry--Quality controlen_US
dc.subject.lcshSix sigma (Quality control standard)
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleEnhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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