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dc.contributor.advisorSchultz, David E.
dc.contributor.advisorFredrich, Augustine J.
dc.contributor.advisorSprouls, Eric P.
dc.contributor.advisorShankland, William J.
dc.contributor.authorMayes, Douglas
dc.date.accessioned2019-12-09T18:13:47Z
dc.date.available2019-12-09T18:13:47Z
dc.date.issued2002
dc.identifier.urihttp://hdl.handle.net/20.500.12419/414
dc.descriptionThesis available in Rice Library University Archives and Special Collection.
dc.description.abstractThe Drug Master File (DMF) is a document, when on file with the United States Food and Drug Administration (FDA), is referred to by FDA auditors in support of Rexam customer applications for new drugs. Rexam's DMF had originally been submitted in a format that the FDA no longer accepts. The file had been rewritten in 1999 to comply with the new requirements; however, it was not complete and had been prepared in a format that would make it very difficult for FDA reviewers to follow and understand. Rexam had retained a third-party to conduct an audit of its DMF and provide recommendations on revisions necessary to meet FDA requirements. The purpose of this project is to provide for the revisions of Rexam's DMF in order to meet FDA and its customers requirements for new drug certification and approval. This project thesis outlines the major efforts to perform the following objectives: � Condense multiple DMF's into a single submission; � Write procedures to maintain the DMF as a Living Document; � Develop a system to manage customer Letters of Authorization; � Change all of the drawings within the DMF to product data sheets; � Develop a system to manage supplier regulatory information; and � Train appropriate Rexam associates. The successful development and implementation of this DMF will enhance Rexam's competitive position with its current and future customers in the marketplace.
dc.titleDevelopment of a drug master file, corresponding policies, and procedures to meet food and drug guidelines and requirements
html.description.abstractThe Drug Master File (DMF) is a document, when on file with the United States Food and Drug Administration (FDA), is referred to by FDA auditors in support of Rexam customer applications for new drugs. Rexam's DMF had originally been submitted in a format that the FDA no longer accepts. The file had been rewritten in 1999 to comply with the new requirements; however, it was not complete and had been prepared in a format that would make it very difficult for FDA reviewers to follow and understand. Rexam had retained a third-party to conduct an audit of its DMF and provide recommendations on revisions necessary to meet FDA requirements. The purpose of this project is to provide for the revisions of Rexam's DMF in order to meet FDA and its customers requirements for new drug certification and approval. This project thesis outlines the major efforts to perform the following objectives: � Condense multiple DMF's into a single submission; � Write procedures to maintain the DMF as a Living Document; � Develop a system to manage customer Letters of Authorization; � Change all of the drawings within the DMF to product data sheets; � Develop a system to manage supplier regulatory information; and � Train appropriate Rexam associates. The successful development and implementation of this DMF will enhance Rexam's competitive position with its current and future customers in the marketplace.
dc.contributor.degreeMaster of Science in Industrial Management
dc.typeThesis (M.S.I.M.)--University of Southern Indiana, 2002


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