Decommissioning of Retain Samples and GMP Documentation at a Manufacturing Site

Abstract

During the past couple of years Elkay Corporation has been pushing to consolidate the product supply of its Hallo™ brands on a global scale. Elkay’s Skin Care business which operates one of its plants in Puerto Rico, Elkay Corp., has decided to permanently seize operations of the Puerto Rico site effective June 2016. As a result of this business decision, the Elkay Corp. site has set a Decommissioning Plan which includes documentation and production sample transition to the production receiving site of San Diego, CA. This project will focus on the decommissioning of Retain Samples and GMP documentation, complying with Food and Drug Administration (FDA) and corporate guidelines. A focus on the DMADV (Define, Measure, Analyze, Design and Verify) tool for organizing and executing the project has been adopted. At the later stages of the project emphasis on results and next steps will provide a clear outlook on the remaining milestones not covered in the scope of this report. Key Terms - DMADV, FDA, GMP Documentation, Retain Samples.