Company: Gilead Sciences
Liaison(s): Gwen Steavens
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Its focus is to transform and simplify care for people with life-threatening illnesses around the world. Gilead’s portfolio of products and investigational drugs includes treatments for HIV/AIDS, liver diseases, serious respiratory and cardiovascular conditions, cancer and inflammation. Gilead has several manufacturing facilities. Gilead’s San Dimas facility is a sterile-fill facility which is responsible for the manufacturing of an antifungal agent, AmBisome®; the packaging and labeling of Gilead’s antiviral products; and, the distribution of products to the America’s and the Pacific Rim. Pharmaceutical manufacturing processes are strictly regulated and accurate documentation is of paramount importance. Every step in the manufacturing process must follow established protocols. Documentation, during the manufacturing process, provides a summary of real-time events and confirms all validated processes were carried out according to specifications. Currently, Gilead’s San Dimas facility has highly manual methods of documenting manufacturing processes. Key documented processes include data entry by shift leaders to account for labor allocation and the compilation of FDA-mandated batch records. Each of these processes is manually carried out by employees. While the San Dimas’ manual documentation methods are sufficient to ensure that their products meet FDA standards, their manual documentation methods do not provide management the level of visibility needed to track and assess performance and overall equipment efficiency (OEE). The Gilead Operational Excellence TMP team was tasked with understanding data gathering systems currently in place in the manufacturing department at the San Dimas facility. Further, the team was asked to recommend improvements or to recommend new systems for Operational Equipment Effectiveness (OEE) studies which would include the analysis of labor and process tracking. After analyzing the current data gathering systems, they identified equipment, process and people tracking needs and prioritized them in the form of a user requirement specification list (URS). A comprehensive search for commercial OEE solutions was performed which identified the top options. Eventually, the team identified solutions for high, mid, and low tier automated options as well as an improved manual option. These recommendations were followed by a SWOT analyses of the solutions to evaluate how well they meet San Dimas’s needs. Finally, the team provided an implementation plan for the improvement/new system in the facility.