ABSTRACT
ICH Q10, the international guidance on the Pharmaceutical Quality System, published in 2008 was the first formal acknowledgment of the need to integrate and use knowledge effectively throughout an organization's quality management system. This chapter outlines how knowledge management has become invaluable at Eli Lilly and Company, and shares several examples of how KM is now enabled through the quality management system. It provides an overview of the ways in which knowledge management can be successfully integrated into the quality management systems of an organization, using Eli Lilly and Company (Lilly) as an example. ICH Q10 reminds us that there are three key deliverables such as product realization, maintaining a state of control and continual improvement for pharmaceutical manufacturing. Knowledge management is most effective when built into the day-to-day operations of an organization, rather than operated as a separate system. The chapter provides examples to the approach at Lilly has utilized to integrated knowledge management within the quality management system.
