KEY ISSUES FOR ESTABLISHING A ROBOTICS LABORATORY IN THE PHARMACEUTICAL-INDUSTRY

The Analytical Research and Development Department of Bristol-Myers Sq uibb has a laboratory dedicated to robotic analysis of Solid dose form s. It consists of eight individuals responsible for nine robotic syste ms. The laboratory is dedicated to the support of Phase III stability studies that require dissolution, potency, content uniformity and Karl . Fischer moisture assays. The group performs about 15000 assays a yea r for approximately six long-term stability programs. The key issues f or success were personnel selection, methods development (methods tran sfer), routine assay support, documentation, validation, training and support services. This paper discusses the establishment of the labora tory and the future issues important to continued success.