Key issues for establishing a roboticslaboratory in the pharmaceutical industry

摘要

The Analytical Research and Development Department of Bristol-Myers Squibb has a laboratory dedicated to robotic analysis of solid dose forms. It consists of eight individuals responsible for nine robotic systems. 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 year for approximately six long-term stability programs. The key issues for success were personnel selection, methods development (methods transfer), routine assay support, documentation, validation, training and support services. This paper discusses the establishment of the laboratory and the future issues important to continued success.