Key issues for establishing a roboticslaboratory in the pharmaceutical industry

[摘要] The Analytical Research and Development Department ofBristol-Myers Squibb has a laboratory dedicated to robotic analysisof solid dose forms. It consists of eight individuals responsible fornine robotic systems. The laboratory is dedicated to the support ofPhase III stability studies that require dissolution, potency, content.uniformity and Karl Fischer moisture assays. The group performsabout 15000 assays a year for approximately six long-term stabilityprograms. The key issues for success were personnel selection,methods development (methods transfer), routine assay support,documentation, validation, training and support services. Thispaper discusses the establishment of the laboratory and the futureissues important to continued success.

[学科分类] 分析化学