Out-of-Specification Laboratory Investigations: New Look at an Old Issue

Abstract: Despite the guidance that is in place, many regulatory cite poor OOS investigations and these features high up on lists of inspectorate findings. Failure to conduct detailed OOS investigations or not producing OOS investigations of sufficient quality regularly features among the top five inspection findings from European Union regulatory agencies and also from the U.S. Food and Drug Administration. This paper takes a look at how OOS are conducted and presents different ways through which OOS investigations can be improved. While the OOS concept discussed is generally more applicable to analytical data than microbiological data, there are aspects in this paper that will be of interest to all laboratory disciplines working in a regulated GMP environment. The paper provides some best practice tips and short case study.

Audits • Best Practices • Compliance • Investigations • Laboratory Issues • Quality • Testing