Monday, 11 March 2019

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

Since 2006, regulatory agencies have produced guidance on conducting OOS investigations. In addition, many laboratories have established internal procedures so that OOS investigations are consistently undertaken. Indeed, the investigation of an OOS should be covered by a Standard Operation Procedure (SOP) and formally documented. The SOP should contain decision tress to ensure that, where possible, the conclusions reached are consistent.

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.

Tim Sandle has taken a fresh look at laboratory OOS investigations in a new article:

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.

The reference is:

Sandle, T. (2018) Out-of-Specification Laboratory Investigations: New Look at an Old Issue, Journal of GXP Compliance, 22 (6): 1-10

See IVT -

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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