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.
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
Good article and good information for an user
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