USA – FDA updates guidance on evaluating out-of-specification results for drugs

The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including the responsibilities of the analyst and supervisor in reporting these results.

FDA defines OOS results as “all test results that fall outside the specifications or acceptance criteria established in dug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.”

The update contains minor editorial changes from the 2006 version, clarifies concepts on outlier results, and provides additional information on averaging results from the same final sample preparation. It also replaces the term “quality control unit” to the currently favored terminology “quality unit.”…