Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022 

USFDA has published a revised version of Guidance for Out of specification investigation in May 2022.
The USFDA Guidance provides details regarding steps for investigation the OOS including the Phase-I Laboratory Investigation, Phase-II Full Scale Investigation, responsibility of analyst, responsibility of supervisor.
The Guidance also provides details regarding retesting, resampling and averaging of test results with their appropriate and inappropriate use.