Help on: Investigating Out of Specification (OOS) Results

MTS HELPDESK

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Question:
“If any sample fails in testing, i.e. OOS or OOT, then what sort of thing does an analyst have to do, and what is basic difference between OOS &OOT?”

Answer:
“The difference between out of specification (OOS) and out of trend (OOT) results was discussed in a previous MTS helpdesk enquiry. I recommend that you refer to the FDA Guideline ‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production’ for a detailed description of the procedure for investigation of an OOS or OOT result.”