Monday 12 July 2010

Help on: Investigating Out of Specification (OOS) Results


Do you have any problems relating to analytical chemistry for pharmaceuticals or training? Send your questions to the MTS helpdesk using our contact form.

“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?”

“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.”

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