FDA Guidance Document: Investigating Out-of-Specification (OOS) Test Results For Pharmaceutical Production

This guidance for industry provides the Agency's current thinking on how to evaluate out-ofspecification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. Submitted by the Food and Drug Administration