Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

On 16 May 2022 the FDA published Final Level 2 revised guidance.

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (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. The term also applies to all in-process laboratory tests that are outside of established specifications.

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