Guidance for Industry on Investigating Out-of-Specification Test Results for Pharmaceutical Production; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Investigating Out- of-Specification (OOS) Test Results for Pharmaceutical Production." This guidance provides information for the pharmaceutical industry on how to evaluate laboratory test results that fall outside of specification limits. The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements.