By Mark Durivage, Quality Systems Compliance LLC

Published in: Pharmaceutical online

Published on: June 24, 2022

Introduction: On May 16, 2022, the FDA’s Center for Drug Evaluation and Research (CDER) released Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision Guidance for Industry. The purpose of this guidance is to provide the FDA’s current thinking on how to evaluate out-of-specification (OOS) test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results.

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