Federal Register
Notice: FDA is making available a guidance for industry entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. This guidance provides information on how to evaluate laboratory test results that fall outside of specification limits. This includes OOS results in the laboratory phase, responsibilities of the analyst and supervisor, and when indicated, the expansion of an investigation outside of the laboratory to include production processes, and raw materials as appropriate. This guidance applies to traditional methods of drug product testing and release, and not to process analytical technology. To download the guidance, click here. To view this notice, click here.