FDA Announces Guidance on Out-of-Specification Test Results

In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.The designation also covers in-process laboratory tests.

The document, 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production,' is being published in the Oct. 12 Federal Register."