FDA RELEASES 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," was published in the Oct. 12 Federal Register. It discusses such topics as:

• How to investigate OOS test results;
• The laboratory phase of the investigations;
• Responsibilities of laboratory personnel, such as the analyst and supervisor;
• When to expand the investigation outside the laboratory to include the production process and raw materials;
• Additional testing that may be necessary; and
• The final evaluation of all test results.

In response to comments on a 1998 draft version of the guidance, the FDA has revised the scope and background sections of the document to clarify its applicability; reorganized the sections on investigating OOS results, averaging and concluding the investigation; and clarified or added specifics on certain issues.

The guidance can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/98d-0777-gdl0002.pdf.