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. 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.

The guidance does not address process analytical technology, as routine in-process use of these methods might include other considerations. The use of continuous on-line testing technologies will be addressed in other agency guidance, the FDA said.

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