GMP Tips - New OOS Guidance - Oct 16, 2006

In an effort to help pharmaceutical manufacturers evaluate test results, the FDA issued 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 guidance document covers 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;
• The final evaluation of all test results.

Download a copy of this new guidance
"Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"
Go to www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources

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