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USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production". This guidance for the industry provides the Agency’s current thinking on how to evaluate Out-Of-Specification (OOS) test results.

This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods.

These laboratory tests are performed on active pharmaceutical ingredients, excipients, and other components, in-process materials, and finished drug products to the extent that current good manufacturing practice (CGMP) regulations.

The principles in this guidance also apply to in-house testing of drug product components that are purchased by a firm. This guidance can also be used by contract firms performing production and/or laboratory testing responsibilities.

Specifically, the guidance discusses how to investigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results.

Click on the LINK to know more about this guidance on investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.


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