Hello everybody. Are there guidelines for the management of the OOS during the Cleaning Validation phases?
I don’t know how to handle them. Whether as a laboratory OOS or process deviations.
Thanks!
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The USFDA guidance for industry on Investigating Out-of-Specification (OOS) Test Results
for Pharmaceutical Production provides the Agency’s current thinking on how to evaluate out-of specification (OOS) test results. The term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.
Therefore, OOS lab results obtained during Cleaning validation are out of the scope of this guidance.
Such OOS results can be investigated separately using the principles of this guideline.
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