OOS Investigation

It's quite common to observe in QC laboratories, a test result, which is obtained out of a specification limit. This is technically called as "out of specification" or called shortly as OOS. 

Once the quality unit observed an OOS data, it becomes important to investigate the origin of this OOS data. 

As per Quality unit procedure as well as Regulatory requirement, it is necessary to initiate the laboratory investigation for possible root cause identification due to error in analysis viz., human error, instrument performance, calculation error, selection of test method etc.

Sometimes the root cause of OOS results could be due to manufacturing issues like operator error, equipment failure, quality of materials used, deviation in operation etc.

Based on investigation report, root cause of the OOS result will be identified and suitable CAPA (corrective and preventive measures) will be implemented to avoid recurring of same OOS failures  in future.

Both CDER and EU GMP guidelines are available on handling OOS Investigation in Pharma manufacturing.

A good presentation on OOS Investigation is attached for more details.



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