If failure is observed for any parameter during stability study conducted beyond the shelf life period, does an OOS needs to be logged?
After “OOS” observed it should be log, and if batches is commercialize the what test is out of specification, and what will be harm of severity to human, decide to product recall
You should check that the OOS observed is at the time point which is within the approved shelf life in any market…?
It is for same storage conditiins as approved?
It is for same formulation and test parameters as approved?
There should not be any outlier due to one time manual error.
If yes, you should file variation to reduce the shelf life otherwise do routine investigation and close the OOS.
OOS, OOT, deviation investigation is a formal investigation system in cGMP system. So, i we encounter any OOS or OOT, whether it is a for information study or actual study, we should investigate it through formal investigation system to determine whether it is a Laboratory error or material concern.
If it is proved as laboratory error, a CAPA shall be provided to prevent the recurrence.
If it is a material concern, we may continue the study for information purpose to get the knowledge on the product or may be discontinue the study.