What are the corrective actions to be taken incase of there is any oos or breakdown in stability studies due to failure of results or due to other equipment utility problems.
please guide me if there is any solution that accepted to regulatory.
All the OOS results have to be investigated following your internal SOPs to identify the root cause. If the OOS is due to an assignable cause like Chemist error or system (HPLC or GC) failure etc, then you have the option to invalidate the original results and retest the sampels following your SOPs. If there is no assignable cause, you need a good and scientifically acceptable retest program for the retest and also your SOP should clearly state the procedures for reporting the final results.
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