Oos results root cause not identdied

in oos results root cause not identified in (qc and mfg) batch was rejected or any alternate is there.

is the OOS for EM, Utilities, bioburden samples or finished product? If you can provide more information then it will be possible to provide some guidance

finished product

Root cause not identified means your investigation is not suficient…
OOS occured means there is a deviation during analysis or manufacturing…
For any OOS result, there will be root cause. U have to find out by thorough investigation in QC/PDN.


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