Oos results root cause not identdied

Quality Control
1

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

2

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

3

finished product

4

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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