What action to be taken if an OOT result is confirmed

GMP
1

What action to be taken if an OOT result is confirmed

2

In my opinion that may be done root cause analysis for OOT. It prevents possible OOS.

3

If OOT is confirmed, it should be investigated by Cross functional team to identify the CAPA. Stability data shall be verified for whether the batch can be released or rejected. If, stability data is showing that the impurities are not increasing , batch can be released otherwise it should be rejected and reprocessed.

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4

It is clearly addressed on MHRA OOS,OOTguidelineā€¦

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If OOT is observed it shall be investigated for all 4 Ms - find out CAPA, was there any previous history for the same , check stability data, is it intermediate if so what is the effect on next step or final product , based on these details of investigation decision shall be taken.

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4Ms means

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4M means MAN,MATHOD, MACHIN &MATERIAL

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Thanks a lot