Dear All,
In couple of weeks, I plan to make a presentation on OOS.
Before this, I would like to calrify my queries regarding OOS [Out of Specification results]
- How to disregard / invalidate the intial values?.
- How FDA will interpret, if assignable cause was identified during prelimnary investigation & no root cause was identified up to final invetigation for lab error?.
3.How to investigate / proceed, if sample preparation is discarded or solution stability is over?
4.What kind of approach can be followed for the sample, to be prepared freshly? [In case of Related susbtances]
5.How to investigate OOS in micro test?
6.During OOS investigation, if second or third analyst result are satisfactory or Vice versa, Is there any additional investigation [like preliminary investigation] is required to conclude?.
7.What would be FDA’s interpretation, If re sampling is done? [Situation for RM/FP]
8.What would be FDA’s expectation, in case of dissolution failure?
9.How to verify impact of remaining batches analysed on same sequence?. [Assume , my HPLC sequence for
Assay has different batches & only one batch falls in OOS] - Whether , it is really needed, to add a sample [which has been passed during second set?