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]

  1. How to disregard / invalidate the intial values?.
  2. 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]
  3. Whether , it is really needed, to add a sample [which has been passed during second set?