Frequently Asked Questions and Answers on Out of specification (OOS)
Q. Do we need to initiate an OOS investigation if OOS results are found during API Method Transfer?
Ans: Yes, if it happens at the originating lab. If it happens at the receiving lab, handle it through a lab incident or deviation to identify the root cause as per in-house SOP; no OOS is needed.
Q. Do we need to raise an OOS investigation if OOS results are observed during vendor API evaluation?
Ans: No, It can be handle through lab incident or deviation to identify the root cause as per inhouse SOP.
Q. Do we need to raise an OOS, if OOS results obtained while bracketing standard failed?
Ans: Ideally, yes, OOS results should be investigated through an OOS investigation. However, another view is that if system suitability fails, the results are invalid, so there’s no need to raise an OOS. Instead, it should be investigated as a lab incident.
Q. Do we need to raise an OOS, if API results OOS during working standard qualification?
Ans: Yes, investigate through OOS if the API is used in manufacturing. No, if the API is only for working standard qualification, handle through lab incident.
Q.: If OOS results obtained during investigation of OOT or Lab incident, Do we need to raise an OOS?
Ans: If hypothesis performed as per STP, then OOS should be taken. (Ideally, hypothesis testing should not be exactly as per STP. If you follow the same procedure as hypothesis, it indicates that you are checking the sample meets the spec. or not). If hypothesis is not performed as per STP, no OOS need to be taken.
Read also:
- Pharmaceutical Quality Control Interview Questions and Answers
- Pharmaceutical Quality Compliance Interview Questions and Answers
- OOS Investigation as per FDA Guidance
Resource Person: Vikas Bedi
