In pharmaceutical industries specially in Quality control laboratory, it is very difficult to decide that the event should be handle through Deviation or Incident, it is always debatable.
So we should have a clear cut SOPs where it should be clarify that event should be handle through which QMS documents.
From my view, any deviation of SOP Should be handle through deviation.
Apart from SOP deviation all laboratory events should be handle through Incident.
And in any laboratory events, if result is not with in specification limit, then it should be handle through OOS only.
For example,
Case-1:
Analyst had selected wrong wave length.i.e.354 nm instead of 254 nm) , but all results are well with in limit.
Case-2:
Analyst had forgot to inject the bracketing system suitability injection (for resolution), while injected diluted standard for bracketing RSD% (It is part of SOP for bracketing injection). All results are well with in limit.
Case-3:
Bracketing System suitability parameters are failed due poor column efficiency, and due to poor peak shape (its look like principal peak split) sample is failed in unknown impurity.
My take
For case-1 ,
Analyst was not followed the STP, hence it should be handle through Laboratory Incident.
For case-2,
Analyst had not followed the SOP , So it should be handled through Deviation.
For case-3
Here result is Out of Specification, hence this case should be handled through OOS only.
In any case ,if result is OOS then it should be handle through OOS Only, either STP deviation or SOP deviation. Even though, result may be 0% due peak not eluted, It should be handle through OOS .
About the Author
