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 debatble.
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 results are not with in limit, then it should be handle through OOS only.
For example,
Case-1:
Analyst had selected wrong wave length.i.e.254 nm instead of 354 nm) , but all results are well with in limit.
Case-2:
Analyst had frogot 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 Incident.
For case-2,
Aanalyst 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 devation or SOP deviation. Even though, result may be 0% due peak not eluted, It should be handle through OOS only.
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 results are not with in limit, then it should be handle through OOS only.
For example,
Case-1:
Analyst had selected wrong wave length.i.e.254 nm instead of 354 nm) , but all results are well with in limit.
Case-2:
Analyst had frogot 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 Incident.
For case-2,
Aanalyst 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 devation or SOP deviation. Even though, result may be 0% due peak not eluted, It should be handle through OOS only.
Sir , I think first two should be handle through deviation and last one incident...If there is any departure from written procedure, should be deviation and if there is any predefined acceptance of suitability not meet,should be incident...I have no supporting documents regarding above, but some consultant recommending to follow like dis...
ReplyDeleteNow most of FDA auditor/consultant suggest to merge Incident and deviation and handle through deviation only.
DeleteIf we will investigate both case through deviation, then it is not an issue. But there should be clarity in our SOP, That which case handle through which QMS documents.
For case 3 many organizations got 483 to handle such cases through incident and now they are struggling to identify that how many such cases was investigated through incident.
FDA auditor recommended to handle all case through OOS where result is not meeting with specification for any XYZ reasons.
I agree that case 1 must be handled through an incident. But by no means a difference of 100 nm would have results within specification. Rather I would say that sample won't be injected at all as standard peak won't be there. For a single drug dosage form, detection wavelength is the absorption maxima of the drug. So with a difference of 100 nm, even standard peak won't be there. So it's a before test laboratory incident.
DeleteYes, if there is no standard and test peak ,then result will not generated and it's case of incident only.
DeleteSir many company does not have deviation they handle all the laboratory error (accept oos) through planned and unplanned incident. Is it OK
ReplyDeleteI don't think so, any company has no deviation SOP, Incident terminology has been used in laboratory only. For manufacturing/Engineering and other department , any deviation from procedure, planned or unplanned should be handle through deviation, that is not an incident.
DeleteFor laboratory events should be handle through deviation or incident is always debatable. That's why I am saying that our SOP should be clear on that.
My opinion
Any laboratory events occurred due to instrument error/column error/ other error and there is no deviation of any SOP and result is not an OOS should be handle through incident.