The process which will be described here is based on the process discussed in the MHRA’s guidance on Out of Specifications Investigation.
When an out of specification, atypical or suspect result is obtained, it is particularly important that all solutions and reagents associated with the test are retained, as this will greatly assist the investigation.
The MHRA advocate laboratory investigations should proceed in four phases as follows:
Phase I(a)
Phase I (a) consists of a preliminary review, by the analyst, to determine whether there has been a clear and obvious error or event that caused the OOS, atypical or suspect result.
Phase I(b)
Phase I (b) occurs after phase 1(a) has failed to identify a clear and obvious cause. This is a more detailed investigation by the analyst and supervisor to identify a laboratory assignable cause.
Phase II
Phase II occurs after the phase I investigation has failed to identify a laboratory assignable cause for the OOS, atypical or suspect result and are driven by written and approved instructions in order to test particular hypothesis.
Phase III
In Phase III all the information obtained during Phases I and II of the laboratory investigation, and any manufacturing investigation, is reviewed and assessed, and a decision is made on the disposition of the batch
Learn More About Laboratory Investigations
If you would like to learn more about laboratory investigations click here for an overview of this course.