Out of Specification & Atypical Results


Lesson Code: PGL-1200. This e-Lesson is aimed at personnel who require an overview of 'Out Of Specification' (OOS) and Atypical Results in the analytical laboratory, including how they are investigated, and how they can be prevented.


  • Category: Analytical Laboratory - GMP

Description

After taking this e-Lesson, you will be able to:

  • Define the terms 'Out Of Specification' (OOS) and 'Atypical Results'
  • Explain why OOS and Atypical Results are important
  • Describe how these results can occur
  • Describe ways in which OOS and Atypical Results can be prevented
  • Describe the sequence of steps taken to investigate OOS and Atypical Results

KEYWORDS: Assignable Cause, Atypical Result, Barr Decision, EMA, FDA, Laboratory Error, Non-Assignable Cause, OOS Investigation, Out of Specification (OOS) Result, Resampling