TABLE II

Examples of Detection Controls That Serve Different Functions

Examples of Detection ControlsPotential Usefulness
An in-process control test for impurities and related substances Unacceptable levels of impurities and related substances can be detected during the process step in which they are generated and action can be taken to reduce them at an early stage.
Visual inspection of filled vialsGlass, foreign matter, and other contaminating materials in filled vials can be detected before the release of the batch.
Second person checks on a batch recordA check by a second operator of the correct execution of a step in a batch record can detect errors and non-compliances in a process before their effects are realized.
Increased inspection activity during packaging operationsAn increased level of product inspection during packaging processes can increase the detectability of defects.
Independent high temperature alarm switchUseful where temperature has been defined as a critical process parameter in that process step.