Laboratory Failure Investigations

• The FDA requires that an investigation be conducted whenever an Out-of- Specification (OOS) result is observed. This SOP defines the Requirements for dealing with failed test results.
• Upon completion of the analysis the analyst checks the results for Specifications.
• The tests should be carried out by two different analysts in duplicate. The analysts should be different to the ones who did the original analysis.
• Investigation reports should include: steps taken, raw data, supporting documents, findings and explanations, conclusions and recommendations to avoid occurrence of similar deviations in the laboratory.

It Provides information on:

• Responsibilities
• Frequency of use
• Procedure.