Requalification of an Automatic Inspection System (AVI)

If the visual inspection is carried out with an automatic inspection system (AVI), function tests should be carried out regularly. Does the AVI system still need to be requalified regularly?

According to EU GMP, a distinction must be made between the following activities for a fully automated system:

  • Qualification: in the case of new equipment
  • Requalification: evaluation of the equipment within defined time intervals
  • Functional tests: test before starting operation (and preferably also after completion of operation)
  • Periodic evaluation: in accordance with EU GMP Annex 11

Functional tests focus exclusively on sensor functionality and are typically performed before and after batch testing. Due to the limited scope, a functional test cannot replace the requalification of equipment. Requalification should be performed in accordance with Annex 15 of the EU GMP to ensure that all equipment remains in a controlled condition. Requalification and intervals should be planned and justified according to the GMP rules.

The periodic evaluation according to EU GMP Annex 11 can be part of the requalification.

The requalification of an automated inspection system should ideally take place every year, but at least every two years. This must include an evaluation of the changes and deviations that have occurred during the period of operation. A statistical trend analysis of the performance data obtained during routine batch testing should also be included. The results of the routine functional tests listed in the question are also taken into account here. A statement based purely on the evaluation of the functional tests is not sufficient - which was the initial question.

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