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Requalification and periodic review

Qualified status is not permanent. Change control, periodic review and monitoring data together decide when a system must be requalified.

ValiTrac AI editorialUpdated 2026-09-132 min read
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Annex 15 requires equipment, facilities, utilities and systems to be evaluated at an appropriate frequency to confirm they remain in a state of control, and requalification to be considered where changes occur. The evaluation should use evidence rather than repeat the original studies by default.

Evidence for periodic review of a storage area

  • Continuous monitoring data at the mapped worst-case locations, compared with the mapping baseline.
  • Excursion and alarm history.
  • Calibration history of monitoring sensors.
  • Changes since the last review: racking, HVAC service, door usage, product range.
  • Any seasonal extremes not covered by the original mapping.

The review concludes either that the qualified state is maintained, or that targeted re-mapping is needed — and records why.

Frequently asked questions

Is annual re-mapping mandatory?
No regulation fixes an interval. A documented risk-based decision, supported by monitoring data, is what is expected.

References

  1. [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
  2. [2]ICH Q9(R1): Quality Risk Management

General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.

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