IQ, OQ and PQ explained
Installation, operational and performance qualification are three questions asked in order: is it installed as specified, does it operate across its ranges, does it perform in routine use?
Qualification builds evidence in layers. Each stage has a protocol with pre-defined acceptance criteria, an execution record, and a report approved before the next stage begins — or with a documented justification where stages overlap.
For a temperature-controlled chamber or room
- IQ: equipment identity, utilities, sensor positions, calibration certificates for controllers and monitoring sensors, drawings, manuals, software version.
- OQ: control at set points across the range, alarm function, door-opening recovery, power-failure behaviour, empty-chamber temperature distribution.
- PQ: loaded mapping under routine operating conditions, over a duration that captures normal use, against the product-derived acceptance criteria.
The mapping study is therefore not a separate activity bolted onto qualification; it is the substance of OQ and PQ for temperature-controlled spaces.
Frequently asked questions
- What is DQ?
- Design qualification: documented verification that the proposed design is suitable for the intended purpose, performed before purchase or build.
- Must PQ use real product?
- Annex 15 allows simulated product where justified; the justification and the simulation's limitations should be recorded.
References
- [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
- [2]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
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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