DQ IQ OQ PQ for cleanrooms and HVAC systems
DQ IQ OQ PQ are the four stages of qualification under EU GMP Annex 15. They prove that the system is correctly designed (DQ), correctly installed (IQ), operates within its defined parameters (OQ) and performs consistently in routine use (PQ).
What each stage covers
| Stage | Question it answers | Example checks | Deliverable |
|---|---|---|---|
| DQ (Design Qualification) | Does the design meet the URS and GMP? | Review of zoning, ISO Class/Grade, pressures, air change rates | DQ report |
| IQ (Installation Qualification) | Is it installed to the design? | Equipment check, as-built drawings, instrument calibration certificates | IQ report |
| OQ (Operational Qualification) | Does it operate within defined parameters? | Airflow, pressure, particles (at rest), temperature, humidity, HEPA leaks | OQ report |
| PQ (Performance Qualification) | Does it perform consistently in production? | Particles (operational) and stability of conditions over time | PQ report |
Photos from real sites
On-site checks and recording of results to the protocol
Reference standards
EU GMP Annex 15 (Qualification and Validation) · PIC/S PE 009-17 · WHO TRS 961 Annex 5 (HVAC) · ISO 14644-1 and 14644-3
Frequently asked questions
How do IQ and OQ differ?
IQ checks that the system is installed to the design. OQ tests that it reaches the defined values when it runs.
Is PQ needed every time?
PQ is done when the system is ready for routine use. After that it must be requalified periodically, or whenever a change affects its qualified state.
What is a URS?
The User Requirement Specification is the document in which the user defines the system requirements. It is the starting point for DQ and is traced through every stage.
Which stages does QV TEST cover?
QV TEST covers every stage, from DQ, IQ and OQ through to PQ, for cleanrooms and HVAC systems.
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Tell us the system to be qualified, the number of rooms and AHUs, and the stages you need
