Buyer guide
Pass box qualification: DQ, IQ, OQ and PQ
Pass box qualification follows the EU GMP Annex 15 chain: URS, DQ, IQ, OQ and PQ, each proving one more thing about the box. The annex lists no pass box tests, so the owner's protocol sets them.
By ZY Cleanroom · Updated · Sources at the end of the page
The stages
This guide uses the 2015 text of Annex 15. EMA opened a revision with a concept paper in 2026 and proposes final publication in April 2028, so check the version in force.
| Stage | What Annex 15 asks | Example evidence for a pass box |
|---|---|---|
| URS (para 3.2) | A written specification, kept as the reference for the whole life cycle | Size, grades of both rooms, interlock type, material list |
| DQ (para 3.3) | Design shown to comply with GMP and the URS | Drawings, filter grade, interlock logic |
| FAT and SAT (paras 3.4 to 3.7) | Tests at the vendor, then on site where useful | Factory test record |
| IQ (paras 3.8 and 3.9) | Installed as drawn, supplier instructions collected, instruments calibrated, materials verified | Wall seal check, serial numbers, gauge certificates |
| OQ (paras 3.10 and 3.11) | Operates as designed, with upper and lower limits tested | Interlock, airflow, filter leak test, pressure |
| PQ (paras 3.13 and 3.14) | Performs effectively and reproducibly, with production or simulated material | Particle counts, recovery, loaded transfer |
Combining and reusing tests
Annex 15 (para 3.6) lets some FAT tests stand in for IQ and OQ where justified, if transport and installation do not affect them. Depending on the complexity of the equipment, OQ may be run with IQ as one IOQ (para 3.10). PQ may sometimes run with OQ (para 3.13). A successful OQ lets the owner finalise operating and cleaning procedures, operator training and maintenance needs (para 3.12).
What Annex 1 says about the box itself
Annex 1 (para 4.12) asks that pass-through hatches protect the higher-grade side, for example by flushing with an active filtered air supply. Only items on an approved list, assessed during validation of the transfer process, go through into grade A or B. So PQ should cover the transfer process, not only the empty box.
Para 4.13 says the entry and exit doors of hatches and airlocks should not open together. It asks for interlocks on airlocks leading to grades A and B, and at least a warning for grades C and D. Decide in your protocol how that wording applies to the box.
Example: OQ and PQ test list
Example only. Neither annex lists pass box tests. Annex 1 (para 4.25) lists tests for cleanrooms and clean air equipment. An active box with its own fan and filter can borrow from it.
OQ: interlock works both ways, indicators and alarms work, airflow at the filter, filter leak test, and pressure difference to each room. PQ: particle count in the chamber at rest against the grade the owner sets, recovery after a disturbance, and transfer of approved items. Include the disinfection step from the contamination control strategy.
Requalification
Annex 15 (para 4.1) asks for evaluation at a suitable frequency to confirm the equipment stays in a state of control. If the owner treats the box as clean air equipment, Annex 1 (para 4.32) applies. It caps requalification at 6 months for grades A and B and 12 months for grades C and D. A change of final filters is a change to consider.
Documents to request
Ask for the documents that let you finish IQ. Annex 15 names drawings and specifications, supplier operating and maintenance instructions, instrument calibration and materials of construction. Add the filter test certificate, the interlock description and the factory test record.
Who approves the room
Your regulator or customer auditor judges the facility, not the contractor. The owner approves the protocol and the results. To have a room list reviewed, send it to ZY Cleanroom, a cleanroom design-and-build contractor.
Questions
Common questions
What is the difference between IQ and OQ for a pass box?
IQ checks the box was installed as drawn, with instruments calibrated and materials verified. OQ checks it works as designed, including its upper and lower limits (Annex 15, paras 3.9 and 3.11).
Can the factory test replace tests on site?
Only where appropriate and justified, and when transport and installation do not affect the function (Annex 15, para 3.6).
Does a pass box without a fan need qualification?
Annex 1 asks that hatches protect the higher grade and that transfers are validated. How much testing a box without a fan needs is the owner's decision, set by risk.
Who writes the qualification protocol?
The owner. FDA (2004) keeps drug manufacturers responsible for test methods and acceptance criteria when contractors certify air systems. Annex 15 (para 2.6) says site staff should confirm a third party's protocol is suitable before approval, so a supplier can offer a draft.
How do you validate a UV pass box?
Annex 1 says ultraviolet irradiation is not an acceptable method of sterilisation (para 8.71), so do not rely on the lamp as the transfer control. Qualify the box as you would any other, then add checks on lamp output, lamp hours and the timer interlock. The owner decides by risk whether the lamp is kept at all.
How do you validate a VHP pass box?
Annex 1 (para 4.36) says the effectiveness of a vapour agent and its dispersion system should be understood and validated. In practice, this means developing the cycle, proving distribution with biological indicators at the worst positions, and confirming aeration to a safe residual level. The owner's quality team approves the protocol and the result.
Related guides
- USP <797> compounding cleanroom for hospital pharmacy
- Cell and gene therapy cleanroom design: grades, segregation and flows
- Contamination control strategy: what the building and air must provide
- Upgrading an existing cleanroom for EU GMP Annex 1: gap list
- Turnkey cleanroom contractor
- Room list builder
Sources
- EudraLex Volume 4, Annex 15: Qualification and Validation (European Commission, 30 March 2015; in operation from 1 October 2015; checked 31 October 2026)
- European Medicines Agency, Concept paper on the revision of Annex 15, EMA/INS/GMP/163466/2026 (19 January 2026, revised timetable; checked 31 October 2026)
- EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products (published 25 August 2022, applied from 25 August 2023; checked 31 October 2026)
- FDA, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice (September 2004, nonbinding; checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
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