IQ / OQ / PQInstallation / Operational / Performance Qualification
IQ, OQ and PQ (installation, operational and performance qualification) are stages for showing that equipment or systems are installed correctly, operate as intended across their ranges, and perform consistently in routine use.
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EU GMP Annex 15 describes them; FDA's process validation guidance covers the same activities within Stage 2.
On this page · 5 sections
How does IQ / OQ / PQ apply to your shop floor?
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01What each stage shows
| Stage | Question it answers | Typical evidence (Annex 15) |
|---|---|---|
| DQ (design qualification) | Does the design meet the user requirements? | Traceability from URS to design |
| IQ (installation) | Is it installed as designed? | Components against drawings and specifications, calibration of instruments, materials of construction |
| OQ (operational) | Does it operate as intended over its expected range? | Tests of functions and of upper and lower operating limits ('worst case') |
| PQ (performance) | Does it perform consistently in routine use? | Runs with production materials, qualified substitutes or simulated product, over the expected range |
02Where the terms come from
EU GMP Annex 15 uses IQ, OQ and PQ explicitly and says PQ should normally follow successful IQ and OQ, though it may sometimes be performed together with OQ or process validation where justified. FDA's 2011 guidance places equipment and utility qualification within Stage 2 (process qualification) — verifying installation against design and operation across anticipated ranges — without requiring the IQ/OQ/PQ labels. Both are guidance; the underlying obligations come from GMP regulations.
03Worked example: a new blender
- IQ: confirm model, motor rating, product-contact materials and installed utilities against the specification; record instrument calibration.
- OQ: run empty and loaded at minimum and maximum speeds and timer settings; confirm alarms and interlocks.
- PQ: blend representative product at the routine batch size and show uniformity meets the acceptance criteria over several runs.
Each protocol has pre-approved acceptance criteria; deviations are investigated and the final report is approved by people with that authority before routine use.
04Common failure modes and checks
- Acceptance criteria written after testing.
- OQ that never challenges operating limits.
- Supplier FAT/SAT reused without checking it covers what the protocol needs (Annex 15 allows this only where justified).
- No requalification after changes, contrary to change control and periodic review expectations.
05Where V5 fits
For software, Enterprise may include IQ/OQ documentation and validation support for V5. V5 does not supply or perform your PQ: you plan it, run it with your processes and data, and approve the result. V5's calibration and asset records can also hold qualification status for equipment, but protocol approval and release decisions remain with your people.
Frequently asked questions
Q.Is IQ/OQ/PQ required by law?+
The terms come from guidance such as EU GMP Annex 15. Regulations require equipment and processes to be suitable and validated; IQ/OQ/PQ is the common way to show that.
Q.Must PQ follow OQ?+
Annex 15 says normally yes, but PQ may sometimes be combined with OQ or process validation where justified.
Q.Does V5 provide PQ?+
No. Enterprise may include IQ/OQ documentation and validation support; the customer plans and runs PQ.
Q.Does FDA use the term PQ?+
FDA's 2011 guidance uses process performance qualification (PPQ) for the process; equipment qualification sits within Stage 2.
Primary sources
Further reading
Explore this topic
IQ / OQ / PQ sits inside 4 overlapping topic clusters in our glossary. Every neighbour is one click away.
Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
ICH Q8/Q11/Q12 toolkit — Quality by Design, design space, control strategy, CPV and lifecycle management.
URS-through-PQ lifecycle, GAMP 5 categorisation and CSA's modern alternative.
Want to see how IQ / OQ / PQ could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.