1What IQ, OQ and PQ are.
Qualification provides documentary evidence that facilities, supporting utilities, equipment and systems “are suitable for their intended use”.¹ EU GMP Annex 15, in operation since 1 October 2015, defines the three stages in its glossary:²³
| Stage | Annex 15 definition |
|---|---|
| Installation qualification (IQ) | “The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.”² |
| Operational qualification (OQ) | “The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.”² |
| Performance qualification (PQ) | “The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.”² |
Annex 15 describes itself as guidance for interpreting the GMP principles laid down in Directive 2003/94/EC for human medicines,² which Commission Directive (EU) 2017/1572 has since repealed.³ The same annex forms part of the PIC/S GMP Guide, and PIC/S PI 006-4, which entered into force on 1 October 2026 and updates the 2007 PI 006-3, is guidance and a training resource for inspectors and industry.¹ WHO sets out the same stages in Appendix 6 of TRS 1019, Annex 3 (2019).⁴
A targeted revision of Annex 15 has been proposed. EMA’s concept paper of 19 January 2026, agreed by PIC/S and open for comment from 9 February to 9 April 2026, would extend the annex, including its URS, FAT, SAT and DQ to PQ expectations, to active substance manufacturers, who now use it only as optional supplementary guidance.⁵
2Where the stages sit in the life cycle.
Annex 15 says qualification should consider every stage from the user requirements specification (URS) “through to the end of use of the equipment, facility, utility or system”.²
| Stage | What it shows | Examples of what it covers |
|---|---|---|
| URS | What the equipment must do | Essential quality elements built in and GMP risks mitigated; a point of reference throughout the life cycle.² PIC/S expects input from production, engineering, quality and others, and a controlled document.¹ |
| Design qualification (DQ) | The design meets the URS and GMP | A documented check of the design against the requirements; PIC/S calls it “a documentation verification process”.²¹ |
| Factory and site acceptance testing (FAT, SAT) | The equipment works at the vendor and on arrival | Equipment, especially with novel or complex technology, may be evaluated at the vendor before delivery, and FAT may be supplemented by SAT on receipt.² |
| IQ | It is installed correctly | Components, instrumentation, pipework and services against drawings and specifications; supplier operating, working and maintenance instructions; calibration of instrumentation; materials of construction.² WHO asks for calibration traceable to national or international standards.⁴ |
| OQ | It operates as designed | Tests developed from knowledge of the process and equipment, and tests of upper and lower operating limits or “worst case” conditions.² Test equipment is calibrated and test methods validated before use.¹ |
| PQ | It performs in normal use | Tests with production materials, qualified substitutes or equivalent simulated product under normal operating conditions with worst case batch sizes, covering the intended operating range unless development data already confirm it.² |
| Requalification | It stays in a state of control | Evaluation at an appropriate, justified frequency, including the effect of small changes over time.² |
A successful OQ should allow standard operating and cleaning procedures, operator training and preventive maintenance requirements to be finalised.² PIC/S expects PQ to run long enough to cover normal events such as adjustments, stoppages, personnel changes, material replenishment and seasonal variation, with the rationale for the period documented, and to take more samples than routine in-process checks: if those run hourly, “a 15-minute sampling plan may be required”.¹
3How the stages connect.
The order is normal, not fixed. OQ normally follows IQ, but the two may be combined as an installation and operational qualification (IOQ), and PQ may in some cases run with OQ or process validation.² WHO asks for the reason to be justified and documented in the validation master plan or qualification protocol.⁴
Each stage needs an approved protocol with acceptance criteria and a report against them.⁴ Results that fail pre-defined acceptance criteria are recorded as deviations and investigated, and significant changes to an approved protocol during execution are documented as deviations and scientifically justified.² A formal release to the next stage is authorised; conditional approval is possible where open items have a documented assessment of “no significant impact on the next activity”.² WHO adds that equipment is released for routine use only once there is documented evidence that qualification has succeeded.⁴
Suppliers can do part of the work. Annex 15 lets some FAT tests stand without repetition on site where transport and installation do not affect the function, and asks site personnel to confirm vendor protocols before approval.² Under WHO’s guideline, the contract giver remains responsible for qualification done by a supplier or third party.⁴
Effort follows risk. Annex 15 bases the scope and extent of qualification on “a justified and documented risk assessment”.² PIC/S gives an example: an autoclave would likely need more qualification effort than a packaging leaflet insertion machine. It also accepts approaches with different terminology, such as ASTM E2500, provided the result shows the equipment is fit for purpose.¹
4What FDA expects in the US.
The drug CGMP regulations do not name IQ, OQ or PQ; 21 CFR 211 uses “qualified” and “qualifications” only for people.⁶ Section 211.63 requires equipment “of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance”, and 211.160(b)(4) requires instruments to be calibrated under a written programme and not used if they fail their specifications.⁶
FDA’s process validation guidance of January 2011 treats equipment and utility qualification as the first element of Stage 2, process qualification. It covers selecting equipment for its use, verifying it is built and installed to the design specifications, and verifying it operates in all anticipated operating ranges, “under load comparable to that expected during routine production”, including interventions, stoppage and start-up. The quality control unit must review and approve the qualification plan and report.⁷ In that guidance, PQ means process qualification. Its second element, process performance qualification (PPQ), combines the qualified facility, utilities and equipment with trained personnel and the commercial process to make commercial batches, and must succeed before commercial distribution.⁷
5How it runs in Seal.
Seal’s commissioning and qualification workflow links each requirement to its risks, assets, tests, exceptions and turnover decision, so coverage is calculated from those links and shows untested requirements and orphan tests. Executors record actual values, instruments and evidence as they test; a failed acceptance becomes an exception on that requirement, and a retest creates new evidence without overwriting the original failure.
Where a site’s validation plan uses Annex 15’s stages, validation in Seal maps its evidence onto them: installation checks against the configuration as installed, operational cases at limits and worst case, and performance runs linked to their batches. In equipment management, calibration, qualification, cleaning and maintenance evidence connects to the workflow that selects the asset, so a missing prerequisite stops the configured path. Software verification does not replace the physical qualification and calibration the equipment still needs.
References
- 1PI 006-4, Recommendations on Qualification and Validation, PIC/S, 1 October 2026. https:/
/ picscheme. org/ docview/ 11277 (read 6 November 2026) - 2EudraLex Volume 4, Annex 15: Qualification and Validation, European Commission, 30 March 2015, in operation from 1 October 2015. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ 2015- 10_ annex15_ 0. pdf (read 6 November 2026) - 3EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission. https:/
/ health. ec. europa. eu/ medicinal- products/ eudralex/ eudralex- volume- 4_ en (read 6 November 2026) - 4WHO Technical Report Series No. 1019, Annex 3, Good manufacturing practices: guidelines on validation, Appendix 6, Guidelines on qualification, World Health Organization, 2019. https:/
/ www. who. int/ docs/ default- source/ medicines/ norms- and- standards/ guidelines/ production/ trs1019- annex3- gmp- validation. pdf (read 6 November 2026) - 5Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products, Annex 15, Qualification and Validation, EMA/
INS/ GMP/ 163466/ 2026, EMA GMP/GDP Inspectors Working Group, 19 January 2026. https:/ / picscheme. org/ docview/ 11269 (read 6 November 2026) - 621 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211 (read 6 November 2026) - 7Process Validation: General Principles and Practices, Guidance for Industry, Revision 1, FDA, January 2011. https:/
/ www. fda. gov/ media/ 71021/ download (read 6 November 2026)
AQuestions and answers
How does equipment qualification differ from process validation?
Qualification shows that equipment, utilities and facilities are fit for their intended use. Process validation shows that the process, run on that qualified equipment, consistently makes product that meets its specifications. Annex 15 asks for equipment used in process validation to be qualified, and FDA treats qualification as the first element of process qualification.
Can IQ and OQ be combined?
Yes. Annex 15 allows a combined installation and operational qualification, depending on the complexity of the equipment, and PQ can in some cases run alongside OQ or process validation. WHO asks for the choice to be justified and documented in the validation master plan or the qualification protocol.
Can a supplier’s factory acceptance tests replace IQ or OQ?
Partly. Where it is justified and the function cannot be affected by transport and installation, some tests done at the factory need not be repeated on site. Site personnel still confirm that vendor protocols are suitable before approving them, and the manufacturer remains responsible for the qualification.
How often does equipment need requalifying?
There is no fixed interval. Equipment is reviewed at a frequency justified by risk and its criticality, looking at changes, maintenance records, deviations and trends, and the review decides whether more qualification is needed. A series of small changes can add up to a major one, and changes go through change control.
What if equipment already in use was never qualified?
WHO asks for a qualification protocol that verifies the elements of the user requirements, design specifications, operation and performance, with the outcome recorded in a report.
Does FDA require IQ, OQ and PQ by name?
No. The drug CGMP regulations require equipment of appropriate design for its intended use and calibrated instruments, and FDA’s process validation guidance describes qualification activities that cover installation and operation across all anticipated ranges under load comparable to routine production, with the plan and report approved by the quality control unit.