Testing & validation
IQ / OQ / PQ
The qualification stages regulated manufacturers use to prove equipment is installed, operates and performs as intended.
Installation, Operational and Performance Qualification
- Category
- Testing & validation
- Scope
- Industry practice
- Edition / refs
- EU GMP Annex 15 · FDA Process Validation Guidance (2011) · ISPE GAMP® 5 · ASTM E2500
MSA output
- IQ/OQ/PQ validation protocols
- Test certificates & sign-off documentation
- NCR register
What is IQ / OQ / PQ?
IQ, OQ and PQ are the stages of equipment qualification used in regulated industries such as pharmaceuticals, biotechnology, medical devices and food. Installation Qualification verifies that equipment is installed as specified. Operational Qualification verifies that it operates as intended across its specified operating ranges. Performance Qualification verifies that it performs consistently under routine production conditions.
Qualification is not defined by a single standard. Key references include EU GMP Annex 15 (Qualification and Validation), the FDA Guidance for Industry on Process Validation (2011), ISPE GAMP® 5 for computerised systems and ASTM E2500. Qualification normally follows a user requirements specification (URS) and design qualification, and may reuse justified FAT and SAT results.
Who it applies to
- Machine builders and OEMs supplying regulated manufacturers
- Integrators of process, filling and packaging lines
- Validation and quality assurance engineers
- End users qualifying new or modified equipment
Key requirements
- 01
Requirements traceability
Trace every user requirement to a design element and a test.
- 02
Pre-approved protocols
Protocols with defined acceptance criteria, approved before execution.
- 03
IQ
Verify installation, components, drawings, utilities, calibration and documentation against specification.
- 04
OQ
Test functions, alarms, interlocks and operating ranges, including worst-case conditions.
- 05
PQ
Demonstrate consistent performance with production materials and conditions.
- 06
Deviations and approval
Record deviations, resolve them with documented rationale and sign off the final reports.
Summary for orientation only. Always refer to the current official text of IQ / OQ / PQ and any applicable legislation.
MSA for IQ / OQ / PQ
What MSA generates
Evidence produced from your engineering inputs, traceable end to end and exported to Word, PDF or Excel.
IQ/OQ/PQ validation protocols
Protocols generated from your requirements and system models, with acceptance criteria.
Test certificates & sign-off documentation
Execution records and approvals in one traceable package.
NCR register
Deviations and non-conformances tracked to close-out.
Frequently asked questions
Is IQ/OQ/PQ required by law?
GMP regulations require regulated manufacturers to qualify equipment, but they do not prescribe a document format. IQ/OQ/PQ is the established way to structure that evidence.
Can FAT and SAT results be reused in IQ and OQ?
Yes, where justified. EU GMP Annex 15 and ASTM E2500 allow testing performed at FAT or SAT to be leveraged, provided it is documented and the functionality is shown not to be affected by transport and installation.
How does qualification relate to machinery safety validation?
They have different goals — product quality versus personal safety — but overlap on interlocks and alarms. Keeping both traceable to the same engineering data avoids duplicated or conflicting tests.
Generate IQ / OQ / PQ evidence from your own data
See how MSA turns your requirements, drawings and process data into certification-ready documents — fully offline.