IQ, OQ, PQ and process validation: who proves what
Qualification proves the equipment. Validation proves the process. Either way, the manufacturer plans, runs and approves the work.
In Short
- PQ normally follows successful IQ and OQ.
- FDA: design, qualification, continued verification.
- Your quality unit approves the results.
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
- Who decides, and who may not
- Supplier to finished bulk
- Test, review, investigate
- Packs, serialisation and recall
Plus Evidence map and four worksheets.
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UltimateFree guide
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
Qualification shows equipment and systems are installed and work as intended. Process validation shows the manufacturing process consistently makes quality product. FDA's 2011 process validation guidance and EU GMP Annex 15 are the main public references. Both are guidance under binding GMP law. Sources were checked on 2 Oct 2026.
Qualification versus Validation
IQ checks installation against the approved design, OQ checks operation across the intended ranges, and PQ checks performance under routine conditions. Annex 15 says PQ should normally follow successful IQ and OQ.
Who does what
| Step | What it shows | Who approves |
|---|---|---|
| IQ | Installed as designed | Your quality unit |
| OQ | Operates across intended ranges | Your quality unit |
| PQ | Performs under routine conditions | Your quality unit |
| Process validation | The process consistently makes quality product | Your quality unit |
- IQ
- What it shows
- Installed as designed
- Who approves
- Your quality unit
- OQ
- What it shows
- Operates across intended ranges
- Who approves
- Your quality unit
- PQ
- What it shows
- Performs under routine conditions
- Who approves
- Your quality unit
- Process validation
- What it shows
- The process consistently makes quality product
- Who approves
- Your quality unit
More on qualification versus Validation
Process validation is about the product and process, not one machine.
FDA's Three Stages
FDA's January 2011 guidance describes Stage 1 process design, Stage 2 process qualification (including process performance qualification) and Stage 3 continued process verification. Validation continues through commercial manufacture.
FDA's Three Stages
- Stage 1Process design: build process knowledge and a control strategyDevelopment
- Stage 2Process qualification, including process performance qualificationManufacturing, QA
- Stage 3Continued process verification during commercial productionManufacturing, QA
Who owns the decisions
The manufacturer plans, runs and approves qualification and validation. Suppliers can provide evidence and support, but the manufacturer's quality unit decides whether results are acceptable.
Computerised Systems
Software used in GMP work is validated for its intended use. The supplier's evidence can reduce effort, but the user decides the approach and approves the outcome.
Where V5 fits
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote. Your team plans, runs and approves intended-use validation and PQ as applicable.
More on where V5 fits
V5 records batches, laboratory results and trends that can feed continued process verification.
Also relevant: Enterprise Deployment & Validation Planning Guide (13-page PDF, on the On-Premises page).
Questions
What is the difference between IQ, OQ and PQ?
IQ confirms installation, OQ confirms operation across intended ranges, and PQ confirms performance under routine conditions. Annex 15 says PQ normally follows successful IQ and OQ.
What are FDA's three stages of process validation?
Process design, process qualification and continued process verification, as described in FDA's January 2011 guidance.
Does V5 provide PQ?
No. Enterprise includes IQ/OQ and validation support, scoped in your quote. Your team plans, runs and approves PQ as applicable.
Is software validation the same as process validation?
No. Software is validated for its intended use; process validation shows the manufacturing process consistently produces quality product. Both are owned by the manufacturer.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
