Equipment IQ OQ PQ Protocol Template
Qualification protocols prove that a piece of equipment is fit for use before it makes a batch. This template gives you the usual IQ, OQ and PQ structure with test tables and approval lines so you can start writing the real content.
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Equipment IQ OQ PQ Protocol Template
Qualification Protocol
Company: Acme Pharma Ltd Protocol no.: VP-CP0102-001 Equipment: Tablet coating pan (CP-0102) Manufacturer / model: VendorCo CP-150 Location: Coating Room 2.07 Date: 2026-10-20
1. Purpose and scope
This protocol defines the tests that will demonstrate Tablet coating pan is installed correctly, operates within its specified ranges and performs consistently for its intended use. It links to the user requirements and the risk assessment for the equipment.
2. Operating range
Pan speed 2 to 12 rpm, inlet air temperature 40 to 70 C, spray rate 20 to 150 g/min.
3. Installation qualification (IQ)
| Test | Acceptance criterion | Result | Pass/Fail |
|---|---|---|---|
| Equipment matches purchase order and drawings | Model, serial number and options as ordered | ||
| Utilities connected and verified | Voltage, compressed air, steam, water as specified | ||
| Materials of construction | Product contact parts per certificates | ||
| Instrument calibration | Calibration certificates in date and traceable | ||
| Documentation received | Manuals, drawings and software versions on file |
4. Operational qualification (OQ)
| Test | Acceptance criterion | Result | Pass/Fail |
|---|---|---|---|
| Alarm and interlock function | Each alarm triggers at the set point | ||
| Control accuracy across operating range | Within specified tolerance at low, mid and high set points | ||
| Power failure and recovery | Equipment recovers to a safe, defined state | ||
| Access levels and audit trail (if computerised) | Roles and logs work as designed |
5. Performance qualification (PQ)
| Test | Acceptance criterion | Result | Pass/Fail |
|---|---|---|---|
| Consecutive runs with representative load | Three runs meeting product specification | ||
| Cleaning verification after use | Meets approved cleaning limit |
6. Deviations and conclusion
List every deviation with its number, impact and closure. State the overall conclusion on whether the equipment is fit for its intended use.
Approvals
A structure for your own protocol, not a validated document. Acceptance criteria must come from your user requirements and risk assessment. Follow your validation master plan and applicable guidance such as EU GMP Annex 15.
Qualification status inside your ERP
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How to use the template
Fill in the equipment details and the operating range, then export to Word. Replace the generic tests with ones from your user requirement specification and risk assessment, and give each test a number you can trace to a requirement. Approve the protocol before executing it. During execution, write results in ink or in a controlled electronic form, and record each deviation as it happens.
- Approve the protocol before any test is run
- Trace each test to a requirement in the URS
- Record actual values, not just ticks
IQ, OQ and PQ in plain terms
Installation qualification shows the equipment is what you ordered and is installed correctly, with the right utilities and calibrated instruments. Operational qualification shows it works across its stated ranges, including alarms and interlocks. Performance qualification shows it performs consistently under real conditions with representative material. EU GMP Annex 15 and FDA process validation guidance describe the approach, and both expect a risk based, documented rationale for the depth of testing.
Common mistakes
Frequent problems are copying a vendor factory acceptance test and calling it OQ, testing only at one set point, and closing deviations without impact assessment. Computerised equipment also needs checks of data integrity features, such as user roles and audit trail. Finally, remember that qualification is not the end: keep the equipment in a calibrated and maintained state, and requalify after significant change.
- Test the extremes of the range, not only the middle
- Include cleaning and sampling in the PQ where relevant
- Link the qualified status to the equipment record in your ERP or CMMS
Frequently Asked Questions
Do all equipment need IQ, OQ and PQ?
Not necessarily. Depth depends on risk and use. Simple non critical equipment may need only IQ and a function check, while critical process equipment needs the full set. Document the rationale in your validation master plan.
Can I reuse the vendor's test as OQ?
You can leverage vendor documentation if it is assessed and covers your requirements, as Annex 15 allows. You still need to show it applies to your installed equipment and fills any gaps with your own tests.
What is the difference between OQ and PQ?
OQ tests function across operating ranges, often without product. PQ demonstrates consistent performance with representative materials, load and conditions. In some programmes PQ is combined with process validation runs.
When do I requalify?
After significant change, relocation, major repair, or at a periodic interval set by your risk review. Many sites use change control to decide if requalification is needed.
If qualification status needs to block production orders or maintenance plans in your ERP when it lapses, Netray can help connect the two.
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