functional tests

ICH Q8–Q10: Equipment qualification, including OQ, must be integrated into a quality risk management approach

When is OQ Required?

• After installation and successful IQ completion
• After significant changes or relocation (Requalification)
• As part of technology transfer or equipment upgrades
• After preventive maintenance if critical parameters were impacted

Components of an OQ Protocol

An OQ protocol is a structured document that defines how to test the operational capability of equipment. Key sections include:

• Protocol Number and Version Control
• Purpose and Scope
• Equipment Description
• Applicable SOPs and Reference Documents
• List of Instruments and Sensors to be Tested
• Functional Test Matrix (parameters, ranges, methods)
• Calibration Verification Steps
• Alarm and Safety Test Plan
• Environmental Condition Checks
• Acceptance Criteria
• Deviation and CAPA Section
• Summary Report Template

Step-by-Step Execution of OQ

1. Verify Calibration Status

• Ensure all measuring instruments are calibrated with valid traceable certificates
• Record serial numbers, calibration dates, next due dates

2. Perform Functional Testing

Each function of the equipment is tested under standard and worst-case conditions:

Parameter	Set Value	Observed Value	Pass Criteria	Status
Temperature	40°C	40.1°C	±1°C	Pass
Flow Rate	10 L/min	9.9 L/min	±5%	Pass
Speed (RPM)	300	298	±2%	Pass

3. Test Control Systems and Interfaces

• PLC/HMI interface responses
• Touch panel functionality
• Control loop behavior and PID tuning
• Recipe management (if automated)

4. Execute Alarm and Interlock Testing

OQ must verify that safety features are fully functional:

• Simulate high temperature to trigger alarm
• Open door during operation to test interlock
• Power loss and system restart checks

5. Validate Software and Programmable Logic (if applicable)

• Test input/output sequences
• Validate automation logic paths
• Review audit trails and event logs (21 CFR Part 11)

6. Reproducibility Testing

Each test should be repeated at least 3 times to confirm consistency:

• Cycle time for valves opening/closing
• Chiller cooling response time
• Repeatability of filling volumes

Acceptance Criteria in OQ

• All functional parameters fall within predefined limits
• Alarm and interlock systems work as intended
• No unplanned deviations during execution
• Software logic behaves per URS (User Requirement Specification)
• All test results are documented and signed

OQ Documentation and Attachments

• OQ Protocol and Test Records
• Calibration Certificates
• PLC Screenshots or Audit Logs
• Equipment Manuals and SOP References
• Deviation Reports and CAPA Records (if any)

OQ and Change Control

Any equipment upgrade, configuration change, or automation software update must be routed through change control. Based on impact, partial or full requalification (OQ repeat) may be necessary.

Tips for OQ Audit Readiness

• Use ink signatures, not pencil or erasable markers
• Cross out errors with single line and initial
• Ensure every data point has initials and date
• Use only controlled forms with version numbers
• Keep calibration and traceability records attached

Conclusion

Operational Qualification is a critical GMP requirement ensuring equipment performance aligns with process needs and regulatory expectations. With well-structured protocols, repeatable testing, validated controls, and robust documentation, your OQ becomes a key compliance enabler and process assurance tool.

Explore ready-to-use OQ templates and example test scripts at PharmaSOP.in or learn more about the complete qualification lifecycle at PharmaValidation.in.

Further References

• FDA Process Validation Guidance (2011)
• EMA Annex 15: Qualification and Validation
• ICH Q9 – Quality Risk Management
• WHO Technical Report Series No. 1019