1. Purpose

To describe the procedure for performing and documenting Operational Qualification (OQ) of equipment, instruments, and systems to ensure they operate according to defined specifications and intended performance.

2. Scope

This procedure applies to all equipment, instruments, utilities, and systems that require qualification within the facility.

3. Responsibility

• User Department: Provide support during OQ, operate equipment under guidance.

• Quality Assurance (QA): Review and approve OQ protocol and report.

• Validation/Engineering Team: Prepare and execute OQ protocols, record data, and ensure compliance.

4. Procedure

4.1 Preparation

• Draft OQ protocol including test parameters, acceptance criteria, calibration requirements, and safety checks.

• Ensure equipment has passed Installation Qualification (IQ).

4.2 Execution

• Verify utilities (power supply, temperature, pressure, etc.).

• Perform functional checks of equipment components.

• Run equipment under operating ranges and conditions.

• Verify alarms, interlocks, and safety features.

• Record all observations and deviations.

4.3 Acceptance Criteria

• Equipment should operate consistently within defined specifications.

• Any deviations must be investigated and documented.

4.4 Documentation

• Record results in OQ data sheets.

• Prepare OQ summary report including deviations, corrective actions, and conclusion.

5. References

• GMP Guidelines

• WHO Technical Report Series

• ISO/IEC Standards

6. Abbreviations

• OQ: Operational Qualification

• IQ: Installation Qualification

• PQ: Performance Qualification

• SOP: Standard Operating Procedure