Glossary

Operational Qualification (OQ)

What is Operational Qualification (OQ)?

Operational Qualification (OQ) is a crucial phase of the validation process for equipment, systems, and facilities in various industries, including pharmaceuticals, medical devices, and manufacturing. It ensures that the equipment or system performs within specified operating parameters, calibrations, and conditions defined by design specifications, regulatory requirements, and quality assurance standards.

Why is OQ critical in the pharmaceutical industry?

Operational Qualification is essential in the pharmaceutical industry to ensure that equipment operates reliably and produces consistent, high-quality products. It helps mitigate risks associated with equipment failure, which can lead to product recalls, regulatory non-compliance, and potential harm to patients. By validating that equipment meets operational specifications, companies can maintain high standards of safety and efficacy in their products. This ensures consistency in performance, compliance with regulations and predictive maintenance of equipment.

What types of tests are conducted during OQ?

Tests performed during Operational Qualification may include:

  • Functionality tests to verify that the equipment performs its intended functions
  • Stress tests to evaluate performance under extreme conditions
  • Calibration checks to ensure measurement accuracy
  • Repeatability tests to assess the consistency of results over multiple runs

What happens if an OQ test fails?

If an Operational Qualification test fails, the deviation is investigated to determine the root cause. Corrective actions may be implemented, which could involve equipment adjustments, repairs, or requalification. The OQ protocol may need to be repeated to ensure that the issues have been resolved and that the equipment can operate as intended.