Certified Pharmaceutical GMP Professional Practice

What does Operational Qualification (OQ) demonstrate?

1. That a product meets predetermined specifications

2. That the equipment operates according to its design specifications

3. That premises are built according to GMP standards

4. That a system is validated for compliance

The correct answer is: That the equipment operates according to its design specifications

Operational Qualification (OQ) is a critical phase of the validation process in the pharmaceutical and biotechnology industries. It specifically focuses on verifying that the equipment and systems function as intended and according to their design specifications in a controlled environment. This involves testing the equipment's performance under normal operating conditions to ensure that it operates consistently and reliably. By demonstrating that the equipment operates according to its design specifications, OQ confirms that the systems can perform their intended functions effectively and will consistently produce quality products, thus establishing a foundation for further phases of validation, such as Performance Qualification (PQ). The other options address different aspects of quality and compliance. For instance, meeting predetermined specifications relates more to the product qualification phase rather than the operational capability of the equipment. Compliance with GMP standards concerns the broader aspects of facility and process validation and would not be limited to just the operational functions of specific equipment. Finally, system validation for compliance encompasses various validation stages, including Installation Qualification (IQ), OQ, and PQ, rather than being solely representative of OQ.