Certified Pharmaceutical GMP Professional Practice Exam 2025 - Free GMP Practice Questions and Study Guide

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.