Operational Qualification (OQ) is usually performed once or periodically to confirm that an instrument is fit for use. As described in USP <1058>, “OQ tests can be modular or holistic… After successfully completing OQ, and prior to placing the instrument or system into routine operation, the qualification must be approved by the quality unit and management.” OQ provides a thorough evaluation of a new instrument’s design, performance limits, and characteristics before it is put into service.
Performance Qualification (PQ) is defined as “the documented collection of scheduled or ad hoc activities necessary to demonstrate that an instrument or system, in routine operation, consistently meets user-defined specifications and is suitable for its intended use.”
The HPLC kit performs an extensive PQ, covering all critical instrument functions.
To learn more about our PQ kits, please follow this link.
