This report provides guidance on equipment qualification (EQ) of high performance liquid chromatography (HPLC) instruments. Equipment Qualification is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use. The guidance defines a general approach to EQ based on four stages of qualification: Design Qualification (DQ); Installation Qualification (IQ); Operational Qualification (OQ); and Performance Qualification (PQ).
The guidance was prepared by LGC in collaboration with the VAM Instrumentation Working Group, a committee comprising a cross-section of users, suppliers and manufacturers of analytical instruments along with representatives of regulatory authorities and accreditation bodies.