Equipment qualification is documented evidence that an instrument or piece of equipment functions according to its operating specifications. Validated, or “qualified”, equipment forms another layer of confidence of generating accurate and reproducible results. Each equipment type has its own unique set of validation requirements to ensure it performs according to the manufacturer’s specifications and is repeated on a planned recurring schedule. Below are the fundamental components to equipment validation (also referred to as qualification).
Documented collection of activities to establish that an instrument was delivered as specified, was properly installed, and the environment is suitable for use.
This is the first step to any instrument qualification.
Documented evidence demonstrating the equipment will function according to its operational specifications, which may be defined by the instrument manufacturer or according to the process requirements.
OQ tests drive down to the core of the operation of the individual components that make up an instrument. Complex instruments such as HPLC’s and GC’s have several different functions contained within the entire system. The OQ tests each function independently.
Documented evidence that performance testing on all components that comprise the entire system meet the specifications defined in the qualification protocol.
The PQ tests the system as a whole. This means that hardware, the software, and accessories that comprise the instrument are tested as a single unit in a holistic approach.
If an instrument has gone through a repair of any sort, it’s not enough to simply repair it and put it back into service; a major deficiency in a truly compliant laboratory. There must be a strategy to requalify the instrument to demonstrate it’s back to operating as intended. Equipment breaks, it’s just the nature of the beast. After repair, qualification must be re-established to assure the system is back to meeting the manufacturer’s specifications.
Planned preventative maintenance is a fundamental procedure to ensure optimum instrument performance and extends the life of the equipment. Preventative maintenance is typically executed immediately preceding the scheduled OQ/PQ.