Equipment Qualification
It is a basic requirement of good analytical chemistry that balances and other analytical instruments must be suitable for the purpose for which they are used and that they must be appropriately calibrated. As a consequence, Equipment Qualification is gaining more and more importance in ensuring the validity of results.
Regulatory bodies also seem to be turning their attention increasingly to this area, and manufacturers of analytical equipment are forced to play a significant role in the various steps of Equipment Qualification.
Types Of Equipment Qualification
Design Qualification(DQ)
Design qualification (DQ) is the process of completing and documenting design reviews to illustrate that all quality aspects have been fully considered at the design stage. The purpose is to ensure that all the requirements for the final systems have been clearly defined at the start.
DQ should ensure that instruments have all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet user requirements.
Installation Qualification(IQ)
Installation qualification (IQ) is the process of checking the installation, to ensure that the components meet the approved specification and are installed correctly, and to see how that information is recorded.
Installation Qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.
Operational Qualification(OQ)
Operational qualification (OQ) is the process of testing to ensure that the individual and combined systems function to meet agreed performance criteria and to check how the result of testing is recorded.
The purpose is to ensure that all the dynamic attributes comply with the original design. Each of the instrument’s function are checked to ensure that they conform to the manufacturer’s specifications.
Performance Qualification(PQ)
Performance qualification (PQ), also called process qualification, is the process of testing to ensure that the individual and combined systems function to meet agreed performance criteria on a consistent basis and to check how the result of testing is recorded.
The temperature sensor readings are compared with a certified reference thermometer. After calibration, the conductivity sensor readings are compared using certified, traceable control standards.
