Can anyone define these ple........ase??? I always confuse between OQ and calibration Is there any difference between these two.

Any help will be highly appreciated.

Thanks

Sean

This material was lifted directly from the Waters web site at www.waters.com. Go there and read it all, there is much more.


Installation Qualification (IQ)
The IQ process can be divided into two steps, preinstallation and physical installation. During preinstallation, all the information pertinent to the proper installation, operation and maintenance of the instrument is reviewed. Site requirements and the receipt of all of the parts, pieces, manuals, etc., necessary to perform the installation are confirmed. During physical installation, serial numbers are recorded, and all of the fluidic, electrical, and communication connections are made for components in the system. Documentation describing how the instrument was installed, who performed the installation, and other miscellaneous details should be archived.

Operational Qualification (OQ)
The OQ process ensures that the specific modules of the system are operating according to the defined specifications for accuracy, linearity and precision. This process may be as simple as verifying the module self diagnostic routines, or may be performed in more depth by running specific tests to verify, for example, detector wavelength accuracy, flow rate or injector precision.

Performance Qualification (PQ).
The PQ step verifies system performance. PQ testing is conducted under actual running conditions across the anticipated working range. In practice, however, OQ and PQ frequently blend together, particularly for linearity and precision (repeatability) tests, which can be conducted more easily at the system level. For HPLC, the PQ test should use a method with a well-characterized analyte mixture, column, and mobile phase. It should incorporate the essence of the System Suitability section of the general chromatography chapter in the USP. Again, proper documentation should be archived to support the PQ process.