how the hplc instrument is validate n caliberated?
2 approaches exist, both using the traditional 4Q approach. for the purposes of the thread I will focus on the OQ/PV. One approach is to do component testing (pump accuracy and linearity; detector wavelength accuracy and asborbance linearity, injector accuracy and linearity, proportioning valve accuracy and linearity, vial position sensor accuracy, column heater/cooler accuracy and linearity, sample heater/cooler accuracy/linearity, etc) and then do a PV using a standard solution and running a sample. Typically this would consist of a repeatability and linearity section. This approach is time-consuming and can be subjective.
The other approach utilises a system testing approach as opposed to testing components. This makes use of standard solutions using different methods which accounts for all the above components using established chromatographic criteria such as k’, R, etc to prove that the individual components, when interacted, all provide a consistently good chromatographic response, thus indirectly testing said components. Items tested during such an automated run include all the components mentioned above, but is performed over a shorter period of time and eliminates any subjectivity on the part of the validation analyst. the only manual tests performed are the temperature accuracy checks on the column heater/cooler and sample heater/cooler modules.
All the above assumes that the software running the LC has already been validated.