Can anyone in the regulated parts of the chromatography business give some hints as to how you do change-control for complex, multipart systems (different pumps, injectors, detectors, etc). In our GLP lab, we have LC-MS/MS's that combinations of different manufacturers' equipment and we would like to get some idea how others do this. In addition, how would one do an instrument use log book if one has a system such as this, with multiple, switchable components.

Your help is greatly appreciated.

Chris,

If this is a regulated environment, with instrument qualifications performed at regular intervals, you really should not be switching components around in your systems. In theory, when an instrument, or a component, is moved, it should be requalified. Even if it is only down the bench or across the aisle. For your books though, make the book specific to the configuration, and then do not change that configuration(since you should not anyway)

Hi Chris,

Using a system composed of parts from many different manufactures would not pose a problem. Our approach would be to validate the system to the manufactures as new spec for the individual components. Flow accuracy and precision, gradient accuracy, etc. for the pump and so on.

It is more difficult if you want to switch in and out components. We don't do this too much. We define and document a set of components as a system then log use of the system not the components.

We have a validated laboratory equipment change control SOP and forms for controlling system configurations.