Cal. check after repair/replacementComponent or whole thing?

[DR]

We had an electrical "problem" that nuked a UV detector on one of our LCs. Upon replacing the detector, a debate ensued between our R&D staff & our QA person. QA thinks that the entire calibration SOP needs to be done on the system (it's about half way to the next scheduled check-up). The rest of the staff wants to qualify the detector per that portion of the SOP only (check wavelength accuracy, lamp energy, that it sends a signal to the CDS).

It's a Pharma R&D lab that occasionally has to do some release testing for support of clinicals (B.E. stuff).

Opinions?

[Consumer Products Guy]

I'd do the detector only, and document that. Why re-do pump flow rate, mixing accuracy, etc.?

[lcguy1]

I guess it would depend on how the SOP's are written. Do you have a section which spells out what has to be done after different types of repairs? If not, it may be a good idea to put that kind of section into the SOP's you write/revise. In our lab, replacement of a board or electrical component would be just testing the detector wavelength accuracy, linearity, and communication with the data system. It does not affect the pumps or autosampler, so why test them too?

[tom jupille]

In the past, I have heard FDA people say (in public) that the ultimate qualification is the system suitability requirements for the method that you are running. In effect, if you meet system suitability, the system is suitable (a bit of a tautology there!). In effect, so long as your SOPs allow it, you could swap in a whole new detector. So long as you meet system suitability, you're "good to go". I'll agree with lcguy1 on SOPs, though: it is a good idea to have this policy documented ahead of time.