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Requalification after moving HPLC systems to another lab

Posted: Thu Oct 01, 2015 8:46 am
by dimitrije
Dear all,

We plan to move laboratory instruments to new QC building (HPLC/UPLC, GC and other). Is it necessary to perform complete IQ/OQ/PQ after the moving to the new lab. If it is not necessary, is it enough to perform some functionality test (repeating of the last analyses on the same systems after the moving is done).
1. In our case, some of the instruments will be requalified immediately after moving since the regular qualification interval is close to the date of moving.
2. Some of the equipment will be qualified couple of months before moving to the new lab-the question is – Is it enough to have only IQ after the moving is done or it is necessary to perform IQ /OQ and PQ again?
3. Some of the equipment has the regular qualification date 6 months after the moving date– Is it enough to have only IQ after the moving is done and then to wait the date of regular qualification?

Thank you all

Re: Requalification after moving HPLC systems to another lab

Posted: Thu Oct 01, 2015 2:51 pm
by KM-USA
I don't know he real answer, but my boss would say "any move", and 6 years ago we moved into a new lab 3 miles down the road and instrument service company moved and requalified everything.

Of course, does "any move" include sliding the system down the bench? Moving to a bench across an aisle? What if I rotate a module to get at its rear connections?

Of course, some have the opinion that passing System Suitability demonstrates that the system is suitable for the analysis. I remember one expert stating "what part of suitable do you not understand?".

Re: Requalification after moving HPLC systems to another lab

Posted: Thu Oct 01, 2015 4:25 pm
by Blazer
I'm not aware of any particular regulation for this. The safe answer is to repeat everything, obviously. If you have some other document that shows that the new lab space will have the same electrical and environmental conditions as the old lab, you can probably bypass the IQ and just reference that document.

In the end, it probably comes down to budget. Depending on how many instruments you're moving and how much was allocated for relocation and requalification, it would be cleanest to simply repeat the qualification work. The vendor will likely do this for you at a nominal cost.

Re: Requalification after moving HPLC systems to another lab

Posted: Mon Oct 05, 2015 2:08 pm
by DR
If it is not, this should be covered by your SOPs, which are the arbiter of what should be done and when.

Re: Requalification after moving HPLC systems to another lab

Posted: Sat Feb 25, 2017 5:42 am
by mirac_han
I think you must do all qualification activity,
For examble, optical bench (uv detector) is very sensitive, how do you trust transportation activity, in mw experience, we transfer our hplc to another bench and we did not examine electrical and other envirimental stiuation. At the end of day our hplc autosampler cooler mainboad is down.