Equipment Mobility - Transfer of manufacturing lines to a different location

#1
Hi covers,

We are performing transfer of manufacturing lines to a different location and as part of that we need to perform IQ, OQ, and PQ activity.

Right now we are at IQ stage. As a QE, I had a discussion with ME and Cal. team as to what equipment mobility requires. We are not quite clear on this one.

Any experienced Covers can shed some light on this one?

Also, our WI says we need to perform pre and post move calibration if we find the equipment non-mobile.

Thanks in advance for your input
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Not medical, but my bet is it's essentially the same if the equipment not mobile (e.g. big surface plates) in that everything has to go through IQ, OQ, and PQ: PPAP Clarification - Tooling Transfers

Not to mention the location of the equipment - Is it used on the line? A small controlled environment lab?

Hopefully an "FDA type" person can correct me if I'm wrong.
 
#3
Not medical, but my bet is it's essentially the same if the equipment not mobile (e.g. big surface plates) in that everything has to go through IQ, OQ, and PQ:
Not to mention the location of the equipment - Is it used on the line? A small controlled environment lab?

Hopefully an "FDA type" person can correct me if I'm wrong.
It is used on a line.

We are having multiple discussions regarding mobility and its link to Calibration.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I'm not aware of an FDA guidance for moving facilities. I think you'll have to treat the new facility as a brand new one. This is just my general knowledge - I haven't researched it lately and I don't have direct experience in a similar situation.

Cheers,
Ronen.
 
M

Metron

#5
Has a change control been initiated?
This should have all been captured within this document.
I assume all calibrations were performed pre-move to assure any processes performed at its original location were done with a qualified, calibrated unit.
once moved/ installed an additional post-move calibration would be required along with a full qualification.
this assures all aspects of the unit are operational in its new location.
 
A

albridgeuk

#6
The regulators expect you to validate once you are re-sited. You can mitigate this by using a risk assessment to define exactly what will or will not be affected by the move. However, it is often best practice to revalidate.

Pre-calibration is usually only done to give you confidence that the item is currently serviceable. It does not assist in any other way and is not mandatory.
The only difference between portable and static item calibration is the periodicity between calibrations.

Static items mounted to robust worktops (surface plates, dead weight testers, etc) can actually be extended to 5 years between calibrations. There again fragile test instruments can require pre-use calibration.
It is up to the user to build up the calibration history data, and use that as justification for progressively extending (or reducing) the periodicity of calibration. That is the set up the regulators look for.

Moving qualified equipment means qualifying the new site;
Utility loadings - RFI freedom - EMI freedom - Climatic conditions - access product - access personnel - cross contamination possibilities.
Then all the rest of the equipment functionality tests and inspections.

Alex
 
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