Calibration before and after relocation of GMP manufacturing equipment

jkuil

Quite Involved in Discussions
Are there any guidance documents specifying when relocation of GMP manufacturing equipment (e.g. freezers, refrigerators, balances, test equipment, etc) requires calibration before and after the move (within a site)? Or do you have your own criteria? What risks do you identify?
Some equipment is sent off site to a contract laboratory for calibration. But frequently procedures require calibration of equipment or measuring devices when relocated within the site.
 

Marcelo

Inactive Registered Visitor
Which type of equipment would you not necessarily recalibrate.

In principle, all of them. I would say that you need to check for the calibration of all equipment which an analysis show that it may loose the calibration status during relocation (or you can do this to each equipment to be on the safe side, if possible). Then, it would need to recalibrate only the ones that the check shows that the calibration was lost.

Or you analysis could identify the need to recalibrate some anyway, again just to be on the safe side.

But, the point is, these are your decisions, your criteria.
 
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Hershal

Metrologist-Auditor
Trusted Information Resource
I would definitely recalibrate balances.

Balances should always be calibrated where they are used, and if moved then recalibrated. If they are four place right of decimal, or more, they should never, ever, be moved absent some real need.

The greater the resolution of the balance, the more sensitive it is.

Hope this helps.
 

Charles Wathen

Involved - Posts
We have documents in place (EQPs) or equipment qualification protocols. Inside these documents, it describes what happens when equipment is moved - if it requires calibration or not. For example, if we move a table top oven from one line to another line on the same floor and in the same room, calibration is not required. If the same oven is moved to another building, then it would require a pre-calibration and a post calibration.

What is nice about this method is if the oven is found within tolerance before the move, but found OOT after, we would not issue an OOT report. It would simply be re-calibrated and returned to service.

Other equipment, such as balances as Hershal mentioned, that is an automatic calibration anytime it's moved, even if just a few feet for precision balances that have more than 4 digits of resolution.
 

BradM

Leader
Admin
If I were you, I would initiate a move plan, and outline the level of Change required.

The equipment requiring calibration will depend on the installation qualification. If the equipment is qualified to be portable (thermometer, gauges, etc.), then calibration may not be needed. However, everything else may need some level of verification pre-post.

For me, scales, balances, centrifuges, flow hoods, and most analytical should be calibrated/verified pre-post move.
 
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