In a cGMP environment, do you need to calibrate a floor scale if it is moved to a different room?
Question : In a cGMP environment, do you need to calibrate a floor scale if it is moved to a different room?
In this cGMP facility, floor scales are moved from room to room as needed. Do the scales need to be calibrated each time they are moved?
floor scale
Best answer:
Answer by Bobbyp416
Any time a scale is moved, it should be calibrated, along with at least one calibration check every fiscal quarter. The last company I worked for did it that way, and everything was GMP based.
There are a lot of answers to this question ( as anything in cGMP). I guess this scale is used for weighing stuffs associated with critical process. If so, I would say that moving that floor scale to a different room implies even a requalification (or revalidation, according to your company’s policies). Since you have already run a protocol for it, and that protocol is specific to the former room’s temperature, humidity, electricity, etc, you can not just assume it will work the same way when in the new room. Moving scales from room to room doesn’t look like a nice practice in my opinion, specially if you are working with different kind of products in those rooms. How can you be sure you are not cross-contaminating? If this is not your case, don’t worry about it, but if it is, you should have a validated procedure which describes the cleaning and trace testing procedures that assure this piece of equipment will not introduce foreign stuff in the next place where it is used.
To move scales also introduces a risk of damage to the inner delicate mecanisms, no matter how tough are your scales.
Well, all that stuff is not what you were asking. Let’s suppose those scales are used for critical process, let’s also suppose your scales will not originate cross-contamination when moved, and finally, let’s suppose they are carefully moved by competent personnel, the first thing to do is check for stability and leveling, then take yourself a few minutes for what I once heard to be called “verification procedure”. I worked in a facility where scales where “verified” everyday by measuring the deviations between a calibrated weigt and the scale. Those weights represented a 25%, 50 % and 75 % of the full range of that scale. I have been told that some people “verify” their scales every day using a single calibrated weight which is about the average of all the things that are weighed there. Good luck.