Is Testing Equipment Re-Validation required if the Test Equipment is Relocated?

T

Tiffany

#1
Hi mates,

One of the re-validation are required for all machines (for production use) if these machine are re-located. Is these also applied for testing equipment?

As this is happened due to the functions re-location from 1st floor to 3rd floor, this testing equipment were re-locate, any re-validation required? Which document in US FDA regulations or other regulations stated this and is there any guidelines can be referring to?

:thanx:

Tiff
 
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R

Rob Kellock

#2
If you move test equipment it makes sense that it be at least revalidated, in some cases it should be recalibrated. Obviously the lengths you go to will be dependent on equipment and the risk associated with the tests.

Imagine relying on a piece of test equipment for measuring your products. If the test equipment is out, the measurement is no longer valid and therefore you may be supplying products which are wrong. This wouldn't be a good result against any requirements whether they be dictated by the customer, a standard or legislation.
 
I

isoalchemist

#3
We get into a language issue on what exactly we mean by revalidated and your industry. Should the system be revalidated / recalibrated to ensure it is functioning correctly in its new location Yes, you need to know it was not broken in the move. Should the system be revalidated to prove it is capable of making the measurement required, No the move won't change its capability if it is working properly.
 
R

Rob Kellock

#4
And how do you know if it's working properly unless you validate / calibrate it? I'm not sure this is a language issue, unless you mean understanding the term 'validation'.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi mates,

One of the re-validation are required for all machines (for production use) if these machine are re-located. Is these also applied for testing equipment?

As this is happened due to the functions re-location from 1st floor to 3rd floor, this testing equipment were re-locate, any re-validation required? Which document in US FDA regulations or other regulations stated this and is there any guidelines can be referring to?

:thanx:

Tiff
21 CFR part 820:

Sec. 820.72 Inspection, measuring, and test equipment.

(a)Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.

(...)
(emphasis added)

Should you re-validate? I think so. What should be the extent of the re-validation activity? Start off with a risk analysis, and continue from there. For example, let's say that you have a piece of testing equipment that is very vibration-sensitive. Now, on the 1st floor there were no issues because vibration was below any effective threshold, as shown through your original validation. On the 2nd floor you have a machine that causes just enough vibration felt on the 3rd floor to cross the threshold, so now you do have a testing issue (just an imaginary scenario to make a point).

Perhaps the risk analysis will show that very little is required to maintain that the accuracy and fitness are not likely to be significantly affected, but at least you will have it sorted and documented.

Cheers,
Ronen.
 
M

Murphys Law

#6
Is sort of depends on your test. Is it a big complex test environment that requires infrastructure or something portable.

Ronen touched upon the vibration example I was going to use. Another that I remember on a site move, was water pressure differences.
 
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