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Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.
Q: We are a newly established small company, and we would like to understand the principles of equipment qualification. Can you give us some essential guidance?
A: Equipment must be fit for use, and to prove this within the realm of your quality system, you need to qualify the equipment. Equipment may consist of mechanical parts or it may be a system that is made up of mechanical parts and automation (software).
It all starts with your user requirement specification. Unless you describe what you want (need) and how you want to use the system, it will be impossible to perform qualification. Let us take the example of a mixer. At what speeds and temperatures and for what length of time do you intend to use the mixer? Do you require preset programs, alarms, power supply of a specific voltage, polished stainless steel surfaces, specific dimensions of the mixing paddle, etc.?
Once you know what you need, you can prepare the qualification plans and protocols (these can be one document). These documents describe what you want to test, who will perform the testing, how the tests have to be performed and how results have to be documented. The mixer may come with 50 pre-installed mixing programs. It is probably unnecessary to test them all, and sometimes it is not possible to test 100%. In these cases, you describe your rationale for selecting a limited number of test cases. Do you need to test at all? In principle yes, because with any delivery and installation, something can go wrong, such as missing connections, incorrect software version, wrong version of the user manual, etc.
If your test plans contain tests that have no related user requirement (perhaps you verify the color of the mixer), you can certainly document these items; but remember, you cannot pass or fail the result. It just is what it is.
Crucial to qualification is documentation (i.e., documented evidence). An example of insufficient evidence would be if the test checks that the mixer can be run for 60 minutes without overheating and all you document is:
Test: ‘Verify that the mixer does not overheat after 60 minutes of mixing at full load.’
Test result: ‘Test passed’.
You need to also document the type of load (e.g., sugar syrup with a viscosity of xyz), the mixing speed (e.g., 10 rpm setting on the mixer), how the time was measured (e.g., stopwatch), and how it was proven that the mixer did not overheat (e.g., alarm 12 ‘overheating’ did not show and stop the mixer). That will then be documented evidence that satisfies the regulators.
This is of course just a very high-level summary of qualification basics, but it should give you something to start with.
Siegfried Schmitt is vice president, Technical at Parexel.
Volume 35, Number 11
When referring to this article, please cite it as S. Schmitt, “Principles of Equipment Qualification,” BioPharm International 35 (11) (2022).