3 Risks to Your Laboratory Equipment’s Qualification Status

When risks are mentioned, they usually refer to risks related to safety, quality, or data. Rarely, is the reference to risks related to the qualified status of laboratory equipment. However, the results that the particular equipment produces are only trustworthy if the equipment maintains a qualified status. This means that in the absence of proof equipment qualification, your results may be in doubt. Furthermore, your equipment must be qualified for validated processes. If this is not or not anymore the case, the validated process is also at risk.

In this article, we will look at the factors and situations that may lead to the suspension of the qualification status of laboratory equipment. First, I will explain how lab equipment achieves qualified status. Then I will delve into common risk factors that may cause the equipment to lose its qualified status.

What is equipment qualification?

Qualification is the provision of documented high-quality evidence that a piece of equipment or a specific environmental status has met predetermined specifications and quality characteristics, demonstrating its suitability for the manufacture of a pharmaceutical product. This means the equipment’s components have been defined and tested to show the equipment meets the user’s requirements. All data required for this process must be meticulously documented.

Required documentation includes:

• Identifying information, including manufacturer serial numbers, for all components of the equipment, such as UV/Vis, autosampler, PC, and printer, and how they are connected (e.g.: PC USB port 2 connected to a printer);
• Software data, including the exact name and version of firmware and/or software, used;
• The exact location of the equipment’s installation, including the building, floor, room, and space;
• User settings on the equipment and firmware/software, as well as frequency, rotation speed, and other parameters that are important for the process or measurement; and Calibrations data, including the calibration ranges (e.g., 80-120°C).
• This data should be collected during the Installation Qualification (IQ) phase, defined by EU GMP Guidance Annex 15 as the “documented verification that facilities, systems, and equipment, as installed or modified, conform to the approved design and manufacturer’s recommendations.”

The IQ phase is complete once the system has been verified, with all the above data documented. Any change should be mapped via a Change Control process, which ensures qualified representatives have evaluated the change for its potential impact and determined the arrangements necessary to demonstrate and document compliance.

When does the qualified status cease to exist?

Any changes that have not been documented via a Change Control process will result in the suspension of the equipment’s qualified status. There are only a few exceptions to this. For instance, changing the power connection in the switched-off state from socket A to socket B does not cause any suspension of the qualified state. However, changing a component from one data-transmitting connection to another would suspend qualification. In other words, whenever the documented status no longer corresponds with reality, the qualified status is suspended, whether or not the equipment meets the requirements. This requires that the equipment’s current state is accurately documented at every step.

Risk factors for equipment’s qualification status

1. Documentation gaps
   The documentation effort of laboratory equipment qualification is often underestimated. Even the supplier-manufacturer qualification should be thorough enough to establish the manufacturer’s credibility. Many test points in the phases of equipment qualification (DQ, IQ, OQ, PQ) are based on tests performed by the manufacturer. Any questions about the manufacturer or supplier could cast doubt on the tests they perform.

2. Routine maintenance and manufacturer updates
An IT technician’s insufficient understanding of GMP and the state of qualification is one of the greatest risks to the equipment’s qualified state. Technicians usually tend to focus only on the technical reasons for their actions. As a result, they may install firmware or software updates before documenting the qualified status of a given piece of equipment. It is worth noting, however, that even plugging in the technician’s computer could introduce cybersecurity issues.

It should be emphasized that firmware or software updates represent Change Control-required changes. A failure to document these changes breaks the equipment’s qualified status. It is also necessary to ensure that technicians do not make in-process changes to the firmware or software. It might be useful to get written confirmation that the technician has been informed about this.

Another potential risk comes from manufacturers’ automatic updates, which are installed with an Internet connection. These should be deactivated whenever possible.

3. Personnel
Laboratory personnel must also be considered a significant risk factor. It is crucial that all laboratory employees have awareness of GMP processes and the importance of equipment qualification status.

Problems can occur, for instance, in efforts to save money when ordering new equipment. For example, an old device soon to be replaced already has a relatively new printer available. One, therefore, omits mentioning the need for a printer for the new unit.

However, if the printer from the old device is used for tests performed on the new device, the moment the printer is disconnected from the old device and connected to the new device the qualified status of the old device is suspended. This is true even if, after performing the tests, the printer is reconnected to the old device and GMP-relevant measurements continue to be performed with the old device until the qualification of the new device is completed.

Once the device’s qualification status is suspended, any measurements made with the old device are thrown into question, simply because the printer connected to the old device was not tested again and documented. Moreover, there is the possibility that the new device changes the printer’s firmware.

Therefore, it is crucial to raise awareness of the importance of the state of qualification processes, or GMP compliance in general, among personnel and technicians. To ensure this awareness, it is best practice to inform employees of these expectations and obtain a written and signed confirmation that they have been informed to protect against noncompliance.

In conclusion, it is important not only to pay attention to risks impacting quality and safety but also to raise awareness of risks affecting the qualified status of laboratory equipment. This comes through raising awareness of the importance of good documentation and GMP-compliant management of laboratory equipment in general.

Regular training is an important element of GMP compliance, but it can be difficult for laboratories to manage regularly amid the many other tasks demanding attention. This is an area where GxP-CC can help. We provide various training courses that address key areas of the regulated pharmaceutical and medical device industries. If you are ready to ensure organization-wide consistency in your processes, contact us today.