THE ZEFSCI BLOG
LCMS Qualification FAQ: Does Your Equipment Need Qualification?
LCMS qualification can be vital to any GxP lab that needs to maintain strict records and quality standards. In this blog we’ll cover some of the basics on qualification, including what they are and why some labs need regular qualifications in addition to regular preventive maintenance and calibrations.
Whether your lab is just starting out or is well established but moving into a more regulated space, you should be familiar with qualification processes and their benefits.
The topic of LCMS qualification can be complex and multifaceted. To clear up potential confusion, we put together a list of basic questions and answers.
Check them out below or click ahead to a specific question.
- What are LCMS qualification processes?
- How is a qualification different from a calibration?
- How do I know when to get my LCMS equipment qualified?
- What if my SOPs don’t contain qualification information?
- What if regulators don’t require qualification for my specific equipment?
- Do qualification processes require a professional LCMS service engineer?
- How often should I get my instruments qualified?
What are LCMS qualification processes?
Qualifications are the processes used to make sure LCMS equipment meets manufacturer-defined performance thresholds.
Qualification can be a critical aspect of LCMS asset management. It assures that the overall system is functioning correctly, while providing audit trails that accurately capture information and ensure compliance with an expected standard.
Unfortunately for those new to the subject, ‘qualification’ is a broad term, and there are variations in naming terminology and processes across the LCMS industry.
For the sake of this article (and our own internal naming conventions), we will cover the two main types of qualification – Installation Qualification (IQ) and Operational Qualification (OQ).
- Installation Qualification (IQ) – This qualification is performed to ensure that the installation of either a new or relocated LCMS instrument was performed according to the manufacturer’s instructions.
- Operational Qualification (OQ) – This qualification is performed to ensure that the LCMS system’s components are operating according to manufacturer defined levels of performance.
How is a qualification different from a calibration?
The easiest way to grasp the difference between a qualification and a calibration is by relating it to car repairs and maintenance. You take your car in for regular maintenance like oil and filter changes. That’s analogous to a calibration.
Any time an LCMS instrument gets routine preventative maintenance it will be shut down, maintained, and then once it’s back online, it will run a process to make sure everything is running normally. That’s a calibration.
A qualification is a lot like a state inspection and emissions test for your car. It is a series of tests and procedures performed and recorded with detailed reports to make sure your equipment meets certain standards.
How do I know when I need to get my LCMS equipment qualified?
Knowing if you need your LCMS equipment qualified all depends on the context of your work and your lab.
If you have this question, first look at your laboratory’s standard operating procedures (SOPs). If you see that your lab requires qualifications, then you have your answer.
Some labs, especially if they are smaller, may not have anything listed in their SOPs. As they grow, more documentation and procedural needs get added.
What if my SOPs don’t contain qualification information?
If you don’t see anything in your lab’s SOPs, you should ask yourself if there is any work that your lab is doing that would require qualification. If so, you’ll want to add qualification to the SOPs and get your equipment scheduled.
What if regulators don’t require qualification for my specific equipment?
While research instruments are rarely required to be qualified, you should still consider whether you need to make qualification a regular procedure. Any instruments running routine testing or in clinical labs should operate under GxP guidelines and should be qualified. Furthermore, your lab should know when to switch from R&D to a qualified platform in your development process if required.
Do qualification processes require a professional LCMS service engineer?
The short answer is yes.
Qualifications are intricate processes that require a deep knowledge of the LCMS equipment and diligent record-keeping.
How often should I get my LCMS instruments qualified?
If your laboratory SOP or external regulations require qualification for your LCMS instruments, then they should be operationally qualified once a year, and IQ’d with any installation or equipment move.
Qualified instruments should be receiving yearly routine preventive maintenance to keep it in good working order. Any work performed on a qualified system means that some or all parts of a qualification must be repeated after the repair or maintenance is complete.
Conclusion – Work with A Trusted LCMS Partner
Whether you’re in pharma, biotech or biopharma doing discovery, production, or research, working with a multivendor service partner for qualification can help. Under a multivendor contract, you can get all your equipment qualified in one visit, no matter the OEM.
An experienced multivendor provider can send expert engineers to your lab to verify your LCMS equipment performance. Some can even modify standards based on the parameters you need your LCMS instruments to meet. Note that modified qualification parameters should never be more stringent than the manufacturer’s specifications.
Need to start qualifying your instruments? Get in touch with ZefSci today to see how we can help your lab ensure operational standards.