Choosing the Right Quality Control Panel for Reliable Lateral Flow Test Production

Key Considerations for Quality Control Panels
What Is A QC Panel?
Choosing The Right QC Panel At The Right Time
QC Panel Considerations That Shouldn’t Be Overlooked
QC: Key Element When Releasing Products On To The Market
Key Take-Away

Right throughout the manufacture of lateral flow tests, Quality Control (QC) plays a vital role. From incoming QC for components through in-process QC checks to the final release of the finished product. One critical aspect of the QC process is the selection of a robust QC Panel. In this article, Abingdon Health’s Quality Control Manager, Nicole Turner explains what QC Panels are and why they are important for the successful manufacture of lateral flow tests (LFT).

Key Considerations for Quality Control Panels

It seems obvious but Quality Control needs to be focused on meeting what is needed for optimum product performance and end-user experience. QC Panel selection and performance specifications are vital – developing appropriate, robust, and reproducible incoming, in process and final release QC specifications is critical. This also means ensuring that a QC Panel is reflective of required performance, is reproducible and stable over time.

What is A QC Panel?

A QC Panel is a set of standards of known performance that are used to test lateral flow devices (LFDs) at various stages throughout manufacturing to ensure the assay is performing as required. QC samples should be well characterised and consistently reproducible to guarantee that the testing event results are valid, and an unexpected result is identified.

Choosing The Right QC Panel At The Right Time

A QC Panel should be defined in the early design and development phase of the lateral flow assay development project. Once produced the QC samples can be used to define and accelerate the development phase of your assay. Optimisation of your QC Panel post-production should not be required if design inputs, and early phase development was completed successfully. However, QC Panels can change or evolve. For example, more favourable purchase costs may be identified that support customer budgets, there may be a more reliable supply route etc. Also, during continuous improvement activities, better quality materials or the development of a new QC Panel may be better suited to support a better representation of an optimum end-user experience.

The key element, however, when developing a QC Panel, is to consider how the samples will prove that your manufactured batches work: the products need to meet performance claims. Therefore, QC specialists work with clients and assay development teams to ensure the QC Panels will test products as close to market conditions and end-user expectations.

QC Panel Considerations That Shouldn’t Be Overlooked

• Sample Matrix:

  The sample matrix selection should provide confidence the assay will work with the end-user sample. But also provide reproducible performance so that testing issues can be swiftly located to a lateral flow strip issue and not a QC sample issue.

• Concentration selection:

  QC samples should be produced at a range of characterized concentrations that directly correlate to the intended use of the LFD.

• Supply Chain and Quantities:

  Having a reliable supply chain for QC Panels is critical. Reliable supply, backed up by contingency planning, is important to guarantee that forecasted batch productions can be satisfied On-Time and In-Full (OTIF). Ideally QC Panels should be manufactured at bulk scale to provide numerous batch production testing volumes. This helps to provide batch to batch performance consistency.

• Shelf life:

  The shelf life of your QC samples needs to be determined and defined through stability testing.

• Gold standard:

  Consideration should be given to the gold standard test that will be used to characterise the QC samples and the relationship to the LFD intended use.

QC: Key Element When Releasing Products On To The Market

As a manufacturer of lateral flow medical devices, the whole Quality Management System is a critical to our contract services. Products need to be manufactured in line with fixed performance and end-user criteria. Robust measures need to be in place to make sure the criteria are met, time after time.

QC is carried out by all operational team members. Right from when materials land on site to releasing products on to the market. At no point is quality left to chance. Even though quality is second nature across departments, QC specialists are critical for the output of reliable products. They check the checkers and cast an objective eye on processes and procedures. This specialism allows for ‘getting it right first time’.

Key Take-Away

The technology and process of manufacturing a lateral flow test suitable for reliable and routine manufacture is complex. Quality Control is a fine art and QC teams need to have a keen eye for details, right from when raw materials arrive in stock to releasing final products. QC can never be underestimated, and it is important that processes and procedures are undertaken in controlled conditions to ensure products are fit for purpose. When choosing the right lateral flow contract manufacturer for your test, you should always ask about Quality Control and discuss critical aspects such as QC Panel selection at an early stage.

Quality is at the heart of Abingdon Health. We are certified to ISO 9001 and ISO 13485 and compliant to FDA 21 CFR 820 and GMP. If you require assistance to take your test from development into manufacture or you’re seeking a new manufacturing partner, contact our team.