Our Quality Testing Process
As we develop ENHALE, the first of our medicinal products, our quality testing process means that we conduct various tests and analysis to ensure that the device is of the highest quality and complies with regulatory standards.
In this post, we’re sharing some of our quality testing processes and why these are so important for medicines.
Why quality testing is important
Any product which is being developed with the intention of being sold to as a medicine must adhere to strict regulatory standards and industry guidelines, particularly if it has the goal of improving consumers’ health. We follow both the standards required by European Directives and UK Regulations as well as our own stringent internal quality criteria.
Testing of the medical device and its components and analysing the results allows us to ensure that they are safe for people to use and work correctly. Furthermore, the testing of all raw materials used in the manufacture of any medicine is critical to ensuring product safety.
Our quality testing process
The process of developing ENHALE is split into various “blocks” in order to maintain an agile development process, so we can quickly resolve issues as they arise.
At the start of each block, we plan out which tests need to be completed, which order they need to be completed in and the results we are looking for in order to be able to move forward. Testing is carried out on samples of the device, the results are analysed and any necessary adjustments are made.
Everything is documented thoroughly and once testing is complete, we review the results and any conclusions reached before starting to plan the next block of testing.
What happens after testing
Once testing has been carried out, we analyse the results in order to check that they match what was expected and if not, to understand why that is. Often, we will test various components or materials together to see which performs better with the device so we can select that component to move forward with.
Ultimately, our goal with quality testing is to ensure that our product is safe to use, complies with regulatory requirements and is designed to the highest standards possible.
Contact us today to learn more about ENHALE.