Our customer is the UK’s largest supplier of non-prescription medicines. The company supplies well-known pharmaceutical brands to the general public across the UK.
The Customer’s Requirements
The customer was looking for a provider of annual stability storage analysis and testing across their product range to comply with regulatory requirements. They required a laboratory capable of storing and testing 20 studies per year.
Our expertise and relationship with the customer have developed over the 10+ years we have worked with them. The length of the relationship and continued Quality Control (QC) release testing we perform has led to us becoming experts in their product range, testing requirements, and product trends.
Annual stability is a requirement that all companies must complete. Over the years Broughton has continued to demonstrate the capability to provide compliant ICH storage and GMP testing for our clients. This involves samples being removed from their storage cabinet, tested, and results reported to the customer within 15 working days.
Since 2016 over 160 stability studies have been managed by Broughton for this customer. Our services to the client include protocol review and approval, study loading into our Laboratory Information Management System (LIMS) LabHQ to allow trending to be performed by the client, analytical testing including Assay, Related Substances, and other stability-indicating parameters. We also provide results interpretation including the review of trends to identify potential issues that may occur at future time points.
How Broughton Adds Value
- In-house Stability Study Management. We provide storage and the required testing.
- We have a dedicated team allocated to stability analysis, therefore no QC turnarounds are impacted by sharing resources.
- Over fifteen years of knowledge and experience testing products, which has made us experts and less reliant on client instruction when faced with an issue to resolve.
- We provide a dedicated point of contact in order to deliver excellent customer service.
Learn More About Our Stability Storage and Analysis Services
Stability Storage and Analysis Services
Whatever stage of your product development journey, stability studies are a crucial element in determining shelf-life, active ingredient efficacy, and the long-term safety and stability of your product.