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Stability Case Study - Multinational Pharmaceutical Company

Customer Profile

This project was completed for a leading multinational pharmaceutical company. The company operates globally providing the general public around the world with essential pharmaceutical products. 

The Customer’s Requirements

The customer required the transfer of a large batch of 40 stability studies that were already in progress. The customer’s in-house stability storage chambers were aged and close to failure, and the customer required an analytical partner to take on the in-progress studies. 

Why Broughton

We had initiated Analytical Method Transfers (AMTs) on multiple products for the customer. Working with a partner who could not only store samples but also test them was a key reason for the customer choosing to work with us. The relationship between Broughton and the customer was a relatively new one; however, analysis completed to date and successful audits demonstrated our capabilities in stability study management. We have been successful in delivering extra value to the customer in numerous ways: 

  • We provide in-house stability study management storage and the required testing.
  • We provided a team dedicated to stability analysis meaning no Quality Control turnarounds are impacted by sharing resources.
  • We have a highly experienced team in testing pharmaceutical products. This experience has given our team expertise in troubleshooting and problem-solving, meaning we work efficiently and are less reliant on customer instruction when faced with an issue to resolve. 
  • We provide a dedicated point of contact in order to deliver excellent customer service. 
Broughton Stability Storage and Analysis

Project Deliverables

The key deliverable for this project was the transfer of 40 stability studies from the customer's storage chambers without impacting the studies. The transfer of the studies was well managed with the samples received at our stability facility, unpacked, reconciled, and loaded into the storage chambers with minimal time spent outside of the controlled environment. All actions were clearly documented and risk assessed through a change control and record of activities provided to the customer.

Once the transfer of the studies was completed, we performed analytical testing including Assay, Related Substances, and other stability-indicating analyses for the customer. In addition, we loaded the studies into our Laboratory Information Management System (LIMS) LabHQ to allow trending to be performed and results interpreted ensuring that we were able to identify any potential issues that could occur at future time points.  

How Broughton Adds Value

Attention to detail in sample management is a key strength of the Broughton team. To ensure optimum service, all sample labeling and other project information is requested in advance, ensuring that the Broughton team is prepared and we can tailor our reconciliation documents to suit. Our protocols ensure that all stability samples are labeled with a study reference, time point, condition, and batch number to allow for an efficient process that minimizes errors and allows for an efficient process. It is such attention to detail, as well as our ability to work closely with our customers and anticipate their needs, that allows us to manage such large-scale stability transfer projects with confidence.

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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.