Broughton highlights the top three tips in choosing a stability partner and explains how its extensive expertise positions it as a leader in stability testing.
Broughton
Selecting the right stability partner is crucial for accelerating your product’s journey to market while ensuring its safety and compliance. A partner with expertise in evolving regulatory requirements, a tailored approach to study design, and robust analytical methodologies can make all the difference in achieving product success.
Understanding stability testing
A stability study monitors the quality of consumer products over time to ensure safety during routine production. These studies assess product behaviour and potential degradation through tests such as controlled storage, accelerated ageing, photostability, and temperature cycling.
They ensure products comply with regulatory standards set by organisations like the International Council for the Harmonization of Technical Requirements for Pharmaceuticals in Human Use (ICH) and adopted by agencies such as the Food and Drug Administration (FDA) and Medicines and Healthcare Products Regulatory Association (MHRA).
Expertise in regulatory compliance
To streamline route-to-market, consumer businesses are advised to adopt stability studies earlier into their development process. As regulatory guidelines are continuously evolving, having industry experts conducting these assessments is important to prevent overlooked issues that could lead to costly delays in gaining certified approval.
With experience in similar studies, Broughton have a broad understanding of various product types and their potential stress points, allowing them to suggest effective methods for proactive and efficient monitoring. Experts with a thorough understanding of guidelines can design reliable studies that meet scientific standards, ensuring regulatory success and patient safety.
Broughton specialise in stability studies for pharmaceuticals, nicotine, cannabis, and CBD. We have scientific subject experts available, such as analytical chemists and toxicologists, who can help provide a complete analysis of test data, understand deviations, and troubleshoot problems.
Broughton also offer expertise in extractables and leachables (E&L), allowing E&L studies to run alongside stability studies, streamlining the path to market. Our in-house regulatory team can help prepare everything needed for submission to the regulatory body.
Customisable study design
A one-size-fits-all approach is not effective when it comes to stability testing. Stability study design must be customised on a case-by-case basis to address specific product requirements. For instance, a pharmaceutical product may have multiple strengths, formulations, packaging types, storage orientations, and container closure systems, each needing a tailored approach.
Many aspects of a stability study must be specifically tailored to your product, such as the surface area contact ratio between the drug product and its container closure system. In-use stability tests also evaluate product quality after the packaging has been opened.
It is a regulatory requirement that these studies are performed on multiple batches of the manufactured product to assess the potential batch-to-batch variability of the product's shelf life. This ensures that the findings reflect what would happen in real-world scenarios, ultimately helping to maintain its safety over time.
Customised studies help identify potential degradation pathways and mitigate risks to patient safety. This approach allows manufacturers to implement necessary adjustments before market release and support product improvements.
Broughton’s range of scientific subject matter experts ensure you have complete analysis of the tailored test data. Our stability experts can collaborate with your in-house scientists or work independently to develop proactive testing strategies, with a commitment to building a long-term partnership that supports your business success.
Robust analytical methodology
Robust and accurate methodology from early phase development builds quality into the product but allows for consistency over batches, strengths and other variable aspects.
At Broughton, we use precise analytical methodologies that enable manufacturers to make timely adjustments during the product lifecycle, whether for formulations, packaging, or storage conditions. This accuracy reduces the need for repeated testing, saving both time and resources while ensuring the product’s long-term stability.
Our advanced capabilities include GMP Stability Storage solutions to ensure all aspects of your product's stability are maintained in compliance with Good Manufacturing Practice (GMP) guidelines. Broughton also offers real-time access to stability data and trends via a secure management system. All test data is recorded and validated to meet FDA 21 CFR part 11 and MHRA Annex 11 requirements for electronic records and signatures.
Broughton can assist you in various areas, including stability storage with same-day shipping when needed, new drug development services, and annual stability studies.