Investigational Medicinal Products (IMPs) that expire before last patient, last visit are undoubtedly a nightmare scenario for any Sponsor. In cases like these, there is a real risk that the study may need to be suspended – but if the shelf-life of the IMP is at an end, what else can you do?
The answer depends on the available stability data. Our expert team here at Eramol has developed an approach to evaluate and apply existing stability data in support of expiry extension. Failing this, we would look at feasible ways of generating primary stability data in time for an extension, if possible.
Once we have established that there is stability data to justify expiry extension, or generated it where necessary, we can help with planning and execution to not only compliantly extend the expiry date and shelf-life of the IMPs on your behalf, but to simplify the logistics so that trials using extended-expiry IMPs can continue seamlessly.
How, then, do we do this – and what is the distinctive value that our approach adds?
Providing data to extend dates
The availability of IMP stability data is critical to enabling the Sponsor to justify expiry date extension from the regulator, because the regulator needs to be sure that a product with an extended shelf-life is still fit for purpose throughout that extension.
But this data – which is distinct from, and additional to, the data supplied to secure the initial trial permission - can be difficult for the Sponsor to obtain and coordinate, and delays at this stage can have a knock-on negative impact on recruitment of patients for the trial.
It is here that Eramol’s approach to data delivers real, differentiated value – and here are just a few examples of it.
Firstly, we have tried and tested strategies that enable us to evaluate existing stability data and determine whether there is adequate justification for an expiry extension. This can be data derived from existing stability studies or additional product testing.
Secondly, once the stability data provided has been approved by the regulator, and the process of date- and shelf-life extension then becomes a physical, logistical, and procedural one, Eramol can also manage much of this for the trial Sponsors.
Handling the relabelling and logistics
Physically, at this point the work revolves largely around relabelling the packaging in which the IMP is supplied for trial, as this is essential to display the new expiry date and accompanying information required for compliance.
The number one challenge in this case is to provide all trial sites with IMPs that have the extended expiry date, as maintaining continuity of supply to patients and participants in the study is high-priority.
To this end, we would conduct a comprehensive assessment of stock inventory throughout the supply chain from Eramol’s depot to the individual trial sites. From this assessment we would draw up a plan of relabelling based on the individual cases.
In some cases, we would supply the trial sites with instruction and materials to relabel. This will ensure immediate available stock for use at trial site. By supplying the same materials and instruction to all trial sites, we can ensure consistency of the relabelling process carried out by the individual trial site.
In parallel, we carry out relabelling of stock held at our depot under GMP requirements, and perform Qualified Person (QP) release on the relabelled product.
Prevention is better than cure …
Although Eramol is strongly placed to support the expiry extension exercise, it is best to build in a safety margin to avoid such situations.
This is also where Eramol can add value. We can advise on planning stability studies right from the start of the study, and we can build in a stability extension plan in the initial clinical trial application.
What’s in a label? Your trial’s success…
Extending the expiry or shelf-life of a trial medication can help deliver smooth and cost-effective passage through approval and onto the market, where the product can make a huge difference to the lives of many people, sooner.
It’s just one way the team here at Eramol can help support the success of your clinical trials, whether we’re involved at the earliest stages and throughout in an end-to-end service, or in taking care of the expiry extension and relabelling only, or indeed managing any other process.
Our experience, expertise, and QPs are here for you wherever we can add value.
13.00.22 / Article
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