By Leah Tufts, Bellwyck Pharma Services
Regardless of whether you are a large or small sponsor, just-in-time labeling can often be an effective option when packaging and distributing your drug products. Like all clinical supply chain initiatives, just-in-time labeling comes with its benefits, but also has its challenges. This article will help you understand and overcome the challenges of just-in-time labeling so you can maximize its benefits.
With just-in-time (JIT) labeling, rather than labeling drug product in large batches, sponsors are able to request labeling of drug for specific countries, clinical sites, patients or any combination there within. This can happen for many reasons:
Despite its benefits, JIT labeling does come with a few obstacles that need to be considered. First, because of the shortened time frame to execute labeling, costs per labeling operation can be higher. The same GMP requirements for traceability are required even in a JIT scenario – so, while the timelines are shortened, the requirements for documentation and execution remain the same. Additionally, from the sponsor’s perspective, managing the supply chain can be more work and time intensive due to allocated supply not being forecasted, but managed in a JIT manner.
The biggest drivers in determining whether JIT labeling will be required are the quantity of the drug supply, the number of countries, sites, and patients involved, and the level of detail included in the labels selected for the study. Multi-country labels can be very expensive, and if you, as a sponsor, are not going to enroll patients in all the countries covered by those labels, single-panel JIT labels might be a good fit. Additionally, if the timelines for patient enrollment are aggressive for certain countries, single panel, JIT labeling may be an option to explore while the multi-country labels are being designed and approved.
Another determining factor for using JIT labeling could be the number of studies that are using the same drug pool. For example, if a sponsor has a drug pool of 1,000 bottles being used in 10 different studies, it may make sense to utilize JIT labeling. This allows the potentially limited drug supply to be optimally utilized in the case that enrollment timelines for one study are more aggressive than planned.
Finally, the cost of the drug itself should be considered when deciding to use JIT labeling. High manufacturing costs could cause decreased drug volume, making the product extremely valuable. JIT labeling ensures limited waste of product in these instances.
The realization that JIT labeling is needed, instead of or in addition to standard labeling initiatives, can be stressful – but it does not need to be. With the help of an experienced contracted partner and some careful planning, JIT labeling initiatives can be nearly worry-free and executed flawlessly.
When beginning your search for a contracted partner to complete JIT labeling, it is essential to review several criteria among all candidates. First: capacity. Does the candidate have the capacity to accept the JIT labeling project in addition to its existing clients and projects? If they do not, your JIT label project may be doomed before it begins. Next, the potential partner’s personnel must demonstrate knowledge and expertise in JIT labeling initiatives. Do they have regular training on JIT labeling? Are they able to answer questions about JIT labeling procedures, and can they show a successful track record of using those procedures? Then, the potential partner’s available technologies and infrastructure should be examined. Sponsors should take a close look at inventory and documentation systems, labeling and printing software, proper shipment containers, and the designated spaces for all of them in-house. Finally, you will want to review the potential partner’s spaces, technologies, and capabilities for short-term storage of the drug product. As The Challenges of Packing, Shipping, Storing, and Distributing Highly Sensitive Drugs illustrated, oftentimes expensive drugs have specific conditions for storage and transport. Failing to adhere to necessary product-specific conditions could result in product loss.
You have determined your drug product will require JIT labeling and have found the contracted partner to execute it – how do you plan the JIT labeling strategy? Just like any labeling and packaging strategy, planning early is essential, but this is especially important for a JIT labeling strategy because the timeline for execution is abbreviated. Early planning considerations for sponsors include:
Typically, sponsors will reach out to the contracted partner’s proposal department and explain what their JIT labeling needs are and why it is the appropriate initiative. Understanding the reason why will help determine the next courses of action. Is JIT labeling needed because the product will head to multiple countries? Or is it a more specific need, such as an exact number of patients receiving the drug? Finding this understanding involves conversations between the person who’s going to write the proposal, the site lead, and others with supply chain responsibilities from both parties.
The contracted partner’s project manager (PM) is at the helm of the JIT project, as this person has a full understanding of the intricacies and specifications of the sponsor. Based on conversations with the sponsor, the PM will take action, setting up work as early and up front as possible to help ensure perfect execution of the project. This includes having the label text ready, potentially having labels printed, and having batch records approved. This preparation leads to further efficiency downstream — the QA department can release the drug faster, the packaging department has the proper materials, and the logistics team has customs information and documentation for international shipments and is prepared to ship and track shipments sooner. All this up-front work should give you, as a sponsor, the confidence that your partner will execute the JIT labeling strategy in the agreed upon time frame when the trigger is pulled. In fact, the sponsor should have the confidence that a JIT labeling project will be handled just like any other labeling project, just under a condensed timeline. Further, the benchmarks of success of a JIT labeling project should be the same as a standard one: sites will receive drugs at the correct destinations, on time, so trials can advance, and drug products can become commercially available.
In most circumstances for an expedited timeline, JIT is the best and most efficient solution to ensure studies receive the drugs they require, when they are required, and without waste. When properly executed, JIT labeling optimizes the clinical packaging and labeling processes while simultaneously adding flexibility into the supply of drug product.
Leah Tufts is VP of U.S. operations at Bellwyck Pharma Services. Leah oversees the entire U.S. operation, including distribution, warehousing, and packaging activities. Her role includes managing the growth of the site, both in personnel and facility capacity and capabilities. She has been with Bellwyck for six years, previously overseeing the clinical QA team. Leah’s experience prior to Bellwyck ranges from commercial manufacturing and packaging to clinical R&D.
Bellwyck Pharma Services