A Q&A with Allison Gilpin, Business Unit Manager, Global Serialization, and Ray Hook, Manager Global Serialization Services, PCI Pharma Services
The November 2017 deadline for including unique product identifiers on prescription drugs is putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the target. Here, we look to the experience of a company that is ahead of the curve for lessons on how to manage and ease the transition to serialization.
More than three years have passed since the US federal government signed the Drug Supply Chain Security Act (DSCSA) into law. Yet, despite facing a series of upcoming deadlines, many companies have held off on adapting their supply chains to the incoming requirements. Now, with the November serialization deadline looming, companies cannot afford to wait any longer.
Companies trying to meet the deadline from a standing start today will face acute challenges. The transition to serialization of products is logistically complicated during normal times. The coming months, in which an entire industry is seeking the equipment and expertise needed to serialize products, will not be normal times. Lead times are extending and competition for resources is intensifying just as companies need to move forward at full tilt.
Faced with this situation, there is value in looking to companies that have taken a very strategic approach to DCSCA readiness and timely implementation for lessons in how to manage the implementation of serialization.
PCI Pharma Services has been serializing commercial products for five years for US, European, and emerging markets. Along the way, PCI has adopted AntaresVision as its enterprise serialization system at all its European and North American sites, and qualified Marchesini for additional equipment solutions.
Introducing serialization across one of the largest packaging operations in the industry has been a challenging, but ultimately highly beneficial experience according to Allison Gilpin and Ray Hook, PCI Pharma Services.
In this Q&A, they discuss the transition process, what they have learned along the way, and how companies that still have work to do to meet the deadline can prepare.
When did you get started with serialization and how has the transition gone?
Hook: In the transition from our home-grown serialization technologies to a scalable enterprise level vendor solution, our first Antares-based serialization line went live in 2014. It was a voyage of utter discovery. In the last three years we have gone from knowing the theory, to becoming an organization containing expert practitioners in serialization.
Gilpin: It was a very big learning curve. There’s an incredible amount of information, knowledge and experience required. We take people into our team and, to a person; they are shocked by how much is involved in serialization. No matter how experienced they are as an engineer or how experienced they are as a project manager, this is a completely different world.
Can you give a sense of the scale of the serialization transition?
Hook: Globally PCI packages over 8,000 items. Most of those items that become serialized will effectively go through an entire launch process in the transition. The customer has to make their artwork serialization ready. They have to manage the inventory so non-serialized product goes out first. We have to go through a significant batch record and process change to move from non-serialized to serialized.
Gilpin: It’s a huge amount of work and it’s not just an engineering effort. It touches many functional departments, marketing, purchasing, project management, quality, regulatory, operations, etc. We’re all engaging with serialization.
It’s a huge learning curve for packaging teams, line leads, supervisors, quality inspectors, and everyone else within the facilities. Everything they do normally needs to be re-evaluated and thought of differently. Effectively where we had been making a 100,000 units of the same thing in a batch, now we are making and tracking 100,000 unique items in that batch. Serialization is a major paradigm shift for the pharmaceutical industry.
How prepared is the industry?
Hook: A large proportion of the industry is not ready. Those people who have not started are suddenly waking up realizing, holy cow, we’ve got to get going. Lots of people are starting to place orders for equipment. Their challenge will be that from starting to evaluate a solution to putting the first line live is a 12 month cycle. There are nine months left today.
Manufacturers of serialization equipment, even though they’ve scaled up their build capabilities, are seeing an increase in lead times. We’ve seen delivery lead times increase from typically five to six months to now seven months or more for a single piece of equipment, just over the last four months. So as 2017 progresses, I can see that increasing to eight or even nine months. This is going to put late adopters in a tough position.
Gilpin: The staffing side is also a complex challenge. It’s going to require a lot of resources, whether it’s outside vendors or stepping up groups internally, to get everything in place for November. Many of our clients are relying heavily on consultant and contract resources to support their knowledge gap, but demand for those resources is also increasing exponentially.
What will be the consequences of failing to meet the deadline?
Hook: It will be illegal for non-serialized products to enter the supply chain on November 27th, 2017. Any product going into a distribution center is open for FDA or federal government sanctions which could include fines for non-compliance. The polls we’ve taken indicate at least 50% of businesses are not ready as of today.
What options are available to companies that are behind on preparations?
Hook: Customers can bring uncoded packages to PCI and we’ll run them through our Flexsuite™. The Flexsuite™ is designed to receive cartons of a wide variety of sizes, from a matchbox to a shoebox. It serializes the carton, which is then aggregated to the case and onto the pallet.
What is the purpose of aggregation?
Hook: Operationally, at the end of a packing run, a critical step is to understand where 100% of the serial numbers have gone, both viable numbers as well as those that were scrapped or not used. So conceptually if you’ve got a packaging run of say, 40,000 units, which is not atypical, then you have a responsibility to understand where every one of those 40,000 numbers has gone. If a few are missing, we would need to investigate and that happens immediately in the batch. With the advanced technologies involved, it is a very robust and controlled process to provide that assurance. Serialization gives you that control and positive verification.
By reading boxes at every stage of the packing hierarchy, we know which cases are correctly built and can discount them as being the cause of the missing numbers. This process, known as aggregation, allows us to focus on the areas of the packaging suite that may have caused the issue.
When we’re aggregating, we close a line down in five to ten minutes. Whereas not aggregating, it can take over an hour. That’s lost production time.
Gilpin: The other significant benefit from aggregation is in the broader supply chain. With aggregation you know specifically what is on each pallet, what is in each case, etc. due to the electronic verification and parent-child data pairing. This benefits the manufacturer, the wholesaler, and the downstream trading partners. Without the benefit of the electronic aggregation, the supply chain participants are left to “infer” what is contained on a pallet or a shipping case, which has been proven to be extremely problematic.
Are there any operational benefits of serialization?
Hook: Yes, there are multiple benefits. Primarily serialization provides control and positive verification. For example, when serializing if a creased label gets put onto a case so you can’t read the barcode and the case is rejected, the contents of the case become available for repacking, whereas previously anything that came off the line was rejected and repacked. The rejection and repacking process destroyed cartons and some leaflets. As such, serialization reduces waste and saves time.
Serialization also supports automation. At the front end of the line, software has replaced manual entry of lot numbers and expiry dates. This has increased quality standards while cutting resource use. Similar benefits are realized by deploying cameras at the back end. There’s no need to weigh a case to check it contains 24 packs. The camera keeps count and the system labels accordingly.
How are post-packaging modifications for sampling, damage, and rework handled?
Hook: Our Antares platform supports post-production interference with serialized material after packaging for situations like sampling, damage, or rework. If a customer asks for 10 additional samples after a batch has been completed and closed, we can go back and open a pallet, take 10 units out of a case, reseal the case with a new partial case label, and reseal the pallet with a new quantity using the Antares system while amending the aggregation data set. This can all be done in the warehouse rather than needing to create some special operation.
The same system handles damaged products and ensures pallet-level and aggregation hierarchy data we send to customers is accurate, not a theoretical figure based on production output.
What effect has serialization had on overall equipment effectiveness and productivity?
Hook: There is a lot of evidence that early implementation of serialization had a negative 20% or 30% impact on productivity. We can agree with that from our earliest lines. But now, with the experience we have, we’re really not seeing a great downturn in the productivity of a line. In some instances we are seeing the new equipment and processes are improving control and efficiency.
How do the incoming US requirements differ from those adopted in the European Union?
Hook: The US uses a true track-and-trace system. Products are verified at each step in the supply chain. This will enable the US to address counterfeiting and help FDA eliminate bad actors from the supply chain.
Gilpin: In Europe with the Falsified Medicines Directive (FMD), the process is very different. The manufacturer tells a European government the serial numbers they’re entering. They don’t tell a distribution center at all. The next normal verification step is when a pharmacist is about to hand a pack to a patient. Other than some special auditing, which is relatively low level; there are no checks throughout the supply chain in Europe.
Instead, Europe is mandating the use of tamper-evident technology on serialized packaging. These technologies, which destroy packs that are opened illegally, substitute for the step-by-step verification of the US approach.
Most people either love the US model and dislike the European model, or vice-versa. Yet both are valid ways of managing supply chains.
What other approaches are companies using to prevent counterfeiting?
Hook: Layering of anti-counterfeiting technology is popular, particularly in Europe. Companies are adding features such as photo-reactive elements to packaging so they can verify its authenticity by exposing it to light of a particular wavelength. People may also add microcode or intentional design defects that a counterfeiter may overlook when copying product packaging and leaflets.
Gilpin: This is necessary because serialization alone cannot stop counterfeiting. A multifaceted approach is required. Layered technologies and a rotational approach to their strategy, paired with effective serialization, significantly increases their chances to mitigate counterfeiting and diversion activity.