Allison Gilpin, business unit manager, global serialisation and Ray Hook, manager global serialisation services, PCI Pharma Services, discuss the impact of serialisation requirements on packaging operations.
Crunch time
Deadlines for including unique product identifiers on prescription drugs are putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the targets. Recognising this lack of readiness, the FDA has now extended its deadline for the US Drug Supply Chain Security Act (DSCSA) for another year to November 2018. European regulations will come in two years. Companies cannot afford to wait to adapt their supply chains to ease the complicated and challenging transition to serialisation. There is value in seeking support from suppliers which have taken a long-term, strategic approach to DSCSA requirements.
PCI Pharma Services has been serialising commercial products for five years for US, European and emerging markets. Introducing serialisation across a large packaging operation has been challenging, but ultimately beneficial. In this Q&A, Gilpin and Hook discuss the transition process, what they have learned and how companies can adopt multifaceted ways to combat counterfeiting.
When did you get started and how has the transition gone?
Hook: In the transition from our home-grown serialisation technologies to a scalable enterprise level vendor solution, our first Antares-based serialisation line went live in 2014.
Gilpin: It was a very big learning curve. An incredible amount of information, knowledge and experience is required.
Can you give a sense of the scale of the serialisation transition?
Hook: Effectively most items that become serialised will go through an entire launch process. The customer must make their artwork serialisation ready. They need to manage the inventory so non-serialised product goes out first. We then have to go through a significant batch record and process change to move from non-serialised to serialised.
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, and so on. Effectively where we had been making 100,000 units of the same thing in a batch, now we are making and tracking 100,000 unique items in that batch. Serialisation is a major paradigm shift for the industry.
How prepared is the industry?
Hook: A large proportion of the industry is not ready but has started to realise ‘we’ve got to get going’! Lots of people are starting to place orders for equipment. Their challenge will be that it is a 12-month cycle from starting to evaluate a solution to putting the first live line.
Manufacturers of serialisation equipment are seeing an increase in delivery lead times due to rising demand, even though they’ve scaled up their build capabilities. This is going to put late adopters in a tough position.
Gilpin: The staffing side is also a complex challenge. It requires a lot of external and internal resources to get everything in place to meet serialisation requirements. 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.
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How do the incoming US requirements differ from those in the EU?
Hook: The US uses a track-and-trace system — products are verified at each step in the supply chain. This addresses counterfeiting and helps the FDA eliminate bad actors from the supply chain.
Gilpin: In Europe, the Falsified Medicines Directive (FMD) process is very different. The manufacturer tells a European government the serial numbers they’re entering. They don’t tell a distribution centre 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 serialised packaging. These technologies, which destroy packs opened illegally, a substitute for the step-by-step verification of the US approach.
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 to 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: Serialisation alone cannot stop counterfeiting. A multifaceted approach is required. Layered technologies and a rotational approach to their strategy, paired with effective serialisation, significantly increases their chances to mitigate counterfeiting and diversion activity.