“There’s no time to waste” was the key message from the CMO seminar on serialization in London on Wednesday 30 March as more than 70 delegates from the pharmaceutical industry joined top-level discussions on serialization, with just 3 years until the EU Falsified Medicines Directive (FMD) comes into force.
The seminar, jointly organized by Optel Vision, TraceLink and Be4ward, aimed to equip CMOs with first-hand knowledge of proactive serialization strategies that can be applied to their own track and trace programmes.
In his session covering onboarding a CMO network, TraceLink director CDMO/3PL business Graham Clark highlighted that Europe should look to what is happening in the US right now as a warning of what could happen here if CMOs do not start implementing a serialization strategy now.
“My biggest message to Europe is this: the US is not going to be ready for the November 2017 deadline because a significant proportion of manufacturers did not plan ahead sufficiently. As a result, they are trying to implement solutions at the last minute, which is putting further strain on already overstretched resources. Europe can take advantage of the time still left to get ready for the FMD – but you will need all the time you have,” Mr Clark said.
Research conducted by TraceLink pinpointed the average time to integrate serialization into a production line is 13 months, but even then, it is typically a further nine months before full production is achieved because requirements for each pharmaceutical company or customer will be different.
“The CMO business model does not typically support investment ahead of the curve, which could leave organizations in a difficult position as the deadline looms: it takes time to find the right partners, implement a strategy and then troubleshoot teething problems. But If you do not implement serialization then you won’t shift product – it’s as simple as that,” Mr Clark said.
Optel Vision track and trace solution manager Michel Bullen supported the push for CMOs to be more proactive: “CMOs need to throw the ball first, this means advising customers on how and what the best serialization solution for them would be,” he said.
Mr Bullen also made the case for implementing a strategy that takes into account aggregation alongside serialization. Comparative research conducted by Optel Vision has highlighted that implementing both capabilities at the same time could save CMOs money and time in the long run.
“Although not mandatory, aggregation is actually implicit in the EU FMD for any manufacturer exporting outside the EU. In this case you will need to open every single case and scan out, or decommission, every single item. So if we’re talking about 48 items per box, 100 items per case, and you have to scan out every single one then close it again and put it back on the pallet — you would only do that action once,” Mr Bullen said. “This is why it would be preferable to scan out just the pallet to retrieve the data for each individual item in the pallet. That’s why implicitly you’ll need to have aggregation.”
In his session about developing a serialization strategy, Vice President of Be4ward Stephen McIndoe highlighted serialization is about more than just technology, and involves complete change management. “It’s about all parts of an organization coming together, as serialization will affect everyone who handles the product in the supply chain, and if you don’t serialize or get your serialization right then you can’t sell your products.”
Mr McIndoe also identified the top ten 10 tips for developing a serialization strategy:
- Identify and interpret the emerging and evolving legislation: organizations need to ensure there is a clear way of communicating their considered view of the legislative requirements at any given moment. Failing to do this will result in individual functions or groups creating their own interpretation.
- Understand the full impact of the multiple pieces of legislation on the company and product supply chain: It’s important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that a comprehensive solution can be defined.
- Define solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with this evolving legislation: Defining the timing of implementation plans needs to be considered hand-in-hand with the solutions themselves. Another risk that needs to be considered is the “last minute rush” or “Y2K effect,” where everyone waits until the last minute to implement solutions only to find the supply base cannot cope with peak demand.
- Understand the immature and evolving solution supply base and select appropriate implementation partners: Supplier selection will often be the start of a very long relationship, as solutions that are initially implemented will need to be supported and adapted to new requirements with time. Understanding the supply base and choosing the most appropriate suppliers will be critical to long-term success.
- Resource implementation projects with sufficient serialisation specific knowledge to minimise the risk of wasted resources, delays and implementation failure: Organizations need to plan for these resource requirements, build sufficient capabilities internally and secure access to sufficient external resources where appropriate.
- Understand global versus local: To ensure that the capabilities required are appropriately specified and managed through their lifecycle, understanding and agreeing what is done globally, regionally or functionally and locally are key success factors in a serialization strategy.
- The need for flexibility: Companies need to develop solutions to cope with changing and emerging serialization legislation across the globe. Many companies have held back from progressing their serialization projects for fear of developing the wrong solutions or backing the wrong technologies.
- Define and agree some governing principles: Principles should provide guidance for teams on what is permissible or not and should be approved and managed via the governance team. Principles will create clearly defined “rules of the game” to all parties, providing a boundary and a decision making framework.
- Implement effective cross-functional governance: Establishing the right inclusive leadership and governance is key to the long-term success. All stakeholder groups involved in the delivery of the serialisation capability need to contribute effectively of the whole process is at risk of failure.
- Understand where to start: It’s recommended that a small focused piece of work covering the following objectives takes place: understand the issue as it relates to your business. Understand the likely impact across your organisation; identify, educate and mobilize an effective cross-functional governance team; establish an effective legislative monitoring capability; define an initial target response; define a plan of action; identify any initiatives that are currently under way and define how they should proceed, and understand the high level budgetary implications.
From here, a programme of activity can be implemented to effectively manage the legislative risk and oversee subsequent capability deployment. Presentation slides from each speaker are available here: https://www.serialisationcmo.uk/documentation/.