As the pharmaceutical industry continues its combat against counterfeit pharmaceuticals, some firms have been identified as delaying the initiation of their serialisation projects including the likes of CMOs and SMEs in the industry. Pharma IQ speaks to Sébastien Sliski from Zetes on the implications Contract Manufacturer Organisations (CMOs) and Small to Medium Pharma/Biotech firms can expect from projects regarding serialisation of pharmaceutical packaging. Although deadlines are looming, he advocates that there is still time for CMO’s and SME’s to build a comprehensive and agile serialisation infrastructure.

Looking beyond print and apply, what would you say are the top implications for today’s CMOs regarding serialisation of pharmaceutical packaging?

Sebastien: With the level of outsourced pharmaceutical production exceeding forty percent by several estimates, CMOs are a strategic part of the global supply process. Yet in many cases, their approach to serialisation of pharmaceutical packaging has often been postponed to the last minute or approached in a piecemeal manner.

“It is important that CMOs have the capability to meet international requirements, but must also be flexible enough to meet all of the differing requirements of their customers. Unlike a small, medium sized company, a CMO often needs the ability to be compliant with the different requirements from their external stakeholders and those of different countries. The implications are significantly more complex than just making modifications to their labelling machines and infrastructure.

“One of the major challenges with serialisation is the fact that we are mixing three data worlds. Master data, transactional data - that is following a serialised item (item, bundle, carton, pallet) throughout the packaging execution process - and the physical product. Compliance demands that all these elements are continuously and dynamically associated. This inter-linking of course demands several different competences.

These competences include physically marking the serialised code on the product – this may entail diversity of coding, serialisation formats, packaging hierarchies etc. – and needs to be linked for traceability as well as compliance. On top of this there are the aggregation steps - creating and maintaining parent-child relationships may be a legal requirement under a regulation or may become a standard requirement to help facilitate operational efficiency as serialisation regulations are implemented. This then necessitates that the correct linkages are made between each step in order to retain visibility of physical events, the transactional steps and the respective master data.

With this in mind what are the most important steps CMOs should take to overcome these challenges with the implementation of pharmaceutical packaging serialisation?

Sebastien: With all these different inter-connected layers that need to be taken into account, one of the vital steps to be made is ensuring everything is seamlessly connected to the hardware and that you have complete capability to manage serialised data e.g. provisioning, exchanging, receiving, sending, storing.

However, what’s critical is that this needs to be achieved without diminishing the overall equipment efficiency. If the throughput of the packaging line is reduced, the resulting negative impact on productivity and output capacity can be significant. So it is very important to have optimised integration between the various components on the line. This includes the marking devices, checking devices, validating devices, weight checking devices. All this checking and verification has to happen in a very short period of time and then linked to all the transactional data as well as the master data before being transmitted to the national repository. So it is a big challenge to bring all these things together at the right time and in an efficient, synchronised way.

Considering that some SMEs have not embarked on their serialisation projects as of yet and as a result may be relying on successful first time execution, what are the main dos and don’ts you would suggest for their approach to serialisation of pharmaceutical packaging?

Sebastien: Compliance is the immediate goal but following this it’s essential to also define broader business objectives and have a plan for the next steps which can extend value. This is why a lot of companies are now looking closely at aggregation: parent-child aggregation, box aggregation etc. to facilitate the next steps and to speed up the supply chain.

Remember, once you achieve visibility on the orders and the inventory you can automatically achieve an upgraded level of efficiency..

So, don’t forget to start with the wider perspective of how you can extend the value of compliance, but then refine your plan into a phased, modular approach, putting steps together in accordance with the regulatory timescales. This way you will have a mapped out your approach to ensure you meet the minimum standards but then also be able to take advantage of enhanced efficiencies that you were previously unable to achieve.

With regards to vendor selection what are the main categories and benchmarks SMEs and CMOs should have on their checklists?

Sebastien: Simplify the multi-vendor mix. With serialisation, you need to bring in a lot of different competencies, components and functions, like I said before, in a very short space of time. It’s vital to refine the mix and identify the vendors which are capable of delivering overall equipment efficiency as well as compliance. Also, they should provide be able to demonstrate the capability to integrate your serialisation solution within your existing IT and packaging infrastructure. Maintaining speed on the packaging line should be a major consideration.

Often a major clash of interests you can find within pharmaceutical packaging serialisation projects is between the software and hardware elements. For example, you will see machine vendors providing equipment and devices with, as you would expect, strong knowledge regarding technology but with very little expertise regarding the software. Conversely, the reverse applies equally to software vendors. So it’s important to look for vendors that can bring together the necessary skills and capabilities with broad expertise that reduces project complexity, risk and delivery timeframes.

Any red flags to keep an eye out for in vendor selection?

Sebastian: What is very important in you evaluation of potential providers is their continuity – you need their ability and commitment to support you through ongoing regulatory changes and new requirements. They must enable you to stay agile so that you can take advantage of new processes and technologies without having to re-implement a whole new project. Another factor you should consider is how easily interchangeable your vendors are. For example, how easy it to remove an underperforming vendor without dramatic upheaval and disruption to your operation.

A sustainable, long term relationship is very important because in today’s market, I am seeing a lot of opportunistic partnerships and new actors appearing who may disappear in the future once projects and deadlines are met. Other than the due diligence of checking their financial stability, you must ensure that track and trace will remain a core business focus and competence not just now but in the future.

How should SMEs and CMOs arrange their strategies to mitigate risk in their projects?

Sebastien: As I just mentioned, it is important that businesses have transparent relationships with scalable, agile solutions that are not embedded so that customers don’t encounter issues in four, five years’ time because technology has progressed and left them behind. Do the appropriate due diligence on the providers’ stability and continued focus on track and trace as a core competence.

Meeting the deadlines are of course vital, however how can SMEs and CMOs tangibly look to make their serialisation implementation methods as future proof as possible?

Sebastien: Legislation is likely to progress in the coming years. We see it in other markets that have gone under serialisation which are now moving on with track and trace. So, for example, it means aggregation/disaggregation will be a standard requirement in all stages of the supply chain.

There are a lot of business benefits from aggregation/disaggregation. It provides enhanced supply chain visibility and competitive advantage in the supply chain - the capacity of knowing stock location and gaining more efficiency.

Behind this legislation there are also advantages to reach for in terms of both efficiency and quality. For example, through defining each serialised item, recalls are simplified. It is a question of having the vision on how you distribute products and how you can then strategically place your stakeholders inside a global network and tackle the various silos that exist in your supply chain.