Beyond Item-level Serialisation: Extending Traceability...

102 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2014 Volume 6 Issue 4

Packaging

Beyond Item-level Serialisation:

Extending Traceability Schemes to

Secondary and Tertiary PackagingThe Case for Aggregation; The Legislative AgendaFalsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favourite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.

Over the next few years, major markets and trading blocs, including the EU, the USA and Latin America, will enact legislation mandating that each patient pack will have its own unique identification number. Add to this schemes that are already either in force or being implemented in China, India, South Korea and Turkey and it is clear that there is significant momentum towards establishing item-level serialisation as the global standard

for proving the origin and source of each and every pharmaceutical pack. Against this backdrop, counterfeiters across the world will find it much harder to infiltrate legitimate markets. Even if the packaging and branding look authentic, item-level serialisation will help prove an item’s authenticity.

But moving unique products around the world presents its own problems. Items don’t move as single units, but in batches on pallets or in cases. Keeping track of what is included inside the secondary and tertiary level of packaging is the next major challenge for the pharmaceutical industry. Aggregation is about understanding how to accurately record serialised pack data and build that into a hierarchical structure that records detailed information about each pack’s progress through the supply chain.

The challenges of serialisation are well-documented; however aggregation requires an altogether higher level of data processing and joined-up thinking. Inserting the correct quantity of goods into

a box and applying a label is only half the battle. This paper will demonstrate that where serialisation is required, aggregation is a logical extension – even if not mandated – and one that delivers a range of benefits.

The Data ConundrumSerialisation generates huge amounts of data, creating storage and data integrity challenges. Each item consists of two parts – a physical asset and a data asset. The association must remain linked from the moment a unique identity is assigned to a pack right through to the moment it reaches a patient.

This alone requires a modal shift in the manufacturing mindset, with each pack effectively a unique batch of one. Reconciliation, which has until now been a line side task completed once per batch, will in future need to extend right through the supply chain and be open to interrogation for the life of the product and beyond.

All serialisation schemes decree that

Photo 1: While some of the schemes in play include aggregation as a requirement, others do not

Photo 2: Print and apply labelling machines, such as this Domino M-Series, are a flexible option, suitable for use at bundle, case or pallet level

- - - - - - - - -- - - - -- - - -

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Legislation milestones you should consider on serialization

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2018European unique id.[ fmd 62/2011]

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85103 40000 00018 12200

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Packaging

all product data must be uploaded to a national or supra-national database against which product IDs will be verified at the point of sale or dispensing. This in turn raises the question of data aggregation (or the establishment of hierarchical relationships at each stage of the packaging process).

While some of the schemes in play include aggregation as a requirement, others do not. However, it would seem to be a practicable extension of item-level serialisation, enabling, for example, the data for each pack in each bundle, and each case on a particular pallet, to be retrieved with a single scan.

Whatever the motivation, it is vital to start planning for aggregation early on in the manufacturing process. It is almost impossible to consider aggregation separately to serialisation. Just like building a house, it is best to start from

the foundations upwards as any attempt to retrofit aggregation after the fact is fraught with difficulties.

Pulling in the Right DirectionSuccessful aggregation strategies depend on multiple departments pulling in the right direction. It is no longer the case that products can be manufactured in a factory and simply handed over to the distribution department for despatch.

Now, the entire system of production can break down without cooperation between departments and disciplines. The fork-lift truck driver needs to be just as aware of the implications of pallet aggregation as the production manager or the IT department. Even the marketing team needs to be aware of how aggregation works, as designing the wrong GTIN identity can cause ripples throughout the entire supply chain.

The core challenge of putting a label on a box was resolved many years ago. The hidden challenge is what is going on behind the scenes to get the data to put it onto a box. How producers do all that effectively, taking account of all the stakeholders and without impacting negatively on transport or logistics, is fundamental to successful aggregation. In Domino’s experience, up to 80% of conversations in this area revolve around the practical problems of transferring serialised products from the primary packaging line to aggregated products in the secondary and tertiary stages.

The actual mechanics of label application are relatively simple. The problem-solving comes down to discussions on what sort of relationships pharmaceutical manufacturers have with their respective supply chain; recognising who is important, and finding a way to integrate aggregation within their existing set-up. Many manufacturers are comfortable with the technical and mechanical aspects of label application; it is the higher level of consultancy, solving the end user problems of serialisation or aggregation that manufacturers are looking for.

The cost of failure is high. Manufacturers can apply 20 labels a minute, but if a company has a breakdown which means that it has to manually search and de-aggregate 20 pallets, then any speed advantage is irrelevant. What is more, if a pallet or batch has

to be de-aggregated, then it generates a huge range of complications in terms of decommissioning serialised numbers. One bad case in the manufacturing process can create a whole world of problems.

There is also a blurring of the lines of demarcation between good manufacturing practice – traditionally confined to the production hall – and good distribution practice, which, if not recognised and embraced, can compromise aggregation. Drawing up a protocol that reflects the requirements of each discipline will avoid the traditional disconnect between how products are treated while still within the manufacturing arena and how they are handled once in the distribution stream.

The Benefits of AggregationProperly implemented, aggregation will save pharmaceutical companies time and money. Automated packaging lines have the ability to pack and label cartons efficiently and accurately. Combine this with a system that enables finished batches and shipments to be interrogated instantly to locate any pack, at any time, anywhere in the supply chain, and the appeal of aggregation is instant and abundant.

Supply chains can be long and complex, with security only as strong as their weakest point. From a brand protection perspective, the ability to spot-check the location of each pack with pinpoint accuracy is compelling, while those charged with delivering supply chain efficiencies will find much to interest them here too.

In terms of data management, much has been said and written about the technical and logistical challenges of recording and storing the vast volumes of data associated with item-level serialisation. Aggregation is a very tempting prospect in this regard; the possibility is that a single pallet code might be all that is required to hold the data associated with each one of the potentially thousands of packs it contains.

The correctly-assigned hierarchical relationships and robust code data encryption associated with a well-planned aggregation environment make this a very realistic scenario, effectively minimising or even eliminating the requirement for a big database.

Photo 3: The smaller the footprint of the print & apply labelling machine, the easier it is to integrate the technology into existing production lines

Photo 4: It is almost impossible to consider aggregation separately to serialisation

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Is Aggregation Mandatory?Is aggregation mandatory? The simple answer in most legislatures is ‘no’. In the EU member states for example, the Falsified Medicines Directive (FMD) does not specifically state the requirement to initiate aggregation in the pharmaceutical manufacturing process. But the pharmaceutical sector is a global industry, so what is not mandatory in one region, may well be in other markets. It doesn’t matter where a product is manufactured, but where it is sold. In many cases, pharmaceutical companies have no idea of the final destination point of their products at the point of manufacture.

The EU is introducing the Falsified Medicines Directive, Brazil operates under ANVISA, Argentina with ANMAT, the US with the senate bill (Drug Quality and Security Act), South Korea with MHW, and China with the CFDA. Any country might integrate a mandate for aggregation as part of its crackdown on counterfeit goods.

Taking the EU FMD as a particular reference point, its rules apply to all branches of the pharmaceutical industry including research-based manufacturers, generics producers, contract packers, parallel traders’ importers, wholesalers and distributors. Any organisation intending to supply into the EU either prescription-only medicines (POM) or over-the-counter (OTC) products, included in the scope by risk assessment, will not be able to do so unless it is fully serialisation compliant.

But aggregation comes as part of that. One cannot demonstrate the complete traceability that many are hoping item-level serialisation will bring without knowing where a unit pack is as part of a consignment. It must be traceable through the distribution network; whether as a serialised pack or aggregated pallet. Many consignments are also destined for multiple destinations. A shipment of 100,000 cartons may be destined for two or three overseas markets. Not knowing which pack is contained in which box, the distributor has no way of complying with serialisation. Part shipments can either be physically separated on the pallet by hand, or a much more efficient method is to control the data via aggregation, enabling producers to be able to identify and report on exactly what is contained inside each pallet or shipment.

The legislative framework for introducing serialisation into the EU FMD starts in 2018. That is enough time to put the issue on a back burner. But if pharmaceutical producers focus all their efforts on serialisation, and not on aggregation, then it will be virtually impossible to bolt on a solution later. So many variables are involved in a serialisation operation that, even if manufacturers lay out a perfect strategy, they will miss some areas. If not factored in at the outset, aggregation is unlikely to succeed.

By default, therefore, aggregation is mandatory, not through any written part of a directive, but through the practicalities of the distribution network. If goods need to be shipped around the world, the end user, the customs officials and the importer are all going to want to know which goods are contained in each shipment.

The Cost of Getting it WrongIf manufacturers label a pack incorrectly, it will cost them a few pence. If they label a case incorrectly it might cost them a few thousand pounds. But if a pallet leaves the factory with the incorrect information, the cost can run into millions of pounds of lost revenue.

Decommissioning serialisation numbers in manufacturing areas is complex enough; doing so in a distribution environment is fraught with problems. What distributors are trying to do is manipulate a data asset that originated elsewhere, in another environment, which is extremely difficult to do.

Any rejects need to be verified and double-checked with the manufacturer before they are decommissioned from the serialisation chain. This involves checking to see if the pack belongs to the manufacturer, if they have been incorrectly packaged, damaged, mis-read, or if they are counterfeit.

Once a tamper-evident seal is broken on a pallet, security is compromised and the batch has to be re-manufactured rather than re-packaged. Reconciling the non-reads leads to a whole raft of inefficiencies and problems. In the pharmaceutical industry, manual hand-packing is the norm for almost 80% of all palletisation processes. That creates an enormous risk, as human error is always

a factor in labour-intensive processes, but automating the aggregation process eliminates a huge element of risk.

Speed is critical in a manufacturing environment - time is money as they say. But the flip side is the cost of getting the manufacturing process wrong. Most manufacturing facilities measure their efficiency with an overall equipment effectiveness (OEE) rating. It not only measures the speed of the manufacturing line, but the equipment up-time, the percentage of good units over bad and any maintenance needed.

The prevailing wisdom is that serialisation will adversely impact the OEE for most drug production lines by around 10-20%. That is going to cost millions of pounds in production time for the average drug producer. Any percentage improvement on the OEE rating is a massive gain, with the potential to recoup any investment in automated aggregation lines in a very short space of time.

But some OEE issues are going to be completely new to the manufacturing sector. What happens, for instance, when there is a data loss and the serialisation code does not match the pallet or the batch? The only solution is to conduct a manual check on the pallet contents, considerably impacting on the OEE performance of the manufacturing or distribution facility.

Many pharmaceutical companies are still aggregating items on hand-packing lines or by case-level packing. If there is a problem, the label cannot simply be peeled off and replaced. The speed of labelling is not as critical an issue as it is to be accurate. If, for instance, an error occurs on every third pallet, it will lead to an immediate 30% drop in a manufacturer’s OEE rating.

If manufacturers are labelling at case level, and building a pallet manually, there are major implications for productivity and profitability levels. If just one of the cases is labelled incorrectly, the pallet production is exposed to a whole new set of complexities, potentially compromising the entire shipment.

Good Manufacturing Practice v Good Distribution PracticeThe fact that the GxP status quo needs to change to accommodate serialisation

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Packaging

and aggregation is an indicator of just how disruptive these changes are. But, drawing on the generally accepted definition of disruptive innovation as a force for good, there are potentially positive outcomes. Technology is making convergence a fact of everyday life; managed properly, it can go a long way to overcoming the inefficiencies associated with operating in silos. Looking specifically at the pharmaceutical sector, there are opportunities to transform the traditional hand-off from production to warehousing and warehousing to distribution into a seamless operation with an impeccable audit trail.

Print & Apply LabellingThe same principles apply to equipment capabilities for aggregation as they do for serialisation; printers need to have on-board capability to apply unique information to each aggregated ‘unit’. Establishing hierarchical associations between the unit-of-sale packs in a bundle, bundles in a case, cases on a pallet and so on, enables any party authorised to handle the product on its journey through the supply chain to interrogate precisely which items the batch contains in a single scan.

While speed is not such a significant requirement in code application at aggregation stage, quality and legibility most certainly are; a pallet code is effectively the key to the unique data associated with every single item on the pallet. Just as users have a choice of technologies at item level, so too are there options at secondary and tertiary level. Print & apply labelling machines are a flexible option, suitable for use at bundle, case or pallet level, while

for direct printing onto cases, large-character continuous inkjet systems offer a label-free solution.

Print & apply systems have been around for many years, but their footprint and speed continues to improve. An effective and increasingly popular method of label application in the pharmaceutical sector is the corner wrap, where a label is applied to one edge of a box, and wrapped around to stick to another side of a pack. Corner wraps are highly recommended by the Healthcare Distribution Management Association (HDMA) in the US and the distribution channel generally ends up dictating the look, feel and position of the corner labelling solution.

The smaller the footprint of the print & apply labelling machine, the easier it is to integrate the technology into existing production lines. The control and positioning of the label is critical for an efficient and reliable manufacturing process. Many pharmaceutical manufacturers may be working with two or thee partners to introduce serialisation, so it is vital to understand the mechanics of the equipment they are working with.

As pallets are normally stored in cramped and badly-lit conditions, it is also important that labels are easily legible by hand-held scanners. Corner labels are large enough and accessible enough to be read with comparative ease, providing the aggregation information needed for easy recognition and distribution. Again, any savings in time can be of enormous value to shippers and pharmaceutical companies, so providing the means to read and convey information is as important as correct labelling.

The Business Challenge – or the Business Opportunity?This paper has identified that while serialisation is in itself a challenge that is currently exercising pharmaceutical manufacturers ahead of impending legislative deadlines, it is one that is best dealt with in conjunction with aggregation. Project engineering new equipment into existing lines is the essential first step for the packaging hall. But beyond that, the critical success factor is gaining senior stakeholder engagement to establish a robust serialisation and aggregation infrastructure in the short term.

As stated before, aggregation is not just a challenge for the manufacturing hall, but needs to encompass logistics teams, warehouse managers, IT personnel, marketing teams and pack designers, to create a ‘one world’ vision.

Whilst serialisation has the potential to increase the trust in the brand and manufacturer for medicines of all description, aggregation has the ability to get them to patients in an efficient and orderly manner. There is not much time left for implementation. Although aggregation is not written into the most pressing legislative deadlines, logic dictates that it will become a requirement sooner rather than later. Implementing serialisation without at least planning for a subsequent aggregation deployment could prove to be a very costly and time-consuming strategy.

Successful implementation of automated aggregation lines can offer significant benefits. For those manufacturers who want to gain a leadership position ahead of the deadlines, now is the time to plan to go ‘beyond compliance’ well before it becomes a legal requirement to do so.

Craig Stobie has worked for Domino for over 18 years in technical, operations service and commercial roles. Craig has a broad view of the legislative and commercial pressures

facing the healthcare sectors and is well versed in current and impending global legislation.Email: [email protected]

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