After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or that your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or whether your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

Electronic Product Code Information Services (EPCIS) is a global GS1 Standard for creating and sharing supply chain information, both within and across enterprises, which enables companies to gain shared, often real time visibility of their end-to-end supply chains. Anyone who has been involved with trying to make business processes and information flow across multiple organisations and IT systems will understand the value of such standards to govern data format and transfer methods. This is the reason for the existence of organisations like GS1 and why it’s member organisations pay it’s fees, and often contribute significant employee time to helping develop these standards. This is also why those same member organisations implore regulators to adopt and mandate those standards in their legislation.

 

Today, compliance to these standards brings benefits such as a reduction in the cost of maintenance or upgrade of interconnected system and increased agility to change supply chains. In future, adherence to these standards will be the key enabler that allows companies to take advantage of supply chain big data, artificial intelligence and end-to-end visibility technologies that will bring benefits simply not possible today.

 

During the global deployment of Pharma serialisation/traceability over the last 15 years, much time and effort has been put into the development of the EPCIS standards to enable the frictionless flow of supply chain visibility information, but what exactly does it mean to be ‘compliant’ with EPCIS?

Does it mean ensuring the EPCIS messages you generate and receive conform to the EPCIS Schema and Core Business Vocabulary and conform to published guidelines from GS1 Member organisations?

Or does it mean that systems just work for getting data from point A to point B and hopefully loosely follow EPCIS?

And how do we measure and monitor this compliance?

Within your own organisation, are your system suppliers claiming their compliance is sufficient? Are the various EPCIS compliance/testing services adequate?

And what importance is the industry placing on being ‘compliant’ in any form?

In response to a global manufacturer wanting to evaluate their overall EPCIS compliance, Be4ward, supported by tools from their partner Jenneson, developed a four-level methodology focusing on:

- Technical adherence to the EPCIS standards
- Measuring risk associated with the proper/improper use of EPCIS for market regulatory compliance
- Best practice EPCIS design to enable future value opportunities from serialisation/traceability data

Our in depth compliance review allows you to take control of your own EPCIS compliance.

Contact us to learn how Be4ward’s approach can help you identify and mitigate foundational EPCIS data issues.

 

Devendra Mishra Executive Director of Bio Supply Management Alliance interviews Be4ward Principal Consultant Grant Courtney on the topic of traceability capabilities within the global Covid-19 vaccine supply chains.

Q. How has the lack of visibility/ traceability in the end-to-end COVID-19 vaccine supply chain been of major detriment?  

A. I would suggest that the lack of end-to-end traceability has not been of major detriment to vaccine supply rather that many of the issues being encountered can be attributed to other factors. Very few countries in the world have currently implemented traceability systems across their end-to-end supply chain. Turkey was the first and perhaps the most comprehensive system currently in operation. The system tracks the product from the point of manufacture through to the point of dispense and is used to prevent falsified products, reimbursement fraud, product diversion and promote the safer use of drugs. To achieve this, GS1 Standards have been implemented to allow the identification of items such as a pack, case or pallet and also for locations. Traceability events are then captured as the medicines move through the supply chain. 

Visibility in the Turkish system is achieved through the use of a central traceability system which was financed by the Turkish Medicines and Medical Devices Agency (TİTCK), which is affiliated to the Turkish Ministry of Health. This project took four years to achieve, starting in 2008 and completed in 2012. So clearly the establishment of traceability systems takes many years, relies on the establishment of legislation and requires significant investment and effort across all the stakeholders required to use the system. In Turkey there are over 42,000 stakeholders connected to the system, including 408 manufacturers, 592 wholesalers and over 25,000 pharmacies. 

Another significant example of implementation of serialisation is the European Medicines Verification System (EMVS) which was set up in response to the EU Falsified Medicines Directive.  As the name suggests, this is not a track and trace type system such as the one described in Turkey. The primary purpose of the EMVS is to verify every pack prior to dispense. This system does not provide complete visibility of the supply chain as not all product movements are tracked through the system. The fact that relatively few countries currently operate full track and trace traceability systems, tells us that end-to-end traceability is not a pre-requisite for a well-run and controlled supply chain, although clearly it helps and has additional benefits. 

Many of the challenges for the distribution of a COVID-19 vaccine are going to be the same as any other product, such as the need for common identification of an item, standard barcodes, accurate product master data and supply chain partners who are able to share data and transact through common processes.  It is more likely to be issues in these areas that present challenges to the distribution and management of a COVID-19 vaccinerather than the lack of traceability per se. 

 It could be argued that it is the introduction of common standards, processes and interoperable systems that drives many of the benefits when establishing a traceability system, as these are all needed for traceability to function and are evident in highly efficient supply chains. 

 Utilising common barcodes at all levels of the packaging from the vial up to the pallet would allow items to be scanned and the data captured for Logistic and Clinical purposes. Product Master is made available to all stakeholders so that systems can be populated. Transitions based on global protocols and standards ensures there is more interoperability of processes and systems. These are all factors that enable any supply chain to operate with Global Standards very much the DNA of any highly efficient and effective supply chain.  

 

Q. How can serialisation of drugs and vaccines enable the required integrity in the manufacture and distribution of drugs? 

A. Although serialisation and traceability are not the primary factors in operating efficient supply chains, there are benefits which come with their implementation. Traceability through the vaccine supply chain using track and trace offers benefits by providing full product visibility from manufacture to patient’s arm. Knowing where inventory is at each stage of the supply chain makes for a safe and efficient supply chain. The benefits go further than just manufacture and distribution, all the way to administration of the drug and pharmacovigilance.  

By giving each product a unique identifier, we know it is a legitimate vaccine, we know the vaccine type and how many doses are contained in a vial. We also know the location of each vial at all times. This full visibility aids redistribution, recall and the integrity of supply chain before we even consider the big benefits of preventing product falsification and diversion. 

As we collect more data on these vaccinesit could be that we are able to extend shelf life. Traceability and digital data store to vial level allows us to update information held without having to recall or waste product. Similarly, there are benefits relating to electronic patient information. Much of this product is going out in common packaging across all countries, in a single language on the packaging. Barcodes can be used to scan and access leaflets in different languages.  

Due to the acceleration of manufacture with these vaccines, extra vigilance is required relating to, for example, side effects. Robust, reliable product data is essential here with product code and batch code linked to patient records for pharmacovigilance purposes.  

 

Q. In the emerging global situation of the disparity between demand and supply of COVID-19 vaccines, falsified products may appear in the marketplace. What is the solution? 

A. Unfortunately, we have already seen criminals profiting from the pandemic. Initially this was PPE items and some therapeutics, but there are now reports of criminal gangs gearing up to supply fake vaccines. In February 2021 authorities in China arrested over 80 people and 3,000 doses of fake COVID-19 vaccines were confiscated. It is understood that the group had been profiting from making and supplying the fake vaccines since September 2020 and that it is likely these were destined for export to countries in Africa. We have the conditions for the perfect storm, high value vaccines with high demand and low supply. This is a recipe for falsified products which will be distributed through both physical and online channels.  

 There is no single solution to solving falsified crime. If there were, we wouldn’t be facing the issue. What’s needed is a suite of capabilities and solutions in place to minimise the risk and take into account the national environment and needsPatients want this vaccine in their arm. It’s the key to reopening lives and economies. It will afford the vaccinated greater freedoms, and therefore strong demand existsConsequently, some patients will buy it illegitimately, whether just queue jumping or due to concerns over a lack of supply.  

One route for falsified product to enter the marketplace is via the internetI’ve written an article relating specifically to cybercriminal activity around these vaccines, whereby efforts to fight this crime are being made by organisations such as EAASM and ASOP, to raise awareness with consumers. This is where the high media profile of these vaccines is of benefit. It’s highly publicised that there is no extra out there, so unless your vaccine is secured via legitimate channels, it’s fake. Also, policing the sellers and monitoring cross border movements helps the effort

As well as tackling the illegitimate supply chain, we must also secure our legitimate supply chain. This highly valuable product is hugely vulnerable to theft and hijackingleading to the dangerous situation of spoiled batches in circulationThis is a particular issue in low-middle income countries. We need to put systems in place with monitoring efforts on the legitimate supply chain to ensure its security 

 

Q. With the desire to foster international travel, what is a Healthcare Passport for travellers? 

A.  A Healthcare Passport for the vaccinated would extend beyond just travel, it could mean individuals being able to work, attend a conference, or visit a care home. If we are granted more freedom or have more opportunities offered to us by being vaccinatedthen the evidence we carry becomes very valuable and therefore a target for forgeryMethods of proving vaccination in a failsafe way is a huge challenge.  For example, who confirms you’ve been vaccinated?  Staff at the centres are busy vaccinating and caring, so who keeps the recordsWe will need to create a link to the record of administration and who the patient is, relying on robust identification at the point of vaccination. All this requires further levels of administration and staffing.  

These passports are going to be really important if we’re going to get some industries safely back up and running, such as travel, leisure and entertainment industries. But how will we make them as secure as current travel passports or online banking for instance?  

 

Q. How can IoT enhance the potential business value of serialisation? 

A. Web enabling packs, where every pack can be treated as a unique thing with a unique identifier brings about huge benefits. This means you can leverage track and trace, but also can provide additional information about each specific thing by scanning to get to additional pack contentThis could be for example a leaflet in a different language, or the new expiry date. You can create use cases such as product verification to link to patient records.  

 

Q. How would you quantify the economic value of an investment in serialisation?  

A. The two main benefits of patient safety and supply chain efficiencies are hard to put an economic value on. Patient safety, the safe product correctly administered, means less stress on the healthcare systems. Unsafe product could result in legal action, people being removed from the workplace, damaged healthcare systems, reduced staffing and additional treatments, all at huge cost to society. Improving the efficiencies of your supply chain presents great economic value too. With COVID-19, the global economic cost has been extreme. A stronger, more visible supply chain for the vaccines will help us reopen societies and begin our recovery.  

 

This year I once again had the pleasure of attending, chairing and presenting at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18th and 19th June. Many thanks to Lucy Comer and the team at IQPC for organising the event.

I presented on the topic Managing Portfolio Complexity in Packaging – Dealing with Small Volume Products, looking at the growing challenge of complexity in packaging portfolios. As companies chase niche opportunities and products become more specialised, large volume packing runs are becoming increasingly rare. However, many pharmaceutical packaging facilities have been designed for higher volume product. Coping with portfolios dominated by small volume product significantly reduces operational efficiencies and drives a large hidden factory of support staff to maintain.

I reviewed some of the environmental factors causing this growth in portfolios and presented a three stage methodology to address the challenges of complexity. Firstly, the portfolio needs to be assessed and understood so that the characteristics and requirements of each SKU are clear. Secondly, sources of non-added value complexity need to be removed to standardise as much as possible. Thirdly, appropriate mechanisms, like postponement and late stage customisation, need to be introduced to provide the necessary complexity in a more effective manner. Finally, I reviewed the sorts of benefits in terms of efficiencies, lead times and costs savings that can be achieved by such a programme.

Other presentations from the event included:

The Role of Packaging and Labelling on Supply Chain Efficiency Prabir Das: Vice President – Packaging Development, Mylan

Prabir presented a broad overview of the interface between packaging and the supply chain. He talked about the commercial and environmental challenges facing packaging and how product characteristics impact packaging design and material selection. All of these issues should be addressed by the packaging system, which in turn should consider all of the requirements that need to be delivered by the packaging design. Prabir also talked about how packaging needs to protect the product, ensuring that the product is fit for use when it reaches the end-user. Finally, he looked at how technology will impact packaging in the future and what barriers will have to be overcome.

Evaluating the Use of Smart Packaging and Interaction with Smartphones Andrew Smith: Technical Packaging Director, GSK

Andrew presented on the use of smart packaging within the pharma industry. He discussed the benefits and opportunities presented by eLeaflets. Smartphone enabled leaflets permit the provision of enhanced product information, for example usage videos. Smartphones can also be used for alerts and compliance, security features and usage monitoring. This improves patient engagement and product security. Andrew reviewed the different types of technology that can be used as carriers to link to product information including tags, QR codes and barcodes. He highlighted the benefits and challenges of each technology and what potential application scenarios might occur.

Solutions to Optimise Your End-to-End Artwork Process Suzanne Ivory: Chief Operating Officer, Perigord

Suzanne presented on the challenges facing pharmaceutical artwork, particularly the impact on patient safety. She highlighted the need for clear processes with detailed instructions to ensure the desirable right-first-time outcome. The implementation of a comprehensive Quality Management System and the underpinning Artwork Management System are key capabilities to support the creation of correct artwork. She also discussed how the introduction of appropriate measures drives performance through focusing on addressing performance deviations. Finally, Suzanne discussed the areas of new technology emerging that will impact artwork processes and capabilities.

Ensure a Return on Your Investment by Implementing E-Labelling into Pre-exiting, Multi-functional Barcodes Tatjana Pathare: Senior Artworks and Regulations Specialist within the Serialisation Project, Roche and Christian Hay: Senior Consultant – Healthcare, GS1

Tatjana and Christian presented on the use of the serialisation barcode to provide a patient leaflet. They highlighted the opportunity of using GS1 Digital Link as the carrier for accessing the eLeaflet as it is an open standard platform. GS1 are now undertaking some pilots to develop this capability. Christian then followed up with a discussion on the ISO standard that is being drafted to support this use of the supply chain identifier to access digital information.

Digital Maturity Model for Packaging: Digitise, Automate and Connect in Pharma Simon Cavanaugh: Senior Account Executive – Global Business Group, ESKO and Steven Brookes: Solution Consultant, ESKO

Simon and Steve presented on the journey companies undertake to manage their digital assets in a comprehensive manner. As the volume of digital assets grows in a company, capabilities also need to evolve to manage assets effectively. ESKO has developed a roadmap tool to help companies with this journey. Simon also explained some of the different use cases they have witnessed for artwork introduction and reasons behind these process variations. Finally, Simon covered some of the other learnings ESKO have witnessed in client implementations, particularly around regulatory processes.

Maximise your Brand Engagement with Patient-centric Packaging and Understand How it Improves Patient Lives Gabriele Iannizzotto: Chairman, HCPC Europe

Gabriele presented on the work carried out by HCPC Europe and the annual Columbus Award for patient safety packaging. He discussed some of the numerous issues facing patients, which can be resolved through improved packaging design. He then introduced some of the previous winners of the Columbus Award demonstrating some of the patient safety / adherence features they included.

What’s Holding Us Back? Identify your Supply Chain Bottlenecks and Risks Jeffrey Hardy: Director General, TRACIT and Suriya Prabha Padmanaabhan: Director of Programs, TRACIT

Jeff and Suriya led a discussion on the issues attendees are witnessing with illicit trade across their supply chains. They looked at each step of the supply chain defining key issues, causes and impacts. This is part of a wider survey they are undertaking across many industry sectors. The outcomes will be captured in a cross-functional business report on illicit trade.

Challenges for Global Pharma Companies to Implement Anti-counterfeit Strategy for Russian Track & Trace Regulation Dr Ettore Cucchetti: Chief Executive Officer, ACG

Ettore presented on the development of secure supply chains across various industry sectors and territories. He compared the maturity of security activities in life sciences against other sectors and examined how capabilities are likely to develop in the life sciences sector. Ettore also discussed each of the elements required for a full product traceability solution.

Putting Patient Safety at the Heart of FMD Leyla Hannbeck: Chief Pharmacist & Director of Pharmacy, National Pharmacy Association

Leyla presented on the patient safety issues associated with packaging and FMD, as witnessed in pharmacies. In particular, she highlighted the significant amounts of 'look-alike, sound-alike' errors that happen and how improved packaging design could alleviate these. She presented a number of case studies highlighting the issues where dispensing errors had occurred. Leyla also discussed the impact of FMD on community pharmacies and the preparation activities that have been undertaken to date.

Serialisation and the Future of Hospital Pharmacy Robert Moss: Director of Professional Development, European Association of Hospital Pharmacists

Robert presented on the impact of serialisation and other technological developments on hospital pharmacies. He discussed the problem of identifying the point of authentication in a hospital pharmacy. There are a number of points within the hospital environment where is could be carried out from goods receipt to patient use and each presents challenges. Regarding other technological developments, Robert explained how aggregation would have a significant benefit to hospitals by avoiding having to scan each pack in a case. Scannable single dose primary pack barcoding provides significant patient safety benefits, and EAHP have been advocating this for a number of years. Finally, Robert showed some of the automated drug dispensing and delivery equipment that is being developed.

Fulfilling the Needs of the Local Market with Need-based Packaging Innovation Rajesh Mishra: Associate Director – Packaging Development, Abbott

Rajesh presented on the challenge of designing products to meet local market needs. Focusing on India, he highlighted some of the issues created in a market that is high volume but low cost, with a very high degree of competition. In this environment, needs-based innovation is key to defining how to differentiate your product. Rajesh showed a few examples of packaging design that were developed to meet these challenges. He highlighted a key learning which was making sure that the design of the pack or device was easy to understand and use across many different demographic groups.

EU MDR and its Implications for Labelling and Artwork Karolina Komposh: Labelling and Artwork Manager, Croma-Pharma

Karolina presented on the new Medical Device Regulations. She provided an overview of the regulations, some of the major changes that have been introduced and the timelines to be achieved. She then explained some of the issues that are being discussed between industry and the regulators. As can be expected by such a large piece of legislation, there are many details that need to be further worked to develop practical solutions and time pressures are making these issues more acute.

End-to-End Solution for Managing Labelling and Packaging Artwork Ray Collia: Senior Account Executive, Loftware

Ray presented a clinical trials artwork case study on an implementation undertaken by Loftware. He outlined some of the challenges in clinical trials that can impact the development of clinical trial artwork. He also gave an overview of the business issues that the case study company were wanting to address. He highlighted the benefits that can be delivered through a suitable labelling and artwork system and explained key features of the Loftware system.

Preparing for the Worst : Negotiating with Sites That Have Not Prepared for FMD and Anticipating Brexit Huda Awidi, Regional Regulatory Affairs Manager – Labelling & Artworks – Middle East, Africa, Turkey & Pakistan, Mundipharma

Huda presented on the impact of Brexit and FMD on Middle Eastern / African countries. This is a complex range of countries with many local requirements. She covered the actions being taken to prepare for potential Brexit scenarios which will impact many things including, for example, product licenses due to changes to sites of release. Huda also discussed the implementation of FMD. There is a strong pull in the countries she represents for a serialisation solution, due to the levels of counterfeit product, but countries are at different levels of development. Products are supplied from 60 CMOs so agreeing processes and procedures is difficult. As some countries are implemented and some are not it has also made it difficult to share packs. Finally, Huda explained the methodology they have used to implement serialisation across the region and highlighted key learnings from their implementation.

Morning Workshop: From Manufacture to Use: Overcome the Challenges Encountered during the Three Stages of the Packaging Lifecycle Prabir Das: Vice President – Packaging Development, Mylan

Interactive Workshop: Moving Beyond Compliance – Transitioning from Serialisation to Securitisation Mark Willis: MDR and Compliance, Johnson and Johnson

In addition to the presentations by the speakers above, Prabir and Mark held workshop sessions on the Packaging Lifecycle and Transitioning beyond Serialisation respectively.

It was a pleasure to chair such an informative and engaging two day event, tackling a wide breadth of topics, many of which are constantly evolving as the Pharma Packaging and Labelling landscape responds to many wider industry changes. Thank you to all the speakers and attendees for making a productive and enjoyable session. I look forward to meeting again next year.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

Should you have any questions or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

For more information on our areas of expertise, go to our free download section.

Throughout this blog series, I’ve been looking at how to optimise your packaging facility by balancing the product portfolio against packaging facilities. Optimisation is necessary and desirable as without it pharmaceutical packaging operations can be expensive, with non-optimal service levels, inflexibility and poor utilisation.

A balance can be found by addressing three key issues:

1- Ensure your product portfolio is appropriate

Product portfolios are becoming increasingly complex for many reasons. The following factors contribute to increasing portfolio complexity:

- The need to maximise value from current assets

- New products emerging for complex medical conditions

- Local market requirements

- Commercial advantage

Ensuring your portfolio is suitable for your packaging facility is key to achieving optimisation. These are my top tips to help ensure your product portfolio is appropriate for your facilities:

Tip 1: Understand the product/therapy strategy and value of complexity

Tip 2: Understand the portfolio, volumes and lifecycle of SKUs

Tip 3: Have clear approval and control processes for portfolio changes

Tip 4: Prune the portfolio regularly

Tip 5: Share components or packs

2 – Optimise your packaging facility design

Packaging facility equipment needs assessing right down to component level. Is the line spec suited to the product requirements? Is the facility suitably laid-out? How effective are the supporting business processes?

These are my top tips to help optimise the facility design, delivering optimal service levels at minimal cost:

Tip 6: Plan for runners, repeaters and strangers

Tip 7: Manage order quantities of components and finished packs

Tip 8: Utilise postponement

Tip 9: Utilise late customisation

Tip 10: Build flexibility into packaging equipment

Tip 11: Reduce line changeover time

Tip 12: Optimise supply chain design and hubs

Tip 13: Outsource where appropriate

3 – Ensure your product packaging is designed to meet the needs of the optimised product portfolio and packaging facility

Product packaging must be easy to use, meet regulatory requirements, protect the product and be robust for shipping operations. Packaging engineers and artwork designers need to consider the overall packaging supply system when developing their designs. These are my top tips to ensure the key attributes of the product packaging enables the most appropriate packaging solutions to be used:

Tip 14: Control brand variation

Tip 15: Control platform sizes

Tip 16: Standardise artwork templates and layouts

Tip 17: Minimise fonts, illustrations and graphical elements

Tip 18: Revisit existing packaging designs

Tip 19: Plan for future legislation

In conclusion, complexity is an underlying cause of inefficiency in packaging operations. Some complexity may be considered ‘good’ because it presents value as financial return from sale of the product. The key is to learn how to cope efficiently with this ‘good complexity’ whilst developing methods to control the other type of complexity – the ‘bad complexity’. Unfortunately, there does not seem to be any ‘golden bullet’ that will help you to do this easily. Rather, there are a series of techniques that can be applied across the operation to manage the complexity and optimise your operations.

Should you have any questions about this or any of my other blogs, if you would like to discuss the packaging complexities within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, examining the packaging facility design and looking at the key attributes of product packaging. In part four, I offered my top tips on optimising the packaging facility. Here in part five, I will be exploring the topic of product packaging, offering my top tips on standardising brand, component sizes and templates and the importance of looking ahead and planning for future legislation.

Tip 14: Control brand variation

Do you have a process to control the brand image and prevent unnecessary or undesirable proliferation of brand designs?

It is not uncommon for companies to have a range of brand images that have arisen historically:

• Locally generated brand names and brand images.

• Response to local market regulations requiring unique local naming or branding.

• Legacy brand images from acquired companies who once marketed the product in a specific country.

• 2nd brands or co-marketed products.

If standard brand images and packaging artwork designs can be maintained, it presents the opportunity to take a template approach to artwork, improving efficiency and reducing risk or error. This is discussed further in Tip 16. Many companies now exercise strict control over brand images and packaging designs at a global or regional level, to ensure they present a common identity to consumers. It is extremely difficult to rationalise brand images after the event, due to regulatory constraint and consumer resistance and therefore clearly defined and mandated brand guidelines are an important tool in controlling brand variation up front.

Tip 15: Control platform sizes

Do you define and maintain a set of standard platform sizes?

Components can come in multiple sizes and shapes and the challenge is how these can be controlled to an optimum number. Your approach to this will be heavily impacted by your supply chain design.

• If you have a few global or regional factories, rationalisation can be targeted at a local level.

• If you have a high number of factories supplying multiple dose forms to many markets, you will be presented with a significant number of inter-dependencies making rationalisation more challenging.

• If you purchase finished products from third parties, you may be restricted to each supplier’s standards.

Many companies will have combinations of all of the above, so your approach may be global, regional or by product/supply chain. For printed packaging components, the challenge is to reduce the range down to the smallest practical number of profiles. This gives less profiles to manage and will aid line change-overs. It is also a pre-requisite for most types of late customisation. Platform sizes are normally driven by the size of primary components and so it is often best to start with a rationalisation of primary component sizes and shapes to reach an optimum range of platforms. For other components, such as spoons and measuring cups, try to rationalise to the minimum number of variants.

Tip 16: Standardise artwork templates and layouts

Are there standard templates and layouts for artworks?

Standardising the brand image, packaging artwork design and component sizes, permits the use of standard artwork templates and layouts. In this approach, global or regional templates can be created including all the standard design content. Areas for specific market or regional content can be provided on the artwork and these can be populated when specific local variants are required, either creating market specific artworks or as part of an on-line printing activity with semi-finished components. This saves having to create a completely new artwork every time, which has obvious compliance benefits. It also ensures that areas such as overprint areas are always in the correct locations. Furthermore, it facilitates using tools to automatically add content to the template and automatically create the artwork.

Tip 17: Minimise fonts, illustrations and graphical elements

Are there defined standard fonts, illustrations, and graphical elements?

Artwork content such as fonts, illustrations and other graphical content can provide hidden sources of complexity. It is common for companies to build large ranges of content that need to be stored, maintained and updated. Proliferation of fonts may not seem significant, but licenses need to be managed and fonts need to be assured to ensure accurate replication across different platforms and machines. It also results in dilution of the brand image. To control fonts, a defined house style set of fonts should be mandated within the corporate and brand guidelines with clear processes for the introduction of new fonts. Similarly, illustrations and graphical elements should be held in controlled libraries with standard images for particular uses.

Tip 18: Packaging design

Have you designed your packaging to maximise the opportunities to deal with complexity?

All of the different techniques we have discussed in these tips offer opportunities for dealing with low volume products and managing complexity, but they may not be feasible with your existing packaging designs. It may therefore be necessary to revisit some of the structural or artwork elements of the design to exploit specific techniques. These can include:

• Changing component artwork to make it standard across multiple countries (or even removing all market specific information).

• Grouping all market specific information on certain areas of the artwork (like the EU blue box concept).

• Providing space on components and artwork for on-line printing requirements or application of labels.

• Reducing colours to make on-line printing easier.

• Changing component size to provide more printing space.

• Providing pockets or flaps on cartons for attaching leaflets and booklets.

• Standardising sizes, platforms, layouts and templates.

• Using colour coding, poka-yoke and pharmacodes or data matrix codes to aid control of assembly operations.

It is therefore important to ensure that a holistic approach to packaging design is taken, ensuring effective design for manufacture.

Tip 19: Plan for future legislation

Are you already planning for how you will introduce required future legislation?

No matter how well you manage your current portfolio, there will always be new challenges to drive further complexity. New aspects of legislation will arise, requiring new solutions to provide. At the time of writing these included:

• QR codes

• Serialisation

• Tamper evidence

• Temperature monitoring

It is therefore worthwhile planning ahead for future legislative drivers and considering:

• How well are you sensing what is likely to happen in the future?

• What changes do you want to influence and how are you engaged in that influencing?

• How early do you mobilise to start introducing new capabilities?

• What alliances and partnerships do you need to establish to develop new solutions and supply strategies?

• How do you integrate necessary changes into normal business to avoid the incremental workload?

• How do you ensure packaging design activities are cognisant of potential future requirements?

• How do you track progress to ensure compliance is achieved?

In the next and final part of this blog series, I’ll be pulling together our learnings on packaging complexity and examining the different types of complexity.

Should you have any questions about this or any of my other blogs, if you would like to discuss the packaging complexities within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, optimising the packaging facility design and examining key attributes of product packaging.

In part three I offered my top tips on what should be considered to drive maximum value out of your packaging portfolio. Here in part four I examine the packaging facility and offer my top tips on optimising the facility design to deliver optimal service levels at minimum cost.

Tip 6: Plan for runners, repeaters and strangers

Do you have capability to supply product with different order and volume profiles – runners, repeaters and strangers?

Products can be classified into three groupings:

Runners: products that are produced very regularly.

Repeaters: products that are produced or packed frequently, but not every week or month.

Strangers: products that are produced very infrequently.

The concept of runners, repeaters and strangers provides an excellent method for production scheduling and supply chain management. Runners typically provide the bulk of the stable packaging volume permitting high line run times and often dedicated equipment. Repeaters don’t justify dedicated equipment but occur frequently enough to allow scheduling with runners and are still packaged in reasonable batch sizes. Strangers present a greater challenge as their infrequent nature and small overall volume make them challenging to build into the production schedule, produce in economic batch sizes and manage component supplies. Supply sites will normally have to produce products for all three groupings, and increasingly an individual brand can have all three types of product. It is therefore necessary to have the capability to schedule and pack all three. The application of many of the techniques presented in this blog to minimise variation, increase pack or component sharing, or introduce postponement or late customisation techniques, can assist in managing the disruption created.

Tip 7: Manage order quantities of components and finished packs

Have you got processes to effectively manage order quantities of components and finished packs?

Considering the previous tip on runners, repeaters and strangers, it is important to consider how volumes of components and finished products are managed through the supply chain. Packaging operations are under high degrees of pressure to maximise efficiency. Where high volume runner products are present it is easy to produce in economic batch sizes and purchase commercially advantageous volumes of components. However with stranger products, the preferred packaging batch sizes can often result in high levels of inventory of finished packs which are at risk of obsolescence through shelf life expiry. Often this results in repackaging activity to move product from one market to another prior to expiry. In addition, the economic order quantities of packaging components can often result in high stock levels of components that have to be written off when a pack change is required. It is therefore important to manage two dynamics to minimise the risk of obsolescence:

1. Maximise the order volumes through pack or component sharing or postponement or late customisation techniques to increase stock turns.

2. Consider the whole activity cost in setting economic batch and order sizes and thus reduce the batch and order volumes.

Tip 8: Postponement

Can you postpone customisation to as late as possible in the supply chain?

There are a number of definitions of postponement, but the one we will use here is the delaying of customisation of a product until as late as possible in the packaging operation. There are many examples of this:

• Filing blank bottles or cans for stock and labelling when fulfilling a specific order.

• BIB/BOB (blisters in boxes, blisters out of boxes) e.g. producing standard blisters for stock and packing into cartons at a later stage to create market specific packs.

• Assembling different combinations of standard components to create a unique pack variant for a specific market.

In all cases it can be seen that the goal is to keep the product as standard as possible for as far through the packaging operation, and then only make it market specific at the latest possible operation, perhaps against a specific market order.

This can present a number of challenges for most operations:

• Additional quality system control to manage intermediate handling and subsequent further packaging operations.

• With fill and pack lines it can be necessary to remove the product part way through the operation and then run it down the line again at a later time to complete the packaging.

• Hand packing can be required for the final assembly of small batches.

• The design and characteristics of some products and components makes it very difficult to avoid making market specific until late in the process.

Tip 9: Late customisation

Can you late customise components and products?

Our definition of ‘late customisation’ is the physical modification of standard components and products to add features or information, making them product or market specific. Examples would include on-line printing of content and over-labelling and may be undertaken downstream of the packaging facility.

On-line component printing is becoming increasingly common but depends upon the type of component and information required:

• On-line printing of foils and labels is often undertaken, particularly if only requiring black ink.

• Equipment for near-line short-order printing of leaflets and booklets is becoming available.

• On-line printing of multi-colour cartons (particularly pre-glued) is more complex with fewer examples, although digital presses are increasingly used at print suppliers for short runs. Over-labelling can vary between simple printed labels (pharmacy labels) to complex labels (e.g. including sealed pouches for leaflets).

A few considerations with late customisation and over-labelling:

• How do you assure the quality of print for all components? A missing decimal point could have significant consequences.

• How do you ensure the line speeds are not significantly impacted? Is near-line printing a better option?

• Do on-line printing machines require different artwork files or formats? Where are these files stored and how does that impact your artwork process and system uptime?

• Can your MRP system provide the necessary breakdown of SKUs and components?

Tip 10: Build flexibility into packaging equipment

Have you got the right type of packaging equipment that provides suitable levels of flexibility?

It is often tempting when specifying equipment to specify the fastest packaging lines. Indeed, due to being pressured for ever increasing levels of efficiency, most packaging operations would love to be producing high volumes of few variants as fast as possible. However, as we have discussed, the healthcare marketplace is increasingly not like that, as volumes are decreasing and complexity is increasing. It is therefore important when specifying packaging equipment to ensure that the correct criteria for how the portfolio needs to be supplied are defined and agreed. Trends are driving this towards much more flexible machinery that can be easily changed for different pack formats, with the ability to insert specific modules when required (e.g. serialisation printing modules), or the ability to split fill and pack lines to permit part packing. Due to the capital costs required, it is unlikely to be feasible to reequip packaging facilities at a later date. Therefore, making the right choice of equipment to support your expected portfolio and supply strategies is a critical strategic decision.

Tip 11: Reduce line changeover time

Have you maximised your opportunities for fast changeover?

Line changeovers are non-productive time and in a world of increasing complexity and product variants, the amount of changeovers increases and so lines can spend significant amounts of time not producing product. This reduces capacity and increases cost. There are three parts to a changeover; clean-down, set-up and startup, and all can be improved through the application of operational excellence techniques and product and equipment design. There are four steps to consider and many opportunities with each:

Eliminate non-essential operations: for example standardise component sizes, reduce the range of tooling, equipment modifications like adjusting only one guard rail instead of two.

Perform external setup: for example have all of the changeover materials and equipment ready before you start, use pre-assembled modules.

Simplify internal set up: for example use quick couplings, scribe marks, jigs, hand knobs rather than nuts and bolts.

Measure and improve: continue to look for opportunities, hone your process and keep training. A changeover should be like a racing car pit stop.

Tip 12: Supply chain design and hubs

Have you optimised your supply chain to provide required levels of variation and customisation?

In coping with complexity, it is necessary to think not just of what must be done and how, but also where. To minimise obsolescence the goal should be to make products and components market specific as late in the supply chain as possible. To achieve this, a different approach to the design of the supply chain may be required. Postponement and late customisation activities are production activities and therefore must be undertaken with appropriate GMP processes and facilities. You therefore need to ensure that such operations are being undertaken with appropriate levels of control and therefore undertaking such tasks within warehouse operations may not be appropriate. Conversely, as most markets are supplied from many packaging facilities, providing the local market-specific requirements from each factory can be an unwelcome complexity burden at each factory. Ensuring that activities are undertaken at the appropriate points in the supply chain is therefore another key part of managing complexity. The concept of regional hubs can help provide appropriate solutions, where the hub supplies a group of local markets with market-specific product created from a stock of standard and customised components supplied from the factories.

Tip 13: Outsourcing

Have you considered outsourcing the things you are not best equipped to do?

Another facet of the design of your supply chain is the ‘make or buy’ decision. It may be tempting to try to keep all of the volume in house, but considering the concept of runners, repeaters and strangers, you may not be best equipped to deal with all. If you have a high-volume facility, it may be better to outsource the strangers to a packaging third party who can cope with an unpredictable product and infrequent orders. Alternatively, you may want to keep all of the specialist and unusual product in house and outsource the standard and repetitive volume. Also, considering the overall supply chain design, there may be geographic areas where you want to customise product but don’t have internal facilities available locally. An outsourced partner may be able to provide an appropriate regional hub. The important consideration is that you don’t have to do everything yourself and external partners may be better suited to solving the challenges you are faced with.

In my next post in this series, I will be exploring the topic of product packaging, offering my top tips on standardising brand, component sizes and templates and the importance of looking ahead and planning for future legislation.

Should you have any questions about this or any of my other blogs, if you would like to discuss the packaging complexities within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, optimising the packaging facility design and examining key attributes of product packaging. In part two, I looked at optimisation of the packaging facility, the impact of packaging design and the consequences of mismanaged complexity. Here in part three, I will be offering some top tips on what to consider to drive maximum value out of your packaging portfolio:

Tip 1: Understand the product/therapy strategy and value of complexity

Is the commercialisation strategy for the product and therapy and the subsequent value of complexity understood?
Different products will have different requirements for the complexity of the packaging componentry and SKU portfolio. This can be driven from many factors, including but not limited to:
• Therapeutic, titration and dosing requirements
• Unmet medical needs
• Legislative requirements of the countries into which the product will be marketed
• Competitor activity and the competitive environment
• Commercialisation strategies for the product
• Market positioning and product cost profile
• Product life-cycle, line extension and patent expiry strategies
• Combination products, starter packs, special usage requirements and other opportunities to drive adherence and assist patients and healthcare providers
• Product protection, temperature and security requirements
• Local dispensing requirements

Prior to undertaking any complexity optimisation activities, it is important to understand and document these requirements to:
a) Ensure they are clearly defined and met
b) Ensure they are maintained as needed
c) Ensure appropriate control can be provided to prevent further non-essential requirements emerging

Tip 2: Understand the portfolio, volumes and life-cycle of SKUs

Is the portfolio, volumes and life-cycles of your SKUs understood?
The next step in a complexity reduction activity is a detailed understanding of the target SKU portfolio. The scope of this may be certain brands, geographic areas, supply chains or perhaps your entire company portfolio. For the chosen portfolio, you will need to understand:
• The description of each SKU – product, dose form, strength, volume.
• Where are they supplied from? Which market(s) are they supplied to? Which distribution lanes are used?
• What is the subsequent component range?
• What are the SKU volumes?
• What is the financial contribution of each SKU?

In addition, it is important to understand where each SKU is on its product life-cycle; are volumes increasing or decreasing? Typically, products go through a standard life-cycle: launch, growth, maturity, and tail off. The value of portfolio complexity often varies through this life-cycle. Therefore, it is important to understand where a product is on its life-cycle as products where the volumes are likely to increase need to be considered differently from tail products where the volumes are declining.

Tip 3: Have clear approval and control processes for portfolio changes

Do you have clear approval and control procedures for adding and removing SKUs from your portfolio?
Firstly, do you have the appropriate cross-functional governance to ensure that all relevant impacted parties are engaged in the decision making and represented appropriately at a senior level? Failure to have a balanced governance will likely result in sub-optimal decisions and low levels of buy-in. Secondly, do you have a clear set of principles endorsed by the senior governance team to manage the portfolio? These define the ‘rules of the game’ and set the criteria that decisions should be made against. Thirdly, do you have rules and processes in place for adding or deleting SKUs and components? These processes need to ensure that the decision-making hierarchy aligns with the complexity of change occurring. Processes should also include routine reviews of the portfolio (see Tip 4). Finally, do your processes ensure that the costs for change are considered in decision making and preferably charged to the groups in the organisation driving those changes? For example, charging the cost of artwork change to the originator.

Tip 4: Prune the portfolio regularly

Is there a regular process to review the portfolio and prune unnecessary or non-performing SKUs?
The performance of the portfolio is dynamic, changing due to many environmental and life-cycle factors. Therefore, a review process should ideally be performed on a routine and repeating basis to maximise the effectiveness of the portfolio. The review should be designed to categorise the portfolio. One way we would suggest is these three groupings:

Capitalise: the best performing SKUs, those contributing most of the revenue, where sales efforts should be focused to maximise return.
Control: SKUs that should be maintained in the portfolio, either because volumes are growing, but not yet providing revenue to get to the next category; volumes are in decline, but not yet critical; or they provide portfolio support to other Capitalise SKUs. These SKUs should be monitored to ensure on-going viability.
Challenge: SKUs with low volumes and/or low revenue. These SKUs should be subject to challenge to remain on the portfolio, either being discontinued, substituted or shared with other markets.

Two things to consider carefully:
• When substituting SKUs, ensure the financial benefit exceeds any potential lost sales.
• Small incremental reductions in the portfolio can have little effect on complexity at supplying sites. Savings are often only generated when lines or facilities are rationalised or eliminated.

Tip 5: Share components or packs

Are you maximising the opportunities to share components or finished packs?
Shared components and packs can provide a great opportunity to increase component and pack volumes. However, to make this happen it is necessary to identify markets and products that can successfully share components or packs. There are a number of criteria that you should consider when looking to group markets for sharing. These include geography, languages, regulatory rules, regulatory approval timelines and sale price. Choosing markets to share products needs to be considered carefully as it requires close collaboration between those markets when changes are being implemented. Therefore, it is better to have consistent groupings of markets rather than vary the sharing groups by different product. Standard market groupings also simplify the ‘where used’ assessment during the change impact assessment. A significant challenge with shared packs comes when there are different approval timelines or locally driven changes. This can result in more than one version of the shared pack being required; effectively driving you back to market specific packs.

In my next post in this series, we will look at some of my top tips for optimising the packaging facility design to deliver optimal service levels at minimum cost.

Should you have any questions about this or any of my other blogs, if you would like to discuss the packaging complexities within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, optimising the packaging facility design and examining key attributes of product packaging. In part one I looked at portfolio complexity and the impact of portfolio on packaging operations. In this my latest post, I address optimisation of the packaging facility, the impact of packaging design and the consequences of mismanaged complexity.

Optimising the Packaging Facility

Often the first issue within the packaging facility can be the packaging equipment itself. Old, unreliable equipment that is slow to change over might just need to be upgraded. However, it may not be the whole line that is the issue. Packing lines consist of numerous components, each doing part of the packaging process. The overall reliability and speed of the line is a function of the reliability and speed of each component. Replacing one part may beneficially impact the overall line performance.

It is also worth considering the line specification versus the product requirements to be packed. We often see complex, high speed, automated and highly integrated packaging machinery being used for low volume short run packaging batches and can also see manual lines being used to pack larger volume SKUs. A more flexible line may be more appropriate.

Facility layout can also impact productivity. Many packaging facilities evolve over time. How is the flow of materials in your facility? Is there unnecessary handling or waiting? Where are there bottlenecks? Where are you wasting time and effort?

Finally, consider the effectiveness of business processes supporting packaging operations. Are processes optimised and efficient? Moreover, are the collective cross-functional processes tuned to work in unison or do dependencies between processes promote delays wasting time and effort?

Is the product packaging designed to meet the meet the needs of the optimised product portfolio and packaging facility?

There are many competing requirements to be considered when designing the product packaging. It must be easy to use, meet regulatory requirements, protect the product and be robust for shipping operations. It also must play its part in ensuring the most appropriate packaging solutions can be used.

Packaging techniques such as late stage customisation and postponement may have specific requirements for structural and artwork design, and these might require different solutions to those typically applied. Packaging engineers and artwork designers need to consider the overall packaging supply system when developing their designs to ensure they are fit for different solutions that may be applicable for different volume profiles.

There are consequences to a company when complexity is not managed appropriately

Packaging complexity creates some consequences for companies and their customers, including:

1) Compliance issues: Correct products and components must be supplied to the correct markets with the latest approved product information. With ever-increasing portfolio complexity, exercising appropriate jurisdiction control over what is supplied and to where, gets more difficult. Many companies have tried to overcome this complexity by supplying smaller markets with standard ‘general export’ type packs, only to find unexpected and uncontrolled local repacking. This practice obviously presents an unacceptable compliance risk if not managed effectively.

2) Lost commercial opportunities and product unavailability: Sometimes the financial trade-off between suppling a unique pack variant to a market versus the cost of supply doesn’t merit selling that product in that location. That may be considered a victory in minimising complexity, but it is a lost commercial opportunity leaving patients in that market unable to benefit from that product being made available to them. It is therefore a hollow victory that could be avoided if the company had more cost-effective capabilities to supply such variants.

3) Packaging inefficiencies: Small volumes mean small pack runs and lots of changeovers. We have seen examples where the packaging line spends more time being changed over than packing product. Complexity can also create needs for specific additional tooling, equipment and hand finishing.

4) Support function inefficiencies: There is a whole ‘hidden factory’ in the support functions supporting the product and component range e.g. additional regulatory staff maintaining licenses and product information or more purchasing activity. This is often invisible and not considered in the cost of supply.

5) Obsolescence: There are two relevant types of obsolescence; packaging components and finished product. Economic order quantities result in purchased volumes of packaging components that have a disproportionate amount of forward cover, causing high amounts of write-off when components change. Similarly, high inventories of low volume finished pack stock, caused by minimum packaging order quantities, risks either product write-off or repacking due to shelf life expiry.

In my next post in this series, we will look at some of my top tips for ensuring your product portfolio is appropriate for your packaging facility.

Should you have any questions about this or any of my other blogs, if you would like to discuss the packaging complexities within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]