Pharmaceutical product serialisation is being introduced across the world to prevent fraud and improve patient safety. Achieving this across your company supply chain has the potential to be a costly and complex undertaking. In this first paper of two, we provide a series of six tips as we cover the key areas to consider, and we believe using these learning points when devising your serialisation strategy will reduce your risk and ensure a successful implementation.
In LOGFILE 03/2018 we provided the first two of six tips as the key areas to consider to reduce your risk and ensure a successful implementation. Today you'll read the next four tips on capacity constraints, cross-organisation impact assessment, understanding of true complexities of your supply and globally capable solutions.
For many years, there has been a great deal of uncertainty in the implementation timing of certain legislation requirements, and legislators have often delayed deadlines. This has had a knock-on effect on the solution providers. Understandably, they have been reluctant to commit to expanding their businesses until they were confident that the customers would require the capacity.
To date, this has often meant that, particularly in the enterprise solution space, actual capacity and development activity has been limited. Indeed, whenever legislative deadlines have approached in the past, it has been clear that the vendors quickly became capacity constrained, with availability of key staff being highly restricted and noticeably extending delivery lead time.
With implementation dates in the US and EU looming, vendors are reporting significant expansion to meet the anticipated demand. Whilst this is very good news in terms of the capacity it will create, there are two related issues that will likely spin out of this. Firstly, it is very challenging to rapidly expand any business without impacting the quality of products and or service. Secondly, the expansion is being carried out to meet an anticipated significant increase in demand and, therefore, this new capacity is unlikely to do anything more than meet this additional demand.
Therefore, we recommend ensuring that any serialisation plan be built using conservative lead time estimates and that capability implementation be phased. Also, consider avoiding plans that call for significant capability implementation in the 2017/18 time period. We predict this period will be highly challenged, much like dealing with the Y2K issue in 1999.
To successfully implement serialisation solutions, pieces of capability need to be implemented across many functions and geographies in an organisation. More often than not, pharmaceutical companies also need to ensure that capabilities are implemented in many third-party supply chain partners as well. Impacts on such aspects as products, countries, supply chain nodes, supply chain partners, supply chain processes, and information technology systems all need to be considered.
Given the long lead-times and complex interdependencies between the different elements of the serialisation capabilities, we have found it essential to ensure that an early and comprehensive impact assessment is carried out and then acted upon.
Furthermore, serialisation requirements and typical pharmaceutical companies are constantly evolving. Therefore, there needs to be a mechanism in place to ensure that any impact assessment is reviewed regularly to ensure changes are adequately addressed in a timely manner. It is our experience that relying on established business processes, such as change control, do not provide a timely or robust mechanism to achieve this objective.
To implement effective solutions to address serialisation, it is important to understand the true complexities of the product/supply chain mix. Many day-to-day realities of a modern pharmaceutical supply chain can present significant issues to serialisation implementation activities if not understood early.
Situations such as local re-labelling and kitting activities; sale of product packs into one market which are designed and manufactured for another; locally driven cross-market supply; and multi-market presentations can all present significant challenges.
Also look for situations where your organisation is acting as a contract manufacturer for another company. In this type of situation, you will be faced with integrating your solutions into the serialisation model of your customer. This is an area where standards and solutions are not well developed in many instances.
Furthermore, the high cost of implementing serialisation capabilities means that it is sometimes appropriate to change the supply chain to reduce cost. This type of change often requires significant time to achieve and, in the case of such things as regulatory approvals, is not always within the control of the pharmaceutical company.
With the drive to implement initial solutions quickly, it is often tempting to “keep things simple” by selecting and implementing solutions that are only capable of meeting the immediate or limited requirements. Clearly, tactical solutions of limited scope and or capability have their place. If nothing else, they may be the only practical way to meet short-term legislative deadlines in some cases.
We have experienced several instances where initially selected tactical solutions become the company standard by default over time, despite the fact that these solutions were not originally selected for a broader capability and or geographical scope. This often creates significant issues to subsequent implementations which could have been avoided.
We, therefore, recommend resisting the temptation to rush into implementing short-term tactical solutions wherever possible. Where this is necessary, some mechanism should be put in place to review their suitability in the face of expanding requirements and allow switches to more appropriate solutions if necessary in a timely manner.
In this article, we have talked about the need for corporate sponsorship for a corporate-wide issue, to select solutions that are globally capable whilst recognising that the supply base is already overstretched and some solutions are immature. The increased complexity of global solutions will potentially place greater strain on your chosen suppliers. We also discussed the need to understand the true complexities of your supply chain and the need to undertake robust impact assessments across the organisation. Without fully understanding your operation and the impacts upon it from serialisation, you risk implementing suboptimal or even incomplete solutions. In the next article, we will look at the further Learning points 7 to 12.
We hope you find this information useful. We are always searching for ways to improve our work, so of you have any feedback, please do not hesitate to contact us at email@example.com.
Stephen McIndoe is a Vice President at Be4ward and works with global healthcare companies to create award-winning world class packaging labelling and artwork capabilities. He is also co-author, with his colleague Andrew Love, of the book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.
Andrew Love is also a Vice President at Be4ward. He was previously Head of Global Packaging Design at GlaxoSmithKline.
‘This article, ‘Key Learnings from Serialisation Projects’ is reproduced from a recent issue of gmp review, a quarterly journal researched and edited by an expert team experienced in all aspects of pharmaceutical manufacturing and control.
gmp review provides in-depth analyses of international pharmaceutical manufacturing regulations.
gmp review keeps readers up to date on the latest Directives, Regulations and Guidelines applicable to the pharmaceutical industry from the FDA, EU, CPMP and ICH positions. Each item comes with analysis and comment on its effect on your company. The dry legal jargon is made understandable to you and your colleagues in manufacturing and quality. As such gmp review is the perfect companion to the GMP Compliance Adviser and will help provide further useful commentary on the new regulations.
If you are involved in any aspect of GMP then gmp review will provide much needed information and analysis in a convenient quarterly journal format. gmp review subscribers will also receive gmp-review news a monthly news service to keep you up-to-date on new developments in GMP and associated regulations.
For further information on the GMP Review please click on the following link: