As deadlines for pharmaceutical serialization in the US and Europe loom closer, one thing is clear: serialization is a complex task that requires some serious thinking time and preparation. But what are the five core considerations to keep in mind as you start, or continue, your journey to serialization compliance?
- Drill down to the detail
Serialization is not simply an engineering, carton layout or IT project – it is all of these and more, impacting all aspects of interaction with the supply chain and all departments within the organisation, including the warehouse, quality assurance (QA) and human resources (HR), to name just a few. Map out each of your product’s lifecycles from A to Z and get to grips with how many production lines will be affected. It might also be necessary to upgrade and possibly replace your packaging and printing equipment, as well as engage a cloud provider to store your serialization data. Before you can tackle the challenge head on (accesss for free our webinar Overcoming the challanges of implementing Serialisation), you need to first understand exactly what you are dealing with.
- Select the right partners for you
Implementation partners can help you to map out, manage your serialization project and navigate the complex web of global track and trace regulations. You will need a plan to generate unique random codes for all of your products. Using their user requirements specification (URS) documentation, companies should create a roadmap of strengths and weaknesses for each vendor. It’s important to look for scalable solutions based on a modular approach to be sure to purchase a serialization solution that will meet the varying requirements over the coming years. Be sure that the chosen serialization vendor provides technical and training support services to manage the transition period during and after the go-live date.
- Engage and educate
Change will come from many directions with the introduction of serialization capabilities. A company-wide training programme should be put in place for the people who will be impacted by the new processes, technologies and ways of working. Whether you’re a pharmaceutical contract manufacturer or big pharma firm, you may also have multiple partners and/or customers that you will need to engage with early to ensure a cohesive approach and seamless adoption of the necessary changes.
- Look to the future
When it comes to track and trace requirements, it could be said that change is the only constant. Global regulations will continue to evolve, so always think about the future implications of the processes and technology you deploy. Any solutions you purchase as part of your project are likely to continue to change for the next five years. This means you will need to make the process of receiving, testing and releasing changes to your manufacturing sites and enterprise systems as flexible as possible. You should also consider how your serialization vendor can support you in the long-term. Do they have an internal team for on-site an on-line support to find fast resolutions to problems and avoid unexpected line downtime? Will you make use of an experienced third party support team to capture and share learnings and continually improve your operations?
- How can we do things better?
This is a point that is all too often forgotten when new systems and processes are introduced into organisations. Serialization should be seen as an opportunity to introduce standardised and modernised approaches. This could include standard ways of working, training materials and resources, responses to faults, maintenance and support and best practice generally. As well as achieving compliance, a serialization project can deliver return on investment (ROI) through greater visibility of your supply chain, reduction of grey market losses, fewer recalls and improved product quality. Periods of change usually bring about great opportunities. Be sure to make the most of your serialization project to deliver long-term benefits to your organisation.
To find out more about how we can help you on your serialization journey, contact us today.