Tip 4: Understand the immature and evolving solution supply base and select appropriate implementation partners for EU FMD
Serialisation legislation is relatively new to the pharmaceutical industry and therefore the solutions available from the supply base are correspondingly immature and in many cases evolving. Supplier selection will often be the start of a very long relationship, as solutions that are initially implemented will need to be supported and adapted to new requirements over time. There have already been several examples of suppliers that have come and gone as legislation has evolved or been delayed. Understanding the supply base and choosing the most appropriate suppliers will be critical to long term success.
Defining complete requirements covering all aspects of the solution’s lifecycle and then realistically judging the supplier’s ability to meet these requirements also presents challenges.
Tip 5: Resource implementation projects with sufficient serialisation specific knowledge to minimise the risk of wasted resources, delays and implementation failure of EU FMD
The specific challenge during the design, build, test and implementation phases of solution projects is to resource them with sufficient serialisation subject matter skills and knowledge to avoid common pitfalls, reduce wasted effort and the risks of delay and solution failure.
Organisations need to plan for these resource requirements, build sufficient capabilities internally and secure access to sufficient external resources where appropriate.
Tip 6: Compare your global and local requirements for EU FMD
The question of global versus local needs to be considered on several different dimensions.
Firstly, there is a need to consider what is being standardised. There are some elements of the strategy and resultant solutions that need to be defined, built and operated at a global level so that all supply chain nodes can be supported. Other capabilities may need to have globally defined standards, but the build and implementation can be addressed locally. In other cases, it may be appropriate to direct all of the activity to local teams if there is no network-wide impact from locally generated solutions. Typical topics where the degree of standardisation needs to be considered include:
- Solution Selection
The second consideration is where serialisation activities are to be undertaken. Again, there will be a mix of global, regional or functional or local answers to where you are doing things. For example it may not be appropriate for all supply chain nodes to be individually tracking emerging legislation, but also packing operations are likely to stay at local supply chain nodes.
The final consideration is to what degree is the resultant capability global or local. Maintaining the number management systems is likely a global capability whereas maintaining the on-line printing and verification systems is more likely to be local.
In order to ensure that the capabilities required are appropriately specified and managed through their lifecycle understanding and agreeing what is done globally, regionally or functionally and locally is a key success factor in your EU FMD serialisation strategy.
Tip 7: The need for flexibility beyond EU FMD implementation
Serialisation legislation and responses are emerging across the globe from multiple different parties. Whilst often based off standard building blocks, the detail of the requirements shows significant variation. Whilst this is frustrating and a global set of common standards and solutions may be more cost effective, it is the reality of the situation and companies need to develop solutions to cope with it. Therefore, many companies have held back from progressing their EU FMD serialisation projects for fear of developing the wrong solutions or backing the wrong technologies.
Furthermore, capabilities required to deliver additional benefits from serialisation capabilities installed initially to meet legislative requirements also need to be considered.
Therefore, when developing your EU FMD serialisation strategy, you need to be thinking of, not just known, but also emerging and likely requirements. Solutions designed need to have a sufficient degree of flexibility to be able to cope with these requirements. This is not easy, but is a key challenge that must be made aware to solution design teams.
It is crucial that your company has a comprehensive, robust and realistic plan in place to deliver EU FMD serialisation and avoid product supply issues. If you don’t have such a plan in place, act now – contact Be4ward to understand how we can help deliver your strategy and plan quickly, with minimal impact to your team. Should you have any questions about the EU FMD legislation, or would simply like to request a copy of any of our serialisation booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com
For more information on serialisation, go to our free download section.