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.