Last week I introduced my new blog topic for the next few weeks; important tips that are intended to help guide you while undertaking your new serialisation program or project.
Serialisation is a cross-functional, and in many cases in a typical pharmaceutical company, cross-organisation endeavor, requiring all parties involved to play their part in a coordinated and timely manner. To achieve this in any organization, it is typically necessary to have the appropriate level of top level sponsorship.
For serialisation to be successful in protecting patients from fraudulent product, the serialisation information must align with the product in hand, if not, it will have to be stopped. Errors in systems will lead to legitimate product being stopped. At best, an investigation will clear the product of suspicion at a later time. At worst, legitimate product will have to be destroyed. In either case, the product is either temporarily or permanently unavailable for sale.
Whilst we would always like to be in a situation of motivating action with incentives rather than threats, this potential unavailability of product for sale at some point in the supply chain needs to be understood by the relevant executives. It should be used to gain appropriate cross-functional and, where appropriate, cross-organisational sponsorship.
Furthermore, governance needs to be put in place across all the parties involved to ensure that decisions are made and activity is coordinated in a manner that will lead to timely implementation of the end-to-end solutions. In the lack of such governance, it is all too easy for local teams to make their own interpretations of legislation, define solutions and timelines in isolation, resulting in the end-to-end solution that does not work.
I hope you enjoyed this first tip on Things we wish we had known before starting a serialisation program or project. Please check back in next week for the continuation in this series.
Should you have any questions about this or any other of my blogs, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.