Welcome to part 2 of my Key Learnings on Avoiding The Supply Risk From Serialisation With CMOs. In part 1, I introduced the first six learnings, looking at the unique relationship between Pharmas and their CMOs. Here in part 2 I consider six more learnings, focussed on processes and resource within the Pharma company.
Key learning 7: Make sure you have sufficient Plan Bs
Given the immature and evolving nature of serialisation and the over-stretched supply base, things are undoubtedly going to go wrong.
Any successful CMO implementation programme is going to rely on one or more alternative solution in order to get to the finish line successfully. Some of these alternatives will likely be tactical in nature and require subsequent projects to make them good.
A Pharma company would be well advised to plan key mitigation options ahead of time, as these may require specific capabilities being put in place ahead of time. Furthermore, there needs to be a clear and timely decision process in place to trigger the implementation of any ‘Plan B’, adapted plans and redeploy resources accordingly.
Key learning 8: Ensure you have a cross-functional team on this from day one
There are many interdependent decisions to be made and multi-functional activities which need to be done for any single CMO implementation to be successful. This is a cross-functional activity, typically including representatives from a number of groups, including:
- External manufacturing
- Key serialisation vendors
- Packaging engineering and technology
- Supply chain management and planning
- Regulatory affairs and artwork management
- IT Technical to create/manage technical interfaces
- Computer system validation
- Procurement and legal
Making sure that all these stakeholder groups within your organisation are engaged early and understanding their role and the resource levels that will be required is key to success. Then, for each individual CMO integration project, the identification of the cross-functional teams from each organisation need to be agreed, as well as how they will effectively communicate with each other.
Key learning 9: Don’t believe that the software vendors can sort this out for you
One of the things that must be done for serialisation to be successful is the interfacing of two or more IT systems. Your serialisation system(s) must talk to each CMO system(s) in near-real-time.
As part of their sales ‘promise’, the enterprise (Level 4/5) serialisation system vendors may lead you, or members of your team, to believe that they manage the whole CMO integration process for you. Whilst your system vendor undoubtedly plays an instrumental role in making the system interface(s) happen, the scope of any one CMO integration is far more than just connecting two IT systems. Often the interface will need additional master data to be exchanged and you need to understand and agree any master data impacts.
Furthermore, even if the scope was just limited to connecting two IT systems, the decisions that go into the underlying business processes and information passed between the systems has implications far beyond IT alone.
Key learning 10: Standard ways of working are valuable, but only guidance for wise men
Given that there is a significant amount of repeat work involved with integrating multiple CMOs, there is no doubt that having a standard, template model for the way in which you intend to deal with each CMO is an excellent starting point.
However, given that each company involved in this endeavour has their own set of external and internal constraints, the actual way of working with each CMO needs to be adapted to suit the particular situation. The project teams need to recognise this and tailor ways of working and plans to deliver the best compromise for all involved.
In our experience the discussions between CMOs and customers need clear leadership, making sure that you have the right person leading the discussions.
Key learning 11: Make sure that there is enough of the right resource engaged on the problem
Projects are only successful if there is enough of the right resource available at the right time. Serialisation is certainly no different.
Furthermore, because of the different organisations involved in each CMO integration and the immature and evolving nature of serialisation, it is likely that repeat activity will show some improvement in efficiency however, perhaps not as much improvement as might otherwise be expected.
The other significant issue with serialisation over the next few years is the fact that the experienced serialisation resources and the equipment and IT system vendors will be highly stretched to meet the demand.
Key learning 12: Make sure your internal RACI is clear
For the purposes of this discussion, by RACI we mean ensuring that everyone understands who has: Accountability, to make sure a decision happens; Responsibility for doing the work; those who must be Consulted before decisions can be taken and finally those that must be Informed when a decision has been taken.
There have been many years of industry practice and often internal experience to agree how the typical external supply decisions are made and captured. Serialisation is an area where everyone is learning as they go along and therefore, there is no commonly understood ‘playbook’.
Decisions associated with a serialisation integration will fall in to a number of areas, including:
- Relationship and contractual
- Serialisation design
- Quality and validation
- Implementation timing and coordination
In the third and final part of this blog series I will look at the final six learnings from our experience of working with CMOs, relating to your internal teams, template models and protocols, programme management and preparing for future change.
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