In a preview of his presentation, Manufacturing Chemist interviewed Staffan Widengren, Director of Corporate Projects at Recipharm on the challenges and priorities for CDMOs in the countdown to the Falsified Medicines Directive deadline.
MC: What has been Recipharm’s biggest challenge when it comes to serialisation?
Widengren: Recipharm’s challenges are indicative of the wider CDMO sector. Securing the initial approval for the required investment was one of the toughest jobs, Recipharm’s serialisation capex will come to €40 million. Securing an investment of this scale, which may not create additional value beyond regulatory compliance for the project is a demanding process – for smaller businesses with less resources, this can be exponentially more difficult.
Aligning all Recipharm’s 15 sites with a central enterprise solution was the business’ next major challenge. A central system means coordinating business processes, global compliance requirements, intra-organisational connectivity and system interfaces, reporting protocols and data management practices across multiple sites around the world.
Finally, the on-boarding of some customers has presented major difficulties. Recipharm, has successfully on-boarded more than 70 customers to date, with another circa 130 to go.
The biggest challenge comes from customers that are not using the same network-tenant approach Recipharm is using in partnership with TraceLink – setting up point-to-point connections has taken more than a year in some instances, instead of a few months. To better manage the complexity and scale of on-boarding, Recipharm adopted a standardised approach advocated by its serialisation partner, TraceLink, to onboarding:
- customer invitation
- creation of product master data sheets for each product
- educational call with all stakeholders
- system set-up
- end to end test
- internal data verification test with real product and serial numbers.
MC: What are the greatest barriers to pharma businesses achieving compliance at this stage?
Widengren:
The barriers to achieving compliance for pharma businesses are numerous, but there are a few common threads. Firstly, the level of investment and resources required is significant, for smaller businesses it is prohibitive to the point of being unfeasible.Secondly, there is a lack of knowledge about serialisation, which has led to many businesses failing to anticipate the complexity of implementing a solution. Plenty of businesses have delayed their projects too much as they failed to appreciate the scope of the work.
Several third-party specialists can fill in knowledge gaps, however, they are in high demand and early movers have in many cases secured priority status.
MC: Is there an ideal timescale that CDMOs should work to?
Widengren: Ideally, CDMOs should aim to have finished testing and validating their solution at least 3 months before the FMD deadline in February next year. Customers, especially those with high volumes, will want product stocked before the deadline.
This 3 month window also provides plenty of leeway for any fixes or additional testing and validation required.
MC: What should CDMOs be focusing on in the next year?
Widengren: For CDMOs just starting their serialisation, it’s very late and they will be increasing risk if they look beyond using standardised equipment and validated solutions. Vendor availability is limited at best and customisation is not going to be an option.
Late starters would also be well advised to explore joint ventures wherever possible - most CDMOs are not packagers and they could feasibly partner with better prepared CPOs to deliver serialisation.
Businesses must prioritise compliance, there’s a lot of discussion around adding value to serialisation programmes, but this can and should wait until a system has been implemented, partners on-boarded and the entire process validated. The on-boarding process is complicated as most customers are at different phases of their serialisation project and it’s not just a matter of negotiating connection process – there are financial elements to be negotiated and agreed.
CDMOs should also be preparing for aggregation or ensuring their serialisation solution has the flexibility to accommodate it in the future. While aggregation is not mandated by FMD, many in the supply chain are asking it of their partners as they either; want the capability to ship to prospective markets where it is a requirement or have a supply chain, which can realise some of the benefits it offers.
MC: How is FMD likely to shape the CDMO landscape in the near to mid-term?
Widengren: In the foreseeable future, there will be CDMOs that move away from packaging altogether, some do not have the resources to implement a serialisation solution and will look to form joint ventures with CPOs to fulfil their clients’ requirements.
Larger CDMOs with multiple sites may look to develop centres of excellence where serialisation will take place.