Contract Pharma: What challenges have you come up against that you think less prepared CMOs and CPOs will face?

Dexter Tjoa, director of corporate strategy, Tjoapack: When it comes to serialization, timing is crucial and is the obvious challenge. There are no shortcuts to compliance and less prepared CMOs and CPOs are now facing an uphill struggle to meet track and trace deadlines. It is vital that they decide to put in the necessary work or engage with well-prepared trading partners who can provide a compliant solution for them.

Michael Unbehaun, manager of engineering projects and serialization team lead, R-Pharm: During the planning and implementation of R-Pharm’s serialization project, we encountered several challenges linked to resourcing and access to expertise. We found that there were gaps in technical and IT knowledge and vendor service availability was poor due to the demand created by time constraints.

We found that there were insufficient process definitions and security across the site, with issues identified in areas from master data management and production planning to regulatory change management and data integrity gaps. When testing and subsequently implementing our solution we found that there were decreases in line efficiency and extended ramp-up phases that had to be taken into account.

These roadblocks all required additional dedicated resources for the project to be a success. Lesser prepared businesses that haven’t built some flex into their serialization budgets would be well advised to do so.

Staffan Widengren, director of corporate projects, Recipharm: One of the biggest challenges we’ve encountered at Recipharm in our preparations for serialization has been the on-boarding of smaller and mid-sized virtual market authority holders and brandowners. There remains a lack of understanding among these companies when it comes to the complexity of connecting with their partner CMOs and the EU-Hub subsequently.

CP: Do you have any thoughts on why CMOs and brand owners are skeptical of each other’s readiness and how this can be resolved?

Tjoa: Industry readiness has been widely discussed and the lack of preparation has been evident, particularly in the FDA’s decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA). It is therefore easy to see why companies throughout the supply chain would be unsure of each other’s levels of preparedness for serialization requirements.

As a general rule, serialization takes an unprecedented amount of cooperation and information sharing between all trading partners and the pharmaceutical industry as a whole is struggling to tackle this task. However, as we move past the initial implementation phase, companies will begin to realise the obvious efficiency benefits to this kind of transparency. As a result, we will inevitably see communication between partners improve.

Unbehaun: Insufficient knowledge of each other’s related organizational and technical procedures can lead to a high-risk project readiness situation between CMOs and marketing authorization holders (MAHs).

To resolve these issues, it is important that the MAH is building up the right level of transparency on project milestones and deadlines together with the CMO. The MAH should be able to specify and monitor the CMO’s progress and level of readiness in relation to single projects steps, including equipment, IT and organizational readiness. For this to be possible, a decision tree with the most important milestones including escalation situations is helpful.

Widengren: Skepticism when it comes to readiness has a number of root causes. There remains a lack of understanding among some MAHs and brand owners as to the complexity of implementing a serialization program.

There’s also a belief, or hope, in some quarters, that the EU will extend the implementation deadline as happened in the U.S. Extending the deadline in the EU would require agreement from all member states as opposed to a singular central government in the U.S. Given that some countries, such as Germany, are very advanced in their preparations, this agreement is very unlikely.