Today (Monday 27 November) marks the original deadline date for the Drug Supply Chain Security Act (DSCSA). While the US Food and Drug Administration (FDA) has delayed its enforcement of compliance with these serialisation requirements by a year, pharma is still required to legally comply and as such should not sit on its laurels. Here, we feature some comments from industry experts on the DSCSA and the impact a lack of preparedness may have…
Serialisation
Carlos Machado — serialisation director US, SEA Vision
"The original 2017 DSCSA deadline is here. While the FDA has delayed active enforcement by a year, giving many businesses a welcome reprieve, the pharma industry cannot afford to relax. Serialisation is still presenting a serious challenge and must remain a priority over the next year.
"Companies that fail to comply with the regulations risk production downtime and loss of business in key markets. When you consider the potential impact on patients, the current situation is extremely worrying, with many small and mid-sized companies still struggling to meet the requirements. For those that are yet to introduce a solution, it is important that they recognize the enormity of the task still at hand, particularly if a lack of resource has delayed their preparations.
"Importantly, there remains a yet largely unrealised opportunity for businesses to review processes, improve productivity and in some instances, achieve a competitive advantage as part of these regulatory changes. The huge amounts of data that will be generated also creates the potential to increase visibility and information sharing across the supply chain.
"It is also likely that global track and trace requirements will evolve over time. As a result, ensuring that solutions are scalable and flexible to account for this will save resources in the future. In short, a well-considered strategy that plans for mutable requirements and aims to explore and reap the wider efficiency benefits can be a differentiating factor between a good and a great serialisation programme."
Erik Haeffler — vice president of Manufacturing Services, Recipharm
"Today marks the introduction of the Drug Supply Chain Security Act (DSCSA). From now, all pharmaceutical manufacturers are legally required to incorporate a product identifier number on every pack of saleable drug product. Although the FDA has offered a one-year grace period, it can still enforce the regulations at its discretion, meaning companies can still be penalised for failing to comply. In reality, this will probably only happen in cases where something goes wrong, however companies who are not ready to serialise their products today should be working hard to make sure they’re fully compliant come November 2018.
"Moving forward, companies should now be starting to think about the next phases of the DSCSA, which will eventually mean manufacturers will have to introduce three-tier serialisation and aggregation. Implementing a full track & trace system and ensuring a suitable IT infrastructure is in place to support the 2023 mandate is no easy task. Contract manufacturers have a particularly complex challenge to tackle due to the variety of products they manufacture and the breadth of customer requirements. It’s important that companies learn from the mistakes that led to the enforcement delay of the current regulations. A proactive approach is absolutely vital to ensure long term compliance with the regulations."