Despite the FDA’s decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US until 2018, companies need to continue to press ahead with their preparations for serialisation.

It is vital that CDMOs recognise their level of responsibility as integral parts of the supply chain and understand how their actions could affect successful industry-wide implementation. It is a complex and challenging project for the industry, yet many still do not realise the scale of the task at hand or the complications that could occur during implementation.

Failing to recognise the scope of serialisation could lead to costly downtime and product shortages, as well as potential loss of business in key markets.

In the Medicine Maker’s serialisation focused issue, Erik Haeffler, Vice President of Manufacturing Services at Recipharm outlines the complexities and challenges that serialisation brings for CMOs and the importance of getting ahead in the process. Reflecting on the US deadline extension and expanding on his comments made at NEXUS ‘17, Erik discusses the mistakes currently being made, how to move forward ahead of the fast-approaching deadlines and to what degree serialisation will change the industry.

Read the full article with the Medicine Maker here: What's on the box?