Erik Haeffler, Vice President of Manufacturing Services and Head of CSR at Recipharm, discusses the DSCSA enforcement delay with Contract Pharma and outlines what companies should be doing now to ensure they are ready ahead of the deadline next year.

The scope of implementing serialisation across packaging lines goes far beyond introducing a barcode. Solutions need to be fully integrated across business operations.

Serialisation has been an industry talking point for quite some time. However, despite this, the DSCSA has taken the decision to delay the date it will actively enforce the new rules until November 2018. Companies are simply not prepared to begin implementing serialisation solutions, nor have they recognised the urgency or the size of the task at hand. The delay offers those who were unprepared a second chance to press on with their preparations.

As part of this industry roundtable, Erik talks about the complex nature of serialisation and takes the opportunity to reinforce that while the delay is a welcome reprieve implementing serialisation remains a time-sensitive task. He also outlines the vital steps that CMOs need to take to be compliant and how experienced contract partners can offer assistance and advice to help streamline the process.

Whilst cost remains a concern for many, the initial investment will also bring long-term benefits and help to avoid hefty fines and supply shortages come 2018. The companies that are well on their way to compliance may see the delay as unfair but they will soon start to reap the benefits of being well-prepared.

Read the full roundtable here:

The DSCSA Delay. What does it mean for the pharma industry?