Staffan Widengren, Director of Corporate Projects at Recipharm recently took part in a Manufacturing Chemist roundtable to discuss the challenge of new serialisation regulations put in place to protect against counterfeit medicines.

A well-prepared CMO will already have made the upfront investment required to implement the necessary hardware, software and cloud systems and as such will be able to spread the cost of serialisation across your supply contract.

The task of serialisation should not be under-estimated and the EU market needs to learn from the mistakes in the US that led to the FDA’s recent decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA). Recognising the importance of contract manufacturers in the supply chain and the need for companies to act now, the roundtable focuses on the role of CMOs in helping pharmaceutical companies to achieve compliance on time. 

The roundtable explores the cases for and against aggregation within the serialisation process, which can add complexities and costs during implementation but also brings a host of benefits, such as the potential to improve overall efficiencies in the supply chain. The participants also consider the wider benefits that track and trace requirements will bring to the industry, as well as making future predictions for the regulatory landscape.

Read the full article here:

The Manufacturing Chemist anticounterfeiting roundtable: part I