Erik Haeffler 
Vice president manufacturing services and head of CSR, Recipharm

Abstract

As serialisation deadlines draw closer, contract development and manufacturing organisations (CDMOs) must recognise the vital role they play in ensuring industry-wide compliance. Many sponsors outsource to multiple contract manufacturers, that must all meet the new compliance requirements to ensure continuity of supply. In this article current levels of preparedness for the European Falsified Medicines Directive (FMD) are explored and some key considerations when looking for a contract partner are discussed.

THE TASK AT HAND

Serialisation and track-and-trace regulations have been an industry hot topic for some time now and with the FMD deadline on the horizon, pharmaceutical companies should be turning their attention to ensuring compliance. However, with many having delayed their preparations, it is likely that a number of companies will be unable to implement a tried and tested solution internally, on time.  

Consequently, outsourcing serialisation requirements is becoming an increasingly popular alternative, particularly if companies need to meet the regulations of multiple markets. The potential impact of being unprepared for serialisation is huge. Failing to meet the regulatory deadlines will inevitably lead to costly downtime, supply shortages and even a loss of business in key markets, making serialisation compliance crucial to continued business success.

NAVIGATING THE COMPLEXITIES

The serialisation landscape is a complex one. Pharmaceutical companies and their CDMOs often use multiple lines to supply product to multiple markets. For example, our company has around 250 customers that will requ ...