Staffan Widengren, Director of Corporate Projects at Recipharm, spoke to Manufacturing Chemist on the challenges CDMOs face to be ready for the FMD deadline in February 2019. Widengren will be speaking on this topic at FutureLink Munich, 6-7 June, for more information see: https://www.tracelink.com/futurelink
With the Falsified Medicines Directive (FMD) deadline in February 2019 drawing closer, many CDMOs will be faced with an organisational upheaval in preparation for the new regulation. In addition to this, securing adequate finance for serialisation will present a challenge, particularly in the case of smaller CDMOs for whom acquiring new equipment and introducing new systems may prove problematic. With such a long route to complete serialisation, and the upcoming deadline, CDMOs must prioritise their focus in order to efficiently achieve compliance.
CDMOs should aim to have finished testing and validating their solution at least 3 months before the FMD deadline in February.