Looking Beyond the Deadline
The Falsified Medicines Directive (FMD) came into effect on Saturday 9th February 2019, with the aim of enhancing the security of manufacturing and delivering medicines released to the European market. To this end, pharmaceutical manufacturers are now obligated to implement specific measures across packaging lines in order to comply with new data and reporting requirements.
Companies also need to consider their data storage and transfer capabilities, staff training, and time to fully trial and test solutions to minimize disruption to supply.
However, including these safety features on pharmaceutical products requires fully integrated packaging lines involving heavy upfront investments and a lengthy implementation process. Among many operational challenges, pharmaceutical companies have had to sufficiently test solutions in order to avoid drug supply disruption following the enforcement date.
Erik Haeffler, Vice-President of Manufacturing Services and Head of CSR, at Recipharm spoke with PharmTech Europe, about the software and safety features that pharmaceutical manufacturers are now required to meet to ensure FMD compliance. He also discusses the potential impact of untested solutions and capabilities on supply volumes.
For the full article see here: http://www.pharmtech.com/looking-beyond-deadline