When it comes to the EU FMD regulations, Ettore Cucchetti, Chief Executive Officer of ACG Inspection Systems, considers that the key European players readied themselves for compliance during 2019.
However, he believes that other smaller organisations continue to work towards implementation, and that as we move into the new year, the industry is not yet ready for serialisation.
He comments: "I believe that many pharmaceutical companies will not be able to complete the EU FMD regulations before the deadline. Multiple organisations are yet to finalise their registration process, particularly line level implementation at plant level."
"The track and trace regulations will continue to pose a real challenge in 2019 for manufacturing companies and solution providers alike. Changing industry dynamics due to global track and trace initiatives and impacts on business will all be vital."
Cucchetti believes that EU FMD implementation has come at a real cost to the industry.
He adds: "Going forward, the impact on production and overall equipment effectiveness will be helpful for measuring the true cost to the industry. The overall data captured throughout the pharma manufacturing process to the supply chain will be used for predictive quality improvement using traceability."
Looking at the industry as whole, Ettore Cucchetti adds: "We believe that 2019 will bring multiple opportunities and challenges for the pharmaceutical industry. Customer awareness, technological advancements and the global track and trace regulations will all be key drivers."
"In our technologically advanced world, we believe there is a need for innovative and effective solutions when it comes to product authentication and supply chain integrity. The real mantra for success is to be future-ready. Industry players will need to anticipate and plan for change(s) — partnering with the right providers for real success."
"When it comes to the technologies impacting the industry, these include blockchain, machine learning, cryptography printing, AI and Industry 4.0. Increasing consumer empowerment and safety will be vital. Each manufacturer should seek to fully evaluate their product from the raw materials, through to the end consumer."
