Serialization of the pharmaceutical product and anti-counterfeiting technologies

New regulations, updates and developments for the Life Science industry: topics on the agenda of the AFI conference and the direct testimonies of some suppliers of technology for the Track & Trace, which will be on show at the coming edition of Pharmintech.

Among the innovations of greatest impact for the companies of the sector, the serialization of pharmaceutical products and the new perspectives opened by the entry into force of the European legislation, which regulates the traceability process along with initiatives to counter the circulation of counterfeit medicines.
In the European Union the serialization of prescription pharmaceutical products will be mandatory from 09 February 2019 according to Directive (EU) 2016/161. The US Drug Supply Chain Security Act (DSCSA) made serialization mandatory at the end of 2018 and requires that seamless Track & Trace procedures be implemented by 2023.
In other large markets such as China, Turkey and Brazil, implementation has already taken place or will soon be launched. Exporters to these countries must already be in compliance with the required regulations.
Hence more than 40 countries have promulgated, or are about to promulgate, laws designed to ensure the traceability of pharmaceutical products along the supply chain, with the aim of providing a higher standard of security and monitoring.
On the other hand, the technological revolution under way in the pharmaceutical system - the so-called Life Science 4.0 - is far superior to the digitization of other manufacturing sectors of  Italian industry and allows greater connectivity between physical and digital systems, thanks to data management collected during production.
 
Testimonies for 4.0
And if the best practices illustrated by AFI (see box), are supported by the reality of Pharmintech, comprising the excellence of international leading companies  from the Track & Trace sector, one has a global vision of new technologies and Smart Manufacturing and Automation solutions.
As stated by Emidio Zorzella, CEO Antares Vision «Today almost all pharmaceutical companies are equipped with serialization solutions that meet the directive.
The last phase is linked to logistics, which sees the implementation of decommissioning systems. But the new challenge is “beyond”: the next step is to use the data generated by serialization for efficient production management, monitoring performance, managing critical issues and maximizing OEE (Overall Equipment Effectiveness) indicators. Moreover, using modern machine learning technologies, ones own systems can be implemented with an optimized planning of activities: these are customizable solutions based on the specific needs of each production, which do not affect the validation procedures and the performance of existing systems».
• «All our cartoning, labeling or end-of-line machines are prepared for the integration of any Track & Trace (T&T) system» the IMA managers declare. «Our goal is to facilitate customers, adapting to their preferences, their orientation or solutions already implemented, re-proposing the same approach even in the case of the supply of new complete lines. IMA has adopted a very flexible policy regarding the installation of cameras and related software: depending on the type of tamper-proof packing adopted by the customer, we can install the T&T unit on both the cartoning machine and on the labeler».
 
• Romaco will be bringing highly automated solutions to Pharmintech, capable of providing reproducible parameters and high quality end products; solutions designed for Track & Trace technologies which, by connecting to serialization software, allow the identification and tracking of cartons: in practice, aggregation and serialization solutions are implemented.
 
• As reported by Alberto Negri, Director of Marketing & Sales at SEA Vision, that has entered into the orbit of the Marchesini Group: «According to estimates by Farmindustria, thanks to the farsighted investment policy of many companies, technology spending has reached 6.5 billion euros in recent years.
But if the pharmaceutical industry has been able to align itself in time to the change in the sector’s global regulatory compliance perspective, it is slow to embrace the transition to Pharma 4.0, despite the fact that it has been widely developed. For our part, as of today, 80% of the machines equipped with a SEA Vision vision system can be easily integrated in 4.0 mode.
We have developed an ad hoc solution that implies a simple upgrade of existing systems, which would allow us to implement data analysis and visualization functions that would open great scenarios to companies, to optimize productivity and intra-system communication, without subjecting oneself to unnecessary increases in costs, time and resources».

AFI: a convention on best practices
Scheduled at Pharmintech 2019 (April 12, Sala PLENARIA, Hall 21), the conference proposed by AFI - the Pharmaceutical Industry Association will have as its object the serialization of pharmaceutical products.
The event will offer an overview that ranges from the presentation of the first data, relating to the number of companies that have registered at the EMVO - European Medicines Verification Organization, to then move on to the assessment of the state of implementation in the various European countries with the institution of national databases, the NMVOs - National Medicine Verification Organizations.
There will also be case histories dedicated to the launch of the serialization process at selected pharmaceutical companies and the updating of the AFI on the date of implementation of the legislation in Italy, with the analysis of the impact of serialization on the entire supply chain.