Serialization/aggregation regulations are being implemented or are already in place, in many countries around the world. All members of the pharmaceutical supply chain have a responsibility to comply with these regulations in order to prevent counterfeit medicines from reaching patients. Contract development and manufacturing organizations (CDMOs) have their own unique set of challenges to meeting serialization requirements. At Servier CDMO, we began tackling this problem early on, to not only be in compliance, but be positioned to leverage serialization/aggregation technology and data for greater success.
As a global branded pharmaceutical company and CDMO, Servier expects approximately 80% of the markets we serve to have serialization/aggregation regulations in place by 2021. These regulations will do more than require the application of serial numbers to product packaging; they will impact all aspects of the supply chain, including distributors, wholesalers, clinicians, pharmacists, and patients For CDMOs, implementation of serialization/aggregation projects is far from simple, but a complex initiative with numerous aspects that impact many different business pro¬cesses. This requires collaboration across many different units and with external members of the supply chain. When done right, however, there are benefits beyond securing the supply chain—from standardization of equipment and pro¬cesses across facilities to improved qual¬ity, enhanced access to supply chain data and real-time verification of packages in tran¬sit, plus potential cost savings.
Servier elected to take a centralized approach to serialization, establishing a corporate-level team dedicated to this in 2014. The team developed a centralized track and trace so¬lution, with most of the work completed internally, in order to rapidly develop in-house expertise. The program is sponsored by the sup¬ply chain director, but also incorporates representatives from marketing, distribu¬tion, production, finance and more. An organization is in place to maintain the system and work with all aspects of the businesses that are impacted by the serialization program. The system has been developed to be sufficiently versatile to allow for compliance with different country serialization schemes. It also en¬sures full compatibility and connectivity with systems at our CDMO client compa¬nies. The equipment, software and other program components will be the same at all nine Servier packaging plants to en¬sure harmonized operations, and employees at all sites will receive the same training.
Our system addresses the need for both serialization of individual product packages and aggregation of those packages into larger bundles, which are then shipped through the supply chain. Aggregation is necessary to establish the parent-child relationship between a single vial/bottle and the direct packaging (blister pack, carton etc,) it is placed in, as well as at the palette level and beyond − regardless of where the packaging occurs − that are involved in the transport of that single vial/bottle to its final destination. Importantly, it provides real-time information as the product moves through the supply chain.
The investment that Servier is making in serialization and aggregation per line comprises bar-coding equipment, visions systems, software and line control systems. These efforts ensure compliance, as various countryspecific regulations come in to force. The fact that Servier already has packaging lines equipped for serialization and aggregation gives our customers confi¬dence that we have the capability to man¬age all aspects of compliance. In addition, a dedicated quality/validation role within the serialization project ensures that risk assessments of all systems are conducted and all systems are fully audited. Proof of validation and data security are essential for customer reassurance.
Going forward, serializa¬tion will become the new standard for unit traceability in the pharmaceutical industry. Servier recognized this trend early on and responded quickly with the development of a serialization/aggregation designed to ensure compliance around the world. We are gaining access to informa¬tion never previously available to pharma¬ceutical companies, and building capabilities for the manage¬ment, analysis and use of serial number trans¬actional data that will benefit both our business operations and most importantly, our clients.