Serialization Implementing Serialization Solutions: Key Challenges and Lessons Learned
With serialization deadlines approaching, the pharmaceutical industry is facing unprecedented challenges. Manufacturers and CMOs are called to action, while competitive opportunities arise from a new approach to supply chain management.
The global framework of patient safety policies, which are being implemented by governments worldwide in order to fight counterfeits and frauds has created an unprecedented push for the life science industries to update their manufacturing processes. The challenges are focused on item serialization and in general product tracking and traceability throughout the supply chain.
1. Serialization and track & trace — shortly to be enacted with the EU-FMD all across the European Union — represent by far the biggest challenge the pharmaceutical packaging industry is experiencing today. Manufacturers and contract packagers have the difficult task of fully complying to regulations, while keeping control on costs and minimizing validation efforts. Based on experiences with large and small pharmaceutical companies worldwide Antares Vision, provider of serialization-based traceability for the pharmaceutical industry, has developed a comprehensive hardware and software solution capable of managing track & trace at all levels. Company has collected a number of key challenges and lessons learned that can benefit anyone approaching the start of their serialization project.
Serialization affects every aspect of the pharmaceutical business: proper implementation uses up resources and the impact on an organization should be fully assessed. Not only regulatory offices, supply chain management, engineering and IT systems, but also project management, operations, quality, internal training, packaging and artwork/marketing departments are involved in the process. The creation of a dedicated working group with representatives from all these different areas has proven successful in the deployment phase.
2. When evaluating new hardware to be implemented, the choice between new stand-alone serialization modules and integration on existing machines is another crucial issue. Ready-to-go modules ensure lower line downtimes and less validation efforts, together with higher efficiency. The possibility to integrate additional functions such as checkweighing, tamper evident and labelling on these units may save overall space on the line. On the other hand, integration kits that print and verify serialized data mounted on existing equipment may be the solution when space constraints do not allow for other options.
3. Serialization is introducing a paradigmatic change in the shopfloor: every carton is not the same as any other, since they are no more interchangeable. A key factor in this new scenario is the ease of use of the serialization system. Operators and supervisors will have to deal with new procedures and few, clear “buttons” on the screen must enable the start/end and managing of serialized production. To reduce downtimes and the risk of entry errors, product changeover can be managed through centralized storage of “recipes”.
Within the Antares Tracking System, when the START production button is pressed, all the parameters (serials, master data, devices configurations) are automatically retrieved from the central database and sent to the devices to enable operation.
4. The manufacturing process must be working “at its best” to minimize the loss of OEE — Overall Equipment Effectiveness — expected with the introduction of serialization. A line not perfectly operating will reduce OEE due to the reworking required, that is higher with serialized production. This is why accurate OEE measurement must be put in place prior to implementing serialization.
5. Interfacing with existing ERPs, MES and other applications is critical and complex. A comprehensive software architecture such as the Antares Tracking System provides a single point of connection to the ERP and Level 4 (EPCIS systems) and a single source of serial data management, eliminating duplication risks. At the same time, it allows the central management of recipes for all vision systems and printers operating throughout the plant, central data backups and efficiency in upgrade and validation strategy.
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