Ensuring serialization effectiveness 3rd May 2018
By Justin Schroeder, Senior Executive Director, Global Marketing & Design at PCI Pharma Services
Justin Schroeder, Senior Executive Director, Global Marketing & Design at PCI Pharma Services, explains the process and benefi
This creates considerable challenges for both pharmaceutical and biotech companies in managing the varying country requirements, and further exacerbated for CMOs who need to manage individual country requirements as well as custom approaches for each of their clients.
There has been considerable debate in the pharmaceutical industry about whether serialization requirements are an effective solution to addressing the threat of counterfeit medicines and grey market activity as well as diversion of medicines. Some companies have embraced serialization as part of their broader global anticounterfeiting strategies to best maintain global supply chain integrity, with serialization being a tenet working in concert with other efforts and initiatives. Others have explicitly stated that they will do enough to meet the most basic serialization requirements and no more than that. These positions are derived from analysis where companies have judged the initiative to be a benefit to their supply chain, and therefore to be embraced, or conversely a burden and therefore minimized. This philosophical difference often cascades out to their operational practices.
The fundamental principle of the serialization initiative is that serialized codes (collectively data), are both secure as well as verifiable. Codes come to the packaging line in the form of a data packet and are both applied to packages and subsequently verified, ultimately commissioned, such that downstream trading partners, prescribers, or consumers can affirm their legitimacy and authenticity. Paramount to this effort is the use of effective technologies for code application.
Just as critical to serialization effectiveness as code application, the process for scanning applied codes is paramount. What is fundamentally different in a Serialized packaging line as compared to a traditional (non-Serialized line) is the fact that each Serialized package, and its code, is now unique and must be accounted for. This demands a sophisticated automated inspection system to affirm the code presence, its legibility and scanability, as well as the process for capturing and commissioning the code. Prior to the implementation of serialization requirements, packaging lines may have been able to get by with manual verification or intermittent in-process testing to confirm the presence of a traditional Lot and Expiration code. With the advent of serialization, and each package being unique, this systematic approach inherently requires electronic data capture and submission to downstream partners. Traditional coding techniques such as embossing/debossing, or older inkjet technologies, do not provide a verifiable presence and resolution to be effectively verified through modern vision inspection for code verification and subsequent commissioning and aggregation activities vital to serialization implementation.
Implementation of this standard – 100% verification and accountability of all Serialized codes – forces packaging systems and controls to be operating with considerable accuracy and rigour, achieved by technology and personnel in concert, through a well-orchestrated systematic approach. The practical experience at PCI in meeting this standard has led us to champion the use of aggregation, and strongly advocating for it at the many industry forums and events we participate. When implemented and executed properly, use of aggregation provides the systematic checks and balances that assure line controls are operating at the highest levels of assurance.
Many companies have viewed serialization as a burden, with substantial investment cost and resource burden for little realized gain. Others have embraced the opportunity it has created, enabling better visibility into the complex supply chain, as well as allowing for upgraded technologies leading to implementation of more advanced practices. At PCI, our own journey has certainly helped us realize more effective line performance through these advanced practices, and provides our customers the highest levels of confidence that their products are secure and compliant in both domestic and emerging markets. The initiative is intended to advance the industry, and if it is embraced, it will certainly do so.