David DeJean, VP, Center of Excellence, Systech International, was the presenter for this Pharma EXPO discussion on best practices in implementing serialization. He emphasized that while serialization is a good first step in helping brand owners to recognize their own products in the supply chain, the possibility for many errors still exists, especially with serialization systems that are not fully integrated across multiple global sites.
DeJean began by pointing out key architectural and organizational questions that all manufacturers should consider when building their programs, including:
• Organizational approach to serialization
• Serial number management
• Managing equipment and software
• Vendor selection
He then presented the solution choices in terms of best practices his firm has identified in working with clients.
1. Organizational approach to serialization: should it be centralized or regionalized? DeJean has concluded that serialization implementation should be led from the corporate center, with inclusion of regional and local site needs. Benefits include standardization, better production planning, risk management, and stakeholder inclusion.
2. Serial number management: should it be centralized or decentralized? DeJean stated that in his opinion, serial number management should be centralized, with numbers generated in a core repository and passed down to production sites and their respective lines.
3. What major architectural elements should a serialization solution contain? Many companies follow the ANSI/ISA-95 four-level solution (www.ANSI.org), which creates a four-level stack (device, line, site, enterprise) model for developing an automated interface between enterprise and control systems. The alternative three-level stack architecture advocates a connection directly from the line to the enterprise. DeJean supports a four-level stack in that it reduces change costs, boosts system security and resilience, and promotes data integrity.
4. What is the best approach for managing equipment and software vendors? Should companies search for a turnkey vendor, one that can provide both packaging equipment and software, or should there be separation of software and hardware purchases? DeJean advised attendees to separate those purchases, and focus on procuring best-in-class equipment and software for their serialization solutions. Aligning procurement strategy across the enterprise, he continued, means manufacturers can obtain the benefits of both approaches without the downside risks.
5. What role does vendor selection play when building a serialization program? DeJean’s best-practices recommendations for this section break down into three parts:
• Limit number of vendors, especially those providers involved in the architecture at levels two and three (line and site). Doing this should reduce the number of potential failure points in the architecture, promote a single point of accountability, and reduce change costs.
• Choose the flexible solution. Preference should be given to a vendor that utilizes configurable rather than customizable software, allowing pharmaceutical manufacturers to rapidly adjust infrastructure for new regulatory requirements, and, again, control change costs.
• Choose the scalable solution. A key requirement of leading serialization vendors is international coverage. This capability offers manufacturers consistent solution standards across their global infrastructure, local knowledge and support, and the potential for cost savings.