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Agnes Shanley is senior editor of Pharmaceutical Technology.
As a special session at Interphex 2015 this week made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.
Track and trace, serialization and e-pedigrees have been topics of great interest in pharma for over 10 years. This week brought reminders that many companies have yet to develop a plan or strategy for taking action on the first step of true traceability: serialization.
The fact is that adding the equipment required for serialization adds complexity to daily operations and the line, says CRB engineer Steve Peterson, PMP, who has worked on a number of recent serialization projects. He recalls one six-month pharma pilot program that gradually morphed into an 18-month behemoth.
The devil is in the details, from things as basic as ensuring sufficient room for printing the authentication data, to incompatibilities between materials. In one project, Peterson recalls, a company tried to print uv code on a top sert, only to find that the black preprinted barcode absorbed the uv ink, and changed signals to the vision system.
As short-term problems and costs creep up, it can be harder to see serialization's ROI. It can also be difficult for managers to see compelling long-term reasons why the technology is so necessary. There can be a tendency to focus on cost-cutting, which often leads to project failure.
At this point, relatively few pharma companies see the reason for developing clear serialization strategies. This is particularly true for contract manufacturing organizations (CMOs), who need to keep operations as simple and flexible as possible, to adjust to the needs of many, varied international clients and projects.
If this situation continues, there is a danger that pharma could return to the situation that existed when the California Boards of Pharmacy first set state deadlines a few years ago. There was a last-minute scramble for help with implementation, insufficient help available, and serious project delays resulted. As Graham Clark, cofounder of TraceLink said, quoting Yogi Berra, “It will be ‘déjà vu all over again’ if more companies do not come up with plans, and strategize with their business partners.
At Interphex 2015, a special session on Serialization on Tuesday, April 21, emphasized a number of points:
· Regulatory deadlines (2017) are already here, and most companies are not ready.
· Most companies drastically underestimate the time required to plan for, and accomplish, implementation
· Most companies are not having any important discussions about serialization and authentication with their partners, particularly contract manufacturing organizations!
· People on the line will need thorough training in order to ensure that systems work as planned. This will be especially important with pre-encoding.
Among the best practices that Peterson suggests are:
1. Engage all internal and external stakeholders, because serialization and authentication efforts will have an impact on every group
2. Develop a program charter and operational strategy as soon as possible
3. Ensure thorough financial support, and avoid the "penny wise but pound foolish" approach. Gaining the support of top management will be critical.
4. Develop strong user requirement specifications
5. Engage validation and operations staff from the start, since their buyin will make or break any project
Consultant Bill Fletcher, who had just returned from a trip to India, where more companies are working on serialization (but not authentication) stressed the need to define user requirements at a general level, and then flesh out the specifics for each individual product, market and line. “Trying to have a generic ‘one size fits all, globally’ solution seldom works,” he said. He discussed the emerging interest in pre-encoding techniques, in which the ID’s are encoded on flat packages before they are filled, which could simplify the process on the line.
Tracelink’s (formerly SupplyScape’s) cofounder Clark, who now oversees CMO and CPO partnerships, said, developing clear agreements with contract partners will be essential.
“The connection between pharma companies and their contract partners is the least well advanced, in terms of discussing a timeline and agreeing upon an approach.” If not addressed soon, he says, it could result in the biggest break in supply chain compliance.
Long term, it could also have a strong impact on the overall business, as service providers that cannot meet client requirements may not be able to remain viable.
Clark did a brief interview on this topic for Pharmaceutical Technology…stay tuned for the video clip, which will appear soon. Bill Fletcher and experts from Systech and OSD Checkweighers also weighed in on the issue.
If you work for a company that is taking pharma's typical conservative “wait and see” approach to developing a serialization strategy, you should move, or try to convince management of the need to move, quickly, to action and implementation.