The global regulatory landscape is continuously evolving to protect patients and ensure supply chain visibility. Companies will need flexible implementation plans and increasingly agile systems to meet varying country and trading partner requirements over the coming years. As companies are planning to meet global serialization and track & trace requirements, there are a range of questions that frequently arise. A few of these questions are highlighted in this report, with strategic guidance for how companies – like yours – are managing these implementations.
What drivers should organizations focus on as they develop their serialization strategy?
For organizations that are just beginning their serialization initiatives, it is important to build initial strategies with a broad view. The main priority of the rollout strategy is to ensure compliance with the current regulations; the second should be to build a flexible plan and serialization solution that anticipates future needs – particularly those that can be addressed without foundational changes. New regulatory requirements and internal initiatives, such as new product launches or site level projects, can be incorporated to allow teams to adapt and adjust program priorities and influence line implementation decisions.
How do you integrate your trading partners, such as Contract Manufacturing Organizations (CMOs), into your rollout strategy?
The manufacturer should ensure open communication with their contract manufacturers before, and as they develop their internal solution and rollout strategy. Determining scope and aligning an implementation with CMOs can be a difficult process, particularly because they are receiving serialization requirements from multiple organizations for one packaging line. Since neither the company nor the CMO can dictate implementation requirements, the two parties should designate key leaders to determine agreeable goals. We’ve found that a single point of contact for each party works best. These two resources should be responsible for setting key milestones, and establishing methods by which they will escalate risks & facilitate issue resolution across organizations.
When a regulation changes or a new regulation is introduced, how should an organization adjust their rollout strategy?
The organization should identify a single point of contact (or contact team) to monitor all serialization regulations, and put a process in place to evaluate the impact to each business unit. Supply Chain, IT, Quality Assurance, Regulatory, Packaging, Operations, Procurement, Legal, and Commercial will need to be included in the assessment. Initially, the responsible point of contact should work with the Supply Chain lead to determine the products, packaging sites and lines affected. Once this analysis is complete, the impacts to the program and timeline can be determined. Discussions with other companies and industry organizations to evaluate legislative interpretations can help organizations fully assess any new requirements.
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