Pharmaceuticals companies are moving quickly to meet fast-approaching serialization compliance deadlines, with approximately 90% of prescribed medications worldwide expected to be serialized by 2020. This requires that they coordinate efforts with contract manufacturing organizations (CMOs), which have, over time, become an important component in the pharma manufacturing ecosystem. In fact, CMOs are expected to generate $79.24 billion in revenue by 2019. Given this codependency, pharmaceuticals companies need to collaborate closely with their CMO partners on serialization to avoid compliance-related supply chain disruptions.
Pharma companies are in various stages of implementing serialization across their supply chain to meet emerging regulatory mandates. As regulations across the globe are still evolving, a standard approach to serialization with well-established ways of working is still in progress. Our experience with CMO serialization has shown that pharma organizations need a structured, proactive and strategic approach covering all phases of program implementation to ensure successful CMO collaboration.
The following four-phase framework is structured, sequential and logical to ensure successful CMO serialization collaboration. The framework’s execution approach has four distinct phases covering the CMO serialization journey, geared toward two primary objectives: ensuring product supply (no supply disruptions) and regulatory compliance (see Figure 1).