A cGDP Primer: New Distribution Models For Life Science Supply Chains
The life sciences industry has undergone many changes over the last decade, with consolidation, mergers, and acquisitions across both small and large pharmaceutical and biotech companies. One result of these changes is complex supply chain models, with a combination of in-house and outsourced research, product development, and commercial operations. The level of complexity has presented challenges for stakeholders and their supply chain partners: suppliers of materials, components, and packaging, as well as contract research (CRO), contract manufacturing (CMO), and logistics service providers.
Networks of storage facilities are connected by a variety of transportation modes, across extended geopolitical regions. It is no longer sufficient to manage supply chain quality and compliance activities in a relatively controlled environment “inside the box.” Ensuring the quality, safety, and efficacy of API, raw materials, ingredients, and related packaging components requires oversight and compliance across the many links in the chain — the dynamic environment of global distribution. Risk factors abound, not the least of which is an increase in diversion, counterfeit, and corruption of the legitimate life sciences supply chain.
Global regulatory bodies have responded to these challenges, requiring digital audit trails in the form of mass-serialization — e-pedigree and formalized track and trace programs. Further complicating matters is the recent increase in oversight by industry groups and regulators, enforcing guidelines for establishing, monitoring, and controlling storage and distribution operations.
Source: Pharmaceutical Online