The military, aviation, nuclear, and transportation industries have transformed their safety records by using a
systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system
using available literature including academic publications, policies, and guidelines established by regulatory bodies and
drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of
pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address
known problems within the system, and provides a means to conduct proactive risk analyses, which would create
significant pharmaceutical safety advancement.
Keywords: Healthcare, industry, manufacturing, pharmaceutical, supply chain, system safety.
Rights & PermissionsPrintExport