Prescription demand is high; last year, approximately 4 billion prescriptions were filled in retailers in the US alone. As mentioned on the FDA’s website, “[t]he U.S. prescription drug supply is among the safest in the world, but it can be challenging to keep it that way. Criminals – both here and abroad – constantly threaten to replace safe, effective, and high-quality prescription medications with counterfeit, stolen, and otherwise substandard product.”
With this kind of demand and movement in the industry efficacy, security, and safety are crucial to maintain. While falsified medicines are unfortunately a huge global problem, the US’s supply chain of prescription drugs is one of the safest. This can be attributed to various organizations and companies focused on making efficacy, security, and safety a top priority. As a result, safety can be attributed to the supply chain of drug production and the supply chain of drug distribution.
Safety in the Supply chain of drug production
Most pharma companies have global operations, so within the drug production world, consistency, security, quality, and safety are extremely important. Documentation is key in production; it’s important to be able to efficiently track all documentation: certificates of analysis, safety data sheets, packing lists, supplier contacts, and change notifications, etc.
Managing the integrity of the raw materials going into commercial biopharmaceuticals can be extremely challenging, given the uneven supply chain of many of these products. One initiative has been a move away from animal-derived materials used in cell-culture manufacturing to chemically defined media. This move has led to even closer scrutiny of the impurity profiles of other raw materials in order to achieve and produce higher production yields when using alternatives to serum. Increasingly, in fact, manufacturers of biotherapeutics are expecting raw material suppliers to reduce the risks associated with their products, which includes tracing the origins of all of their raw materials back to basic source while carefully managing any and all changes in their supply chains. Much like Carfax reports for automobiles, this tracking and tracing of the supply chain becomes an e-pedigree for the raw materials from its inception.
Safety in the Supply chain of drug distribution
One recent endeavor has been the FDA’s investment in leading a team of global partners to develop and support the Supply Chain Security Toolkit for Medical Products. The goal is to protect the integrity of this complex supply chain by leveraging global resources and developing trainings and best practices for teams to execute. The toolkit focuses on supply chain safety from raw materials to patient use.
Importance of safety throughout the entire drug supply chain
Whether we are referencing safety within drug production or distribution both are equally important in the pharma industry. The focus is a global priority to ensure efficacy, security, and safety in the industry. Work with supply chain partners and subject matter experts to ensure safety within your supply chain.