In the pharmaceutical industry, track and trace serialization plays a vital role for getting medicines from the manufacturer’s facility, to the distributor, to the hospital or pharmacy.
And when American doctors, nurses and pharmacists ordered or prescribed an astonishing 271.4 million prescription drugs during emergency room visits alone throughout 2010, the need for properly identifying and labeling of these medicines is clear.
In addition, by the year 2010, counterfeit pharmaceutical products cost the pharmaceutical industry $75 billion in lost sales. To ensure your pharmaceuticals are properly identified and tracked throughout every step of the distribution process, and that you prevent the spread of counterfeit or misbranded drugs, the proper implementation of pharma serialization is crucial.
Not sure how to successfully establish track and trace pharmaceutical serialization at your manufacturing company? Here are the three best practices to keep in mind as you work toward full pharma serialization architecture:
Opt for centralization over regionalization
In all cases, serialization should be carried out from a central corporate location which then spreads out to local, regional sites — not the other way around. This will help ensure uniform implementation of your serialization architecture, and allows you to be certain that all regulations will be followed. Serial numbers should be generated in a central repository, then passed down the supply chain.
Use the four-level structure
There are two main structures for serialization architecture: four-level and three-level. In the ANSI/ISA-95 four-level structure — device, line, site, enterprise — is ideal because it improves system security, maintains data integrity and helps reduce change costs. The three-level solution, which removes the “site” part, is more prone to costly mishaps and security issues.
Consider the role of vendor selection
Generally, you should limit the number of vendors at each level in the serialization architecture, but especially at levels two and three: line and site. By keeping the number of vendors to a small handful, you can greatly reduce the number of potential failure points in your architecture and promote accountability.
Have any other tips and advice on successfully implementing track and trace pharma architecture? Share with us and your fellow readers by leaving a comment below.