The media coverage of increasing incidents of theft, counterfeiting and adulteration have challenged the level of confidence patients have in the integrity of their pharmaceutical and Life Science products. The public perception is putting increasing pressure on regulators to put into place regulations that require tighter controls on packaging and distribution chains to ensure the integrity of the products delivered to patients. Is this enough to make serialization a reality across the industry? And if it is, are companies truly ready to implement a robust serialization solution? Serialization has been a hot topic in industry forums lately. Nothing new there.
Serialization has had several moments in the spotlight over the years since the initial ePedigree legislation in California. We saw the excitement then fizzle as legislation was pushed out and economic pressures challenged non-critical capital investment. However, this time the tone is a little different, as the industry is starting to see that serialization, in some form, will be a reality and it is no longer a matter of if, but a matter of when serialization will be a requirement. The challenges in this new reality for companies are where to make the investment now, considering the regulations within the U.S. and abroad are not unified or complete. Starting with what the industry does know as part of their strategies and initiating pilots would be a wise investment.
What Does the Industry Know Aabout Serialization So Far?
- Packaging configurations: Physical space will be required for serial numbers on the product package or label.
- Packaging operations: The degree of automation and serialization-readiness of packaging operations must be a consideration in setting the timing for a serialization initiative. Also, changes to the operations to incorporate new steps and line of sight barcode reading may be required.
- Information systems and software: Beyond allocating and applying serial number data on the packaging line itself, capabilities for generating and managing serial numbers are needed for packaging operations. Other considerations include capabilities for associating the serialized data to cases and pallets, transferring of data along the value chain, and integrating serial number data with order management and pedigree information.
- Business processes and methods: New business processes and policies will need to be developed for defining serial numbers, allocating them across multiple packaging operations and lines, and dealing with data-driven exceptions and failures.
Serialization alone is not enough, but combined with other techniques, such as tamper-proofing, overt/covert markings, and physical security features, serialization can offer companies a comprehensive approach to addressing the security and integrity of their products.