By Yvonne Sargent, packaging and serialization consultant, ESP (Enterprise System Partners)
By now you probably know that serialization is your best option for combatting counterfeit pharmaceuticals. Unfortunately, you probably also understand that developing and implementing a serialization plan is no simple task. Your packaging, warehousing, and supply chain processes all will be altered, which involves a lot of change management for any organization. The primary goal, of course, is safe and secure drugs for patients, and yes, regulatory compliance is part of the equation. But many people underestimate the additional positive effect serialization can have on a company’s brand.
DISCOVER PACKAGING ERRORS EARLY
Serialization can significantly reduce the risk of product recalls by making it more likely that you will uncover a packaging/printing error while the product is still under your control. For example, packaging errors are typically related to component artwork, the printing of variable data (e.g., lot number, expiry date, manufacturing dates), and component quality (carton and ink), which affect the legibility of the code as it moves through the supply chain.
Typically when introducing a serialization program, there will be an increased focus on in-process checks at a packaging level, ensuring that defect levels are reduced. When validating the printing and vision equipment associated with serialization, you likely will be faced with challenges related to print quality, readability/legibility, testing of 2D code quality, and similarity testing — where the vision system is challenged to detect between similar numbers and letters (e.g., 6 and 8; 8 and 9; a, c, and o; f and t).
If a product does have to be recalled, with a serialized system in place, you will be able to respond more quickly. Doing so not only helps protect the patient, it demonstrates to regulators the control you have over your supply chain and quality management system procedures, and ultimately it limits the damage to your company’s reputation.
THE BENEFITS OF SERIALIZATION ON YOUR SUPPLY CHAIN
The following are some of the benefits serialization offers to your supply chain:
- Improved visibility of products as they move through the supply chain will consequently reduce product shrinkages and losses.
- Your expiration date-management system will become more efficient. Regular stock controls such as cycle counts can be performed with greater efficiency by using system-generated data. That data can be reviewed with greater ease and at a frequency that suits the business, thus minimizing stock write-offs. (Traditionally this may have been performed by manually counting stock.)
- While serialization will not provide companies with any specific sales data, as the product moves through the supply chain and touches various points (e.g., distributors, 3PLs, warehouses, pharmacies), greater visibility of product movements will become apparent, which enables smarter sales forecasting.
- Serialization will greatly reduce — and maybe even eliminate — product diversion incidents whereby genuine product is fraudulently diverted to be sold in a different market than it was intended.
- You will experience improved inventory management of both finished goods and consumables (e.g., inks, wrapping materials, cardboard, pallets).
PLAN AHEAD WITH YOUR TEAM
There are several teams that should be considered part of any serialization plan. At a site and packaging level, personnel from supply chain, production, automation, engineering, IT, quality, and regulatory affairs will all be impacted by the introduction of serialization. Before implementing your serialization strategy, talk with the employees in these departments, and seek to understand their perspectives on how their jobs may be affected or what suggestions they may have for process improvements. And keep that dialogue going throughout the implementation process.
The greater automation and data management associated with serialization equipment allows companies to use this information to save time on line changeovers as opposed to having to perform manual counts. Many companies have utilized this additional focus on their packaging function to implement 5S and other lean tools, as it provides an opportunity to take a holistic view of your production area and implement improvements.