Over 40 countries have laid down track-and-trace laws in order to protect drug integrity and trace the product through the supply chain. It is excepcet that by 2019, these laws will affect 75% of the world’s prescription medications. Law requirements vary depending on a country, but they all focus on one key aspect: Serialization.
Implementing serialization might appear simple; it is all about assigning unique numeric codes to each individual product. Yet, there are a lot of details you must pay attention to, before you begin with serialization of your products.
Until now, manufacturer’s main concern was to produce identical units that follow an exact standard. New rules demand that after production, each item is to be identified and marked with unique code which is then further communicated to supply chain partners. Manufacturers are also held responsible for that data for a period of time that may last for several years.
Line Upgrades
Appling serialization requires upgrading your packaging line, and in order to do that, you need to precisely define your requirements and answer a few questions.
Equipment. For start, what are your new equipment needs? Can your current printing equipment produce the required 2-D bar codes? Are your vision systems ready for the challenge?
Downtime. You cannot upgrade a packaging line without certain amount of downtime, depending on how much time each upgrade takes. Try to adjust production schedules to ensure you will have enough products in stock while your machine is being upgraded.
Artwork. Changes in design do not directly affect the packaging process, but they aren’t to be overlooked. Quite a number of pharmaceutical companies have to redesign their labels to ensure there is enough space for the 2-D bar codes and other human-readable components. How much time will it take for your designers to redesign the label and how much time will it take for FDA to approve your new layout?
With all of this in mind, implementing serialization might seem like a real hassle. Yet, be aware that serialization brings many improvements to your management data, so try not to see it as just a law enforced obligation.
1. Recall Management
Recalling bad, tainted or spoiled products is a challenge for any manufacturer. If you don’t track the product through distribution and retail channels, you cannot do the recall accurately which results in costly general recall of all products. Serialization helps you to reduce the impact of a recall, reduce the time to complete the recall and save the brand image.
2. Alerting
The sooner you receive an information that something went wrong, the sooner you can fix it and thus reduce costs or errors and prepare and plan for issues before they occur.
Controlling your supply chain and tracking the product allows you to alert your partners when things are not going as planned.
3. Expiration Management
For products with limited shelf-life, the batch number can be used to determine product’s End-Of-Life (EOL) and help to implement certain management disciplines and strategies. True, this may require certain supply chain partners to capture, monitor, communicate, and act on expiration data, but in the long run it reduces obsolescence, reduces returns, and improves replenishment planning and accuracy.
4. Supply Chain Planning
Unique product codes are helping you to always know how many of your products are left, for example, in the in-store inventory and to predict when and where to replenish the stocks. It also helps you to asses all sorts of merchandizing issues, from displays to distribution patterns.
As a conclusion: Implementing serialization is a serious process, but the benefits are worth it. And thought it seems complicated, all you really need is a trusting partner who will help you to prepare your packaging lines in order to respond to these new requirements. Tishma Technologies is a first choice, so check out Tishma Technologies' cartoners, tray packers, case packers or palletizers, available with laser and ink jet printers and Serialization vision and tracking capabilities.
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