Serialization and Packaging – New Requirements for Pharma Industry
Concerns for drug integrity are rising and at the moment, over 40 countries have introduced track-and-trace laws in order to follow the product through the supply chain. It is expected that by 2019, these laws will apply to 75% of the world’s prescription medications. Requirements are different depending on a country, but they all rely on one key aspect: Serialization.
Serialization means assigning unique, traceable numbers to each individual saleable unit and though it sounds pretty simple, implementing serialization is a complex process.
Producing identical units to an exacting standard is no longer a manufacturer’s main concern. After production, each item has to be identified with unique data which needs to be further communicated to supply chain partners. Manufacturers are also accountable for that data for a certain period of time, which may last for several years.
Serialization requires upgraded packaging lines, and in order to upgrade your packaging line, you need to answer a few questions and precisely define your needs.
Equipment. You will need to determine new equipment needs. Are your current printers able to produce the required 2-D barcodes? Are your vision systems ready for the challenge?
Downtime. Upgrading lines leads to downtime. How long will each upgrade take? Can you adjust production schedules in order to have enough products in stock while your machine is being upgraded?
Artwork. Changes in design do not affect the packaging process directly, but they shouldn’t be overlooked. Many pharmaceutical companies have to change their labels to ensure there is enough room for the 2-D barcodes and other human-readable components. How much time will it take for your design team to redesign the label and how much time will it take for FDA to approve your new layout?
From this point of view, implementing serialization seems like quite a hassle. On the other hand, serialization can bring many improvements to your management data rather than just being a law enforced obligation.
- Recall Management
Recalling bad, tainted or spoiled products is a challenge shared by many manufacturing industries. If you do not track the distribution of batches or lots through distribution and retail channels, then you cannot do the recall accurately, causing an expensive 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.
Being in control of your supply chain and tracking the product allows you to alert your stakeholders when things are not going according to plan. The sooner you know something went wrong, the sooner you can fix it and thus reduce costs or errors and anticipate and plan for issues before they happen.
- 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.
- Supply Chain Planning
Unique product codes allow you to always know how many of your products are left, for example, in-store inventory. Inventory visibility helps you to predict when and where to replenish products. It also helps you to asses all sorts of merchandizing issues, from displays to distribution patterns.
As you can see, implementing serialization is a serious endeavor, but the benefits are worth it. All you need is a trusting partner to help you prepare your packaging lines, so that you can respond to these new requirements. Tishma Technologies is a good choice. While you are here, make sure to check Tishma Technologies’ cartoners, tray packers, case packers or palletizers, available with laser and inkjet printers and Serialization vision and tracking capabilities.