Pharmaceutical companies and businesses often need to track packages through the industry’s supply chain. Companies need to trace their products at an individual and pallet level to ensure that clients receive the right products. Product manufacturing businesses also grapple a lot with supply chain visibility. The pharma supply chains implement product serialization to monitor products efficiently and comply with local legislation.
In the global supply chain scene, serialization involves ascribing unique identifications to each product. Global serialization tracks both the type of goods as well as the individual entity. For pharmaceutical products, each medication box has a different identification product code. Companies can track and trace each package from the manufacturing stage to the consumer stage with the right technology.
Pharmaceutical related legislation often requires that companies serialize their products before introducing them to the market. Specific guidelines and requirements inform how pharmaceutical companies serialize their products. Knowing your country-specific guidelines can save you a lot of trouble once you start the process.
Efficient implementation of product serialization ensures that you meet your legal obligations while securing client retention in some cases. Before we delve deeper into the processes involved, let’s first have an overview of product serialization.
What is product serialization?
Product serialization typically involves assigning unique identities to your saleable product items. Many organizations affix barcodes, serial numbers, or even QR codes to their products as a unique identity. However, you can also use NFC or RFID as a product’s unique code.
Serialization helps you to identify your product item uniquely. Besides, you’ll have an easier time tracking the product’s journey. This process secures your supply chain and helps monitor events such as product loss, delays, etc. Additionally, product serialization minimizes the risk of product diversion.
The top benefits of serialization include:
Secure goods delivery
The most significant benefit of serialization is the ability for companies and businesses to trace their products at the unit and product levels. Besides, pharma companies can also monitor each consignment, especially at the pack level. In this way, your company can flag product quality issues with ease and return missing packs promptly.
Minimizes counterfeits
Companies can enhance their ability to detect counterfeits with serialization. It is common for malicious actors to try to swap goods for inferior products. These rogue players can place themselves at different supply chain stages from production to delivery to the end-user.
Serialization also adds an extra security layer that helps you account for every single box. With more visibility and traceability, the pharma industry can leverage serialization to eliminate counterfeit products.
Regulations compliance
Serialization is also essential for pharma companies looking to maintain compliance with industry regulations. Different global markets have stepped up their stringency while overseeing the pharmacy supply chain. They have taken these steps to enhance patient security and traceability. Companies that implement a robust serialization strategy have an easier time complying with the law.
Companies can get multiple other benefits from product serialization, including:
- Digital re-engagement marketing
- Efficient and quick product recall
- Product performance assessments
- Product demand forecast
Legal requirements and obligations
In the US, the Drug Supply Chain Security Act (DSCSA) specifies the serialization requirement of pharmaceutical products. Major stipulations of the public laws highlight the rules governing product identifiers and product tracing. These laws require manufacturers to include a code with a unique ID, batch number, and expiry date information on each product. Your company can trace the exact location of your shipments at any given time once you serialize your products.
For EU countries, the Falsified Medicines Directive requires all pharma products to have a unique identifier before passing through the region. Besides, your company also needs to upload this information to the European Medicines Verification System. The EU pharma regulations also require companies to monitor their packages as they move through different stages of the distribution chain.
Numerous emerging and mature markets require manufacturers to use a unique serial number to mark each retail unit. Companies can encode the serial number with a two-dimensional code or the linear bar code. Most countries rely on the GS1 and ISO standards to guide the necessary coding and data standards.
Challenge of serialization: is it genuine?
Despite the available value propositions, organizations can have a difficult time implementing their serialization strategies. Most organizations grapple with the cost implications of implementing and maintaining a robust serialization solution. Besides, serialization requires a strong implication of IT and related systems, which is in general very complex and needs steady maintenance. to guarantee the success of this initiative.
With the rise of counterfeits, patients may also have difficulty separating genuine and fake serialized products. Pharmaceutical companies will need to go the extra mile to build confidence among their regular client base. Enabling authentication of serialized products could be an essential step in the bid to boost client confidence. Such initiatives can help clients separate authentic products from counterfeits.
Other potential challenges of serialization include:
- Insufficient experienced personnel and resources
- Inconsistency across vendor technologies
- Risk aversion within a company
- Unclear or unexpected market regulations
- Balancing implementation with competing company initiatives
Combine authentication feature with serialization
Globalization and pervasive technology have fueled the counterfeiting landscape. Pharmaceutical manufacturers require robust solutions to maintain their product’s integrity across the entire supply chain.
Pharmaceutical clients often have to deal with counterfeits that can easily damage a company’s reputation while posing safety concerns to the clients. Implementing a security feature complete with comprehensive product authentication can save your company lots of trouble.
Players in the pharmaceutical industry can implement authentication based on serialization. Essentially, this feature encourages patients to authenticate the products they purchase. The rise in mobility can enhance such solutions as companies get essential information to drive their practices.
Authentication tools are also valuable in capturing product SKUs. Service providers can merge authentication data with prescription data to monitor compliance and send refill reminders proactively. Besides, this technology can create a demand-driven supply chain as it notifies supply entities whenever patients need a product in a particular location.
Pharmaceutical companies can also capture geographic information concerning patient populations and use such information to design disease awareness programs. Ultimately, these companies get to foster active collaboration with healthcare practitioners while creating a sense of partnership.
As the counterfeit industry gains ground, manufacturers can remain ahead of the curve when they assure their audience of authenticity. QR codes on the product tag offer more details to patients and help them build trust with certain pharmaceutical companies.
What do you do with the serialized data? use BMS (Brand monitoring system)
With the serialization process in place, you’ll need effective reporting and monitoring solutions that can help you keep tabs on valuable KPIs. Monitoring data enables your team to track your product usage and analyze the usage patterns. Ultimately, you’ll have an easier time identifying unusual or fraudulent uses.
Data collected from serialized tags gives your company rare insights into the product journey. Given that product serialization helps you identify your products uniquely, you also get to assess your product’s performance with increased accuracy. Depending on the serialization code, your company can trace the whole product journey, culminating in the end-user.
Working with a centralized platform like the Brand Monitoring Systems (BMS) also allows you to centralize valuable product data. The platform lets you personalize the analyses based on your unique business needs. Alternatively, you could use the platform’s intuitive functionalities to collect, prepare, and present product statistics.
Businesses could also integrate the BMS software with SAP systems that combine authentication data with production and tracking information. Analyses of the collected product data will reveal its performance. Brands can also estimate both their supply and sales in specific distribution channels. With this information, you can easily predict product demand and source for raw materials depending on your client’s needs.
Serialized product data will come in handy when verifying product salability and populating medical records. Besides, organizations can also use such data to enhance their recall management and adverse event tracking operations.
Implement a Robust Serialization Solution
Serialized traceability in the pharma industry is essential in boosting patient confidence. Pharmaceutical companies can minimize costs while streamlining processes and enhancing efficiency with a serialization strategy.
The pharmaceutical industry will likely invest more to create serialization capabilities that ease regulatory compliance. A robust BMS system will help your company make the most of data from these initiatives.
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