It is estimated that Pharmaceutical companies across the globe face billions of dollars worth of losses annually because of stolen or counterfeit products. One of the measures the industry took to overcome this challenge was to implement serialization to protect the consumers; which in turn made it more difficult to manufacture fake goods. Serializing a product is only the first step to strengthening the supply chain. Track and trace involves putting in place measures to identify the product and see it’s journey within the entire supply chain in order to reduce counterfeit and stolen products.
With pharma serialization, each product is assigned a unique identifier (UID). As the laws are different in each country, the regulations are defined on this basis. In certain countries the entire product dose may need to be serialized while for some countries the regulations may include even the smallest commercialized or manufactured unit in its regulations. Often manufacturers have set requirements to follow, unlike the requirements in place for companies that are based on the country they’re selling their products in. For example, if a company is based in United Kingdom and sells it’s products in China, Saudi Arabia and India, the regulatory requirements will be different in each country.
The track and trace process is even beneficial to companies as early as from the stages of production, distribution and when it reaches the end-user. Companies enter all the necessary information (i.e. unit details, location, distributor, etc.) for the products into the systems so it’s easier to identify where they are in the supply chain. If needed, track and trace can easily help recall of products making it more cost effective to withdraw a certain compromised batch instead of an entire shipment/unit.
As Track and trace regulations vary on the country’s laws, all products must first be serialized so they’re easily identifiable within the supply chain. Some of the additional requirements could also include reporting of the data to the respective governments and regulating bodies, verification of the products where the product’s serialized number can be cross checked with other data to ensure it’s an authentic product. Serialization requirements also need to take into account:
- The generation and format of the serialized numbers,
- Aggregation of goods that can allow quick and easy scanning of products with their ‘parent vs child’ bundles,
- The guidelines to follow for packaging levels (primary, secondary and tertiary).
To simply put the difference between serialization and track and trace; serialization is when a unique serial number is assigned to each saleable unit of a product which can help in identifying the information of a product’s origin, batch number and expiration date. Track and trace in pharma is the process of the product’s current and past locations. It tracks the journey of the product within the supply chain.