As serialization deadlines loom, pharmaceutical manufacturers and their supply chain partners must look for ways to fully track and trace products throughout the supply chain. The need for serialization is in large part a response to the exploding industry of counterfeit drugs, drug adulteration and diversion of drugs to other markets—all things that have been propelled by Internet sales and unsecured global supply chains.
On the road to serialization, companies face three major challenges:
Technology for managing serialization
Pharma companies rely heavily on technology to manage their products, from packaging and labelling through to customer service. Serialization adds another level of complexity to this process, requiring that systems check not just for the presence of physical attributes, but also validation of correct data exchange for the intended market. Serialization technology providers are continuing to evolve in their maturity as more products on the market become serialized and new requirements surface globally.
Lack of alignment around serialization requirements
Although there are global standards for the information that goes on product packaging, each country has its own requirements for what data should appear, how it should be displayed and what data needs to be captured to meet reporting requirements—either to the government or other supply chain partners. Imagine enabling a supply chain to support serialization of products destined for 80 different markets, each with its own unique labelling requirements.
Data exchange and use of information
A further issue is how data is exchanged between pharmaceutical supply chain partners, and who pays to design and build solutions to support the data exchange as well as operate it. Should data be stored in a central database or at each supply chain partner? Should data be pushed or pulled from the database when changes are made? Several different industry initiatives are underway to help address these questions and provide recommendations to government entities. However, there are no clear answers today.
What can supply chain partners do?
In the face of these challenges, supply chain partners need to establish a holistic supply chain security strategy that focuses on both the end-to-end value within the company’s four walls, but also the value for the patient and how they interact with the product (e.g. self-authentication, etc).
A comprehensive and integrated set of strategies that combines existing inventory visibility capabilities with serialization data can:
Increase end-to-end supply chain visibility and reduce time to market
Drive integration and improve data availability and accuracy
Ensure product safety, integrity and authentication
Maximize profit while providing the highest levels of patient services and experiences
Improve access to medicine and reduce counterfeiting
Wherever a company is on their journey to serialization, it’s never too late to think about how serialization technologies and processes, and investments in compliance, can be used to gain more value, see further benefits and drive smarter decision-making.