Millions of lives are put at risk every year because of counterfeit products in the pharmaceutical industry. Governments across the globe have set track and trace regulations and enforced serialization of products to identify these faulty goods in the supply chain as a means to fight back.
To ensure manufacturers, wholesalers and 3PLs remain compliant with these regulations; many adapted to investing in new technologies or restructuring their supply chains. However, fake goods continue to flood the markets even more so now, despite strict measures in place for serialization, verification and traceability.
A critical measure that needs to be in place when it comes to combating challenges with serialization is to have a reliable programme. No one solution applies to all so only one supplier will not be able to meet all the requirements; from coding till data handling. That’s why it’s essential to factor in hurdles, roadblocks and successes for greater output and to meet regulatory deadlines. A well thought out plan will factor these challenges and also reduce pressure on budgets and deliverance. Since serialization is global in nature, the correct assessment at the right stage will prevent expensive, unnecessary costs and identify the escalation areas.
One of the biggest challenges teams tend to face is concerning regulatory timelines, reporting and procedures. Multiple iterations take place to an already formulated serialization roadmap structures. Companies must segment, be flexible and act fast for last-minute changes.
Another major issue pharmaceutical manufacturers and their partners face are how to generate, record, verify, share, and report specific pieces of information per shipment. With multiple vendors in place collaborating on various projects, without proper technology in place and the data to support the product history; even end-to-end solutions can become compromised.
Through the L0 to L5 levels, companies and partners can track and trace areas that cause concern in the supply chain and find solutions for commercial shelf products. Generally, it’s believed that most pharma companies seem to lean towards limiting product serialization initiatives to production lines. Such companies lose out on benefiting from the supply chain management benefits through appropriate level solutions (L4/L5).
Since serialization programmes need to work in parallel to another side by side projects, there needs to be a specific allocation of dominions in advance that factor in large scale iterations and additions. Companies must also consider integration and testing of products while setting key targets and milestones in their serialization programme timelines.