Most simply, serialization is assigning unique, traceable numbers to each pharmaceutical unit. In detail, it’s a complicated process that has many subsequent effects throughout operations for pharmaceutical companies, contract manufacturers and packaging plants. This requirement is necessary in a pharmaceutical world with lengthy supply chains and international business.
The World Health Organization reports that counterfeit drugs account for 30-40% of drugs in undeveloped nations and up to 1% in the United States. That may seem like a small percentage, but it translates to millions of unregulated, counterfeit drugs flooding the market. “Substandard and falsified drugs are global problems that need global solutions and global collaboration,” said Ilisa Bernstein in an FDA Voice post, “We cannot solve these challenges alone and we at FDA are continually looking for ways to collaborate and learn from our regulatory counterparts around the world.”
A presentation by Johnson & Johnson at the 2015 PDA Annual meeting named specific supply chain challenges that are addressed by serialization. They include medication errors, counterfeiting, traceability, product recalls and managing complex and extended supply chains. Serialization will cause greater visibility throughout supply chains, which will mitigate these issues. Being able to quickly trace products up and down the supply chain, efficiently manage recalls and improve detection of counterfeit products will prove invaluable for pharmaceutical companies.
