BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
Meeting the challenges in serialization to win in the battle against counterfeiting
The World Health Organization (WHO) estimates that medicine counterfeiting causes one million deaths a year and that 10% of all drugs sold globally are fake. Events such as Covid-19 increase these risks by disrupting the supply chain and increasing internet purchases.
A key weapon in the battle against counterfeiting is track and trace (T&T), which is the ability to track and trace products through a supply chain – with ‘track’ letting you know where a product is right now, and ‘trace’ letting you know where a product has been before.
The T&T of products through the supply chain is a common health authority requirement but is not globally standardized. Regulations are needed to ensure that systems can determine the authenticity of medicines and improve distribution compliance.
Serialization is the process of defining, assigning and affixing unique serial numbers to product packaging to allow products to be traced through a supply chain. It is critical to the success of T&T. More than ten years after introducing serialization, industry still faces technical challenges and limitations around regulatory expectations, with many pharmaceutical companies still transforming their packaging operations to meet them.
The need for a coordinated T&T approach has never been more important.
BioPhorum’s Serialization – challenges and good practices in packaging operations based on experience of track and trace systems paper is a crucial step towards that goal.
The paper follows a benchmark survey completed by 11 pharmaceutical companies on the serialization of sellable units. It identifies common serialization challenges and broadens the knowledge of good practice and industry capabilities. It also identifies the quickest route to implementing and complying with global serialization requirements.
The four most challenging areas discussed are overall equipment effectiveness and system performance, technical limitations, decommissioning of serial numbers and training. Other areas include governance, grading of print, primary unit serialization and non-standard requirements.
The paper encourages dialogue between industry, regulatory agencies and T&T system providers by adding the unique perspective of secondary packaging customers, summarized after several years of using such serialization systems.
It also contains ‘Key takeaways’ at the end of each section, which list recommended considerations for operators, managers, regulators, and suppliers of T&T systems.
“This paper was written by end-users of serialization and based on real life experience of using the systems”. Ivor Kesic, Continuous Improvement Specialist at Pfizer.
T&T is a crucial defence against the increasing global risks of medicine counterfeiting and fake drugs. This BioPhorum paper will help companies understand, implement and make it a success.