SERIALIZATION UPDATE: COMPLEXITY ESCALATES AS NEW RULES TAKE EFFECT
Years in the making, track-and-trace regulations for pharmaceuticals are being phased in around the world. Compliance is mandatory – but not easy.
Ensuring the integrity of pharmaceutical products has its challenges – consider just a few of them: counterfeit medicines, product mix-ups and “gray market” sales. Product serialization/track and trace systems, backed by government regulations, are one way of tackling these issues. The technology exists; the “will” to act is there. But there’s one problem: Lack of uniformity.
Unfortunately for the pharma industry, as countries race to design and enact serialization regulations, they are doing so independently. This means that, while rules in some markets are somewhat similar – the United States and the European Union, for example – other regulatory approaches vary significantly.
The lack of uniformity can create major headaches for drug manufacturers and their logistics service providers as they seek to learn, interpret and comply with each country’s rules.
The Issue of Aggregation
“Aggregation essentially creates a grandparent-parent-child relationship between the serial number in the product package, the shipping case and the pallet on which it is shipped,” explains Mike Meakin, Vice President Global Quality Regulatory & Compliance at DHL Supply Chain. “Because serialization numbers will be randomized, people want to link those serial numbers to a specific pallet shipment for more complete tracking and tracing.” This means that each ‘generation’ of a packaging hierarchy – i.e. the item, parent multi-pack, shipper case and pallet – is linked.
Some countries require aggregation; others do not – yet.
Three major countries – Brazil, China and Mexico – illustrate the challenges inherent in complying in this new regulatory environment.
Brazil - The Most Complex
According to TraceLink, Inc., a global track and trace network solutions provider specializing in the life sciences supply chain, Brazil has the most complex serialization track and trace regulations in the world today. Under Brazil’s regulations, the registration holder – manufacturer or importer - must track all drug product movement from point of manufacture to point of dispensation to the patient. There are over two dozen events in this supply chain process that must be tracked and reported, according to Brazilian rules.
Additionally, pharma companies must report to the Brazilian Government’s health surveillance organization – ANVISA (Agência Nacional de Vigilância Sanitária) – movement of all drug products into Brazil. They must also provide complete access to their compliance system to ANVISA through a web browser.
China: Systems Challenges
In China, the government sets the rules. Serialization begins with the government. Reporting ends with the government. Therein lie the challenges. China’s regulations require that all levels of product – unit, bundle, case, pallet – must be serialized with a government-issued number, and aggregation is a regulatory mandate. To obtain these numbers, drug manufacturers must run a query on a special Chinese government system. Once the manufacturers initiate and apply these serial numbers, they are then utilized in the packaging lines. After the serial numbers have been assigned, manufacturers must report back to the Chinese government on all on product events.
But reporting is not easy. A number of complications or hurdles get in the way beginning with how reports are entered into the China Food and Drug Administration (CFDA) system. The process is manual. There are stringent requirements as to file size of a report (not to exceed five megabytes), header information, uploading multi-part reports and sequencing them. Additionally, reports must be uploaded by someone actually in China - this cannot be done remotely.
Mexico: Living with a Work in Progress
Mexico is still in the process of fully implementing its serialization regulations, which are overseen by COFEPRIS (the Federal Commission for the Protection against Sanitary Risk). In the absence of fully implemented government rules for pharma track and trace, some companies doing business in Mexico have adopted serialization standards of their own accord or are actively monitoring and preparing. One such company is Pfizer.
Pfizer tailors its serialization programs in countries like Mexico using modular program building blocks and standard operating procedures designed to ensure compliance in a global, cost effective and efficient manner. Having such building blocks developed, tested and available enables the company to adapt quickly to country requirements as they emerge, as in the case of Mexico.
Additionally, Pfizer uses the transition to serialization in countries like Mexico as an opportunity to implement more optimized, systematized processes. The end result, indicates Peggy Staver, Director, Product Integrity at Pfizer, is an improved supply chain.
Benefits Beyond Regulatory Compliance
Compliance to serialization regulations will soon be mandatory around the world, making it just another requirement of doing business. Unquestionably, these regulations will help ensure product security and integrity and patient safety. And as Pfizer has realized, serialization represents an opportunity to improve supply chain operations for a better bottom line.