What Your CMO Needs to Know About Serialization and Aggregation
By: Iryne Ng & David Zimmerman, AbbVie Supply Chain Traceability Operations
In recent years, the global pharmaceutical industry has been under intense pressure to enhance the safety, security, and continuity of the supply chain. This has required drug manufacturers and a vast range of supply chain partners to work collaboratively to improve supply chain transparency. The goal is to be able to track, trace, and authenticate products, and to assure prescription drug supply from the manufacturer to the patient.
Serialization lays the foundation for delivering on these objectives by assigning each saleable unit a unique identifier to aid in identifying suspect or illegitimate products within the supply chain. Aggregation takes serialization one step further by building a comprehensive data relationship between the unique identifiers for saleable units, the cases they are packed into, and the pallets on to which they are subsequently loaded and shipped.
Aggregation has become a hot topic as the US FDA nears the November 8th, 2023 deadline, whereby the Drug Supply Chain Security Act (DSCSA) mandates within section 203 that “the transaction information required under this section shall include the product identifier at the package level for each package included in the transaction”1. One of the major challenges of meeting this DSCSA requirement lies in verifying exactly which saleable units are in the sealed cases without having to open each case for inspection. One way of achieving this is to infer that saleable units are aggregated to the cases, whereby scanning each case informs which units are associated with it. A limitation of inference is that it expects aggregation to be perfect, and perhaps over-relies on the accuracy of aggregation data to enable a digital trade model. A second option is to direct scan, requiring that distribution centers open every case, scan each saleable unit, and re-pack the products. This latter approach is highly impractical, not only causing operational issues around labor cost, capacity, and turnaround time, but also impacting quality through damage associated with additional handling.
A further difficulty results from the fact that many other countries have introduced their own requirements for serialization and aggregation since the inception of the US FDA requirement, with distinct variations on data identifiers, data formats and data reporting. Moreover, the generation and aggregation of data at the point of manufacture is only the beginning - systems must be in place at every stage of the supply chain for this data to be accessible and maintained.
Partnering with a CMO that has applied traceability, serialization and aggregation standards across its own operations promises business continuity and speed-to-market that translate to a competitive advantage. AbbVie’s traceability efforts are designed to comply with global regulations, and we adhere to standards from GS1 (a neutral, non-profit organization that develops and maintains global standards for business communication to bring efficiency and transparency to the supply chain*) as well as participating in the Prescription Drug Security Alliance and supporting its efforts to shape and implement processes to comply with guidance and regulations. With robust serialization efforts in place and a long-term strategy to address aggregation, AbbVie is your partner of choice to ensure there are no costly delays in getting your drug to the patients that need it most.
* With the possibility that the global compliance deadline will be impacted by COVID-19, GS1 is maintaining a list of global traceability regulatory updates due to the virus. GS1 members can access this at: https://xchange.gs1.org/cr/Pages/home-new.aspx
Global Compliance Impacts on Supply Chain – Planning Ahead
Complying with global requirements can be extremely complex. With the requirements of existing markets continually evolving, and those of new markets only just beginning to emerge, close monitoring is essential to avoid being unprepared should requirements suddenly become effective. By implementing processes and technologies throughout AbbVie’s entire supply chain to address widespread data variations, AbbVie remains in a strong position to meet worldwide compliance needs.
To illustrate how compliance requirements vary from country to country, it is worth highlighting some of the main differences in data elements and formats. Both the US and EU follow GS1 standards, requiring a product code (PC, such as GTIN or NTIN), serial number, expiration date and lot number to be printed as human readable and encoded in a 2D data matrix. For reimbursement purposes, some countries (e.g. Germany, Spain and Portugal) require an additional data element – the National Healthcare Reimbursement Number (NHRN) - to be printed and encoded.
There are also countries that do not follow GS1 standards. For example, China uses an Electronic Drug Monitoring Code (EDMC) as a unique identifier; this is issued directly by Chinese authorities and is encoded in a linear barcode instead of a GS1 2D data matrix. Finally, there are countries with emerging requirements that are drafted but not yet published; these requirements may remain under development for an extended period before rapidly becoming effective (e.g. Brazil’s requirement has been drafted for years). An up-to-date working awareness of these variations is vital to ensure compliance and uninterrupted drug supplies.
Data reporting is also highly variable. Once generated, data may be shared with governments (e.g. Ministry of Health) and downstream supply chain partners, with many countries requiring data reporting upon product import. The US, however, requires that verifiable data exists at product distribution. Additionally, the EU’s data requirement varies depending not only on the nature of the products (saleable units or samples), but also on the logistics (within EU or EU export), with the exception of article 23 products (e.g. products intended for prisons or the military), which adds further layers of complexities to data reporting. With many drug products destined for multiple markets worldwide, it can be challenging to maintain compliance as data changes hands throughout the supply chain.
Long-Term Aggregation Strategy
Taking control of changes to products and data during product movements is critical to achieve the goal of product authentication and seamless tracking throughout a company's complex supply chain. A robust aggregation process is fundamental to this, strengthening operational practices by creating the right kind of checkpoints and controls, and ensuring that every re-packing, re-palletization, and unexpected event along the route from manufacturer to patient is associated with a change to the aggregation data.
With unrivaled aggregation expertise across multiple manufacturing sites worldwide, AbbVie meets diverse market and operational requirements to ensure data integrity throughout the supply chain. Every one of our packaging lines is serialization ready and will have aggregation capabilities by 2023, with many sites on track to be ready well ahead of the DSCSA deadline. Additionally, by creating our web portal Trace@AbbVie, we already provide our partners with access to the digital supply chain, and electronic data flow for regulatory interoperability.
Using AbbVie Serialization Solutions to leverage data for multiple supply chain activities, we facilitate product flow through improved data visibility. Not only does AbbVie Serialization Solutions perform as an interface for stakeholders, but it can also be used to provision data externally, and respond to external product verification requests such as exchanging master data, commission data, and transaction event data with trading partners for government reporting and external queries.
Aggregation is a topic that will undoubtedly receive growing attention as the DSCSA deadline looms, and rightly so since it is a logical continuation of the FDA and industry’s efforts to secure and strengthen the supply chain. Although some companies are content to wait for mandates on serialization and aggregation, AbbVie has recognized the inevitability of these strategies and has begun looking for providers of these services to stay ahead of the competition. Implementing plans for timely delivery on global aggregation requirements promises to strengthen pipelines and bring essential drugs to the patients that need them most.
For a reliable supply chain partner that is investing in its future, contact us at 1-847-938-8524 or visit www.abbviecontractmfg.com for more details.