With the pharmaceutical supply chain becoming longer and more complex than ever, opportunities for counterfeiting, gray marketing or product mix-ups of prescription drugs is at an all-time high. With a series of different regulatory requirements for global compliance, the life sciences industry is in need of a standardized method to ensure and prove end-to-end product integrity. Track and trace capability increases accountability in the pharmaceutical supply chain by directly addressing these issues. This benefits both manufacturers and consumers; yet regulatory mandates have been postponed several times over the years. Why so?
Serialization comes first
In the world of prescription drugs, information of a specific saleable unit is made available as it passes along the distribution channel, from the plant floor where it is manufactured and packaged, right to the point of purchase by the consumer. In order to track a particular unit, it first needs to be marked with Standardized Numeric Identification (SNI) a uniquely serialized identifier.
As I speak more with industry peers, my takeaway is that the lack of standard solutions to support a track and trace system and clarity and global harmonization on regulatory requirements were the main contributors to delays in the mandate. However, today, manufacturers and Contract Packaging Organizations (CPO) are ready. With several serialization solutions available in the market, it seems that the definitive date of 27 November 2017, set by U.S. regulations, for all prescription drugs to be serialized is cast in stone. All new inventories distributed in the U.S. after this due date must contain human-readable information and a data matrix symbol.
Understanding the world of serialization
The information that needs to be printed on the package varies based on each country’s mandate. The U.S., along with most countries, is applying GS1 standards to define the meaning of data elements included in printed bar codes and data matrixes. To be GS1 compliant, each Application Identifier (AI) number listed on the packaging must represent certain information in the correct format – this provides an open standard which can be used and understood by all companies in the supply chain.
In the above example, the four sets of AI represent:
- 01 = Global Trade Item Number (GTIN)
- 10 = Batch/Lot Number
- 17 = Expiry Date
- 21 = Serial Number
Upon scanning the data matrix symbol, the same set of information is decoded.
Manufacturers are required to print the SNI on each saleable unit and depending on the country, each aggregation of units into other packages, such as boxes, cartons or pallets. Once printed each SNI needs to be commissioned, and manufacturers are required to reconcile all the SNIs they have issued with those that are commissioned, remaining, or destroyed. Commissioned SNIs are uploaded to a track and trace repository typically based on EPCIS standards. Europe only requires a “bookend” approach (i.e. authentication of the SNI on a saleable unit), while the US requires retailers to provide an electronic transaction document, authenticating each change of ownership of the product through the supply chain.
With the use of SNIs and aggregation of SNIs for packaging, authorities are able to trace the origin of the package and its shifting ownership across the distribution channel.
Merits of track and trace, enabled by serialization
From the perspective of pharmaceutical companies, serialization of their products secures brand protection and revenue by:
- Preventing product mix-up during the packaging and distribution process
- Stopping products from slipping into the grey market
- Aiding in the product recall process
- Easily identifying counterfeit drugs
It is equally assuring for consumers to know that the prescription drugs they are purchasing are of true origin.
To learn more about the benefits of serialization, download the Life Sciences eBook today.
Serialization takes center stage
Enabling a track and trace system that the world understands is a mammoth task and only achievable when global compliance is adhered to, with all the stakeholders in the entire ecosystem in participation.
It may take several more years for countries to come to harmonized regulations and a common platform where serialization information is exchanged freely and global regulations are enforced. Whatever the case is, formulating a well thought-out serialization project plan should be the start to track and trace success.
Are you considering implementing serialization to enable track and trace? Share your current project, recommendations or challenges in the comments section.