New Trends & Technology: Pharmaceutical Serialization and Track & Trace
Author: Rodrigo Sanchez
Content provided by Ian McDonald, Electronic Engineer at Masipack
What is the Difference Between Pharmaceutical Serialization and Track & Trace?
Pharmaceutical serialization is the application of a unique identifier (UID) to each product produced. The regulations vary from country to country, with some requiring each unit dose to be serialized, and other regulations requiring the serialization of the smallest commercialized unit. In this article, we will consider the smallest commercialized unit. The UID is a code, either numerical or alphanumerical, that is used to track the product throughout the supply chain. After applying a UID to the carton, the code is verified and, if it is damaged in any way, the carton is rejected. The cartons are then placed in a case. This case is given a new UID which represents the case, as well as each individual carton inside said case. If a rejected carton is found inside the case, then the entire case is rejected and must be reworked. This process is repeated with palletization.
All of this information is gathered and sent to the cloud where each pallet, case, or carton can be tracked and traced to not only see where it is currently in the supply chain, but also see where it has been, from production, through distribution, to the end-user (1). This allows for easier recalls and allows for products that have been stolen to be marked as such.
Why the Need for Pharmaceutical Serialization?
Globally, pharmaceutical companies lose an estimated $75 billion annually due to stolen and counterfeit products. This is one of the leading reasons driving the implementation of pharmaceutical serialization. The enactment of pharmaceutical serialization will protect the consumer, as it will make counterfeit products more difficult to manufacture. However, simply serializing a product is not enough; the ability to track and trace the product throughout the entire supply chain is essential in reducing stolen and counterfeit products.
How Can I Learn More?
Today, November 9th, the International Society for Pharmaceutical Engineering (ISPE) is holding five sessions on topics pertinent to pharmaceutical packaging at Pharma EXPO 2016 (co-located with PACK EXPO International 2016), highlighting the arrival of serialization. If you are attending Pharma EXPO today, it would be beneficial to join at least one of these sessions.
When Will I See Pharmaceutical Serialization in Action?
The implementation of pharmaceutical serialization begins in the U.S. in November 2017 and in the E.U. in 2018; if you are in the pharmaceutical industry, you must be prepared for this. Consult a packaging equipment specialist to recommend a pharmaceutical serialization solution that will suit your company’s needs.
Mr. Sanchez is Vice President at Masipack Group, and has 30 years of experience in the packaging industry.
1: Chatterjee, B. (January 2015). Serialization and the Drug Quality & Security Act. Retrieved from http://www.pharmamanufacturing.com/articles/2015/serialization-drug-quality-security-act/