Managing Serialisation – Authentication and Track and Trace

Managing Serialisation – Authentication and Track and Trace

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and two of the common serialisation models, Authentication and Track and Trace.

Product Information Notification

Typically, once product packaging of one or more levels has been uniquely identified, this information, together with other information related to the product and manufacturer is passed to an external agency database.

The information in this database is then used by the downstream supply chain and other agencies as described later in this series.

The triggers and grouping of the information transfers will vary according to the specific requirements of the legislation and the local business processes. In the simplest of models, the information can be transferred at, or around the time when the product packaging batch has been completed.

Authentication

Authentication is a term often used to describe the following process of checking the legitimacy of a product using it’s serialisation.

One of the primary purposes of serialisation is to enable individuals in the downstream supply chain to scan a product and compare the information on the product packaging with the information stored in the external agency’s database. If the two sets of information match and it is evident that the product has not been tampered with, then it will be highly likely that that the product is legitimate.

As an example, a patient might scan a product pack with a smart phone using it’s in-built camera. Using an application, the smart phone would then request information related to the unique identifier contained in the machine readable code and display it to the patient. The patient would then compare this information to the information contained on the packaging. If everything matched and the tamper evident sealing was still intact, the patient could have greater confidence that the product was legitimate.

A number of serialisation legislative models stop at the requirement for a means of Authentication. It appears that the recent European Union falsified medicines legislation 2011/62/EU is one such example. Many would argue that this level of serialisation provides an improved level of protection against falsified products and fraud that is sufficient, at least for the current round of legislation.

Track & Trace

Track and trace legislative models attempt to further improve the protection against the entry of falsified medicines into the legitimate supply chain.

Typically this is achieved by also requiring every change of ownership (and potentially location) of product to be recorded in the external agency database. Such legislation then also requires purchasers to verify the legitimacy of the product they are receiving by ensuring that the external agency database confirms that the seller had legitimate ownership of the product prior to sale. Rules are also required in the external agency database to ensure that the same product was not introduced illegitimately into the supply chain, or sold more than once from any single owner.

 This is a similar model to that used in many countries to control the legitimate buying and selling of motor vehicles, which also present a significant threat to the health and safety of the public if they are not legitimate. Many such models adhere to the following basic principles. Each car is identified by a unique licence plate. When a seller sells a motor vehicle, they have to complete a sales transaction which is registered in the transport agency’s database stating which vehicle (licence plate) they have sold and to whom. When a buyer purchases the motor vehicle, they register their ownership with the same agency and indicate who they purchased the vehicle (licence plate) from. The external agency database also contains other information that helps confirm the identity of the vehicle to anyone concerned, such as make, model, colour. This information is also used by buyers and sellers to confirm the legitimate identify of individual vehicles.  If the sale and purchase information matches then all is ok. If not, then investigation activity is triggered.

These additional track & trace requirements necessitate two very significant additional elements to be implemented over and above the Authentication serialisation model:

  1. Many, if not all, supply chain nodes handling product will need to be equipped to scan product and relate the unique identifier information to purchase, sales and other transactions and then communicate it to the external agency database. If they break product shippers down, they may also be required to serialise new shippers.
  2. To make (1) practical, many if not all levels of packaging shippers (e.g. bundles, cases and pallets) need to be serialised and the physical relationship between a shipper and it’s serialised contents built, communicated and maintained in the external agency’s database.

Element (1) is required to track the purchase and sales transactions down to the individual uniquely identified pack. For example, whenever a sale is made, all products which are physically changing ownership would need to be identified and the associated sale information updated in the external agency database. This requires the location in the supply chain handling the product at the point of sale to physically identify all the product being sold, down to its unique identifier. This is normally achieved by incorporating serialisation technology into the order processing and picking activities at a distribution location.

Element (2) is required to avoid the need for every such distribution location to break open all shippers and identify all uniquely identified packages within. A situation which would quickly bring the product supply chain to an effective halt.

Next Article

This completes the second article in this series.  In the next article we will look at Standards and opportunities presented by serialisation beyond legislative compliance.

http://www.pharma-iq.com/logistics/columns/managing-serialisation-authentication-and-track-an/

No Comments

Post a Reply