We will break serialisation legislative requirements down into four elements to help explain them:
● Unique Identification
● Product Information Notification
● Track & Trace
In this article we will discuss the first of these, unique identification.
All serialisation legislation requires one or more levels of packaging to be uniquely identified with some form of “licence plate” or serial number. Furthermore, in all recent legislation, this identification must be applied to packaging using some form of machine-readable carrier.
In current legislation, the lowest level of packaging requiring serialisation is the smallest saleable unit, typically the secondary pack. As will be discussed later, some legislation also requires higher levels of packaging and shippers to be serialised as well.
Ultimately, serialisation of primary packaging (e.g. blister pockets, vials) and in some cases (e.g. tablets) the product itself may be required, as many would argue that this provides the best protection to the patient. Whist some regulators are discussing this, few are indicating imminent legislation.
There are broadly two approaches to ensuring that serial numbers are unique that are currently adopted by legislation.
In this model, an external agency manages all serial numbers for a particular market or region. They issue serial number blocks to manufacturers (and potentially other supply chain partners), who would then manage the application of those numbers to product packaging.
UNIQUE IDENTIFICATION = (UNIQUE NUMBER ISSUED BY EXTERNAL AGENCY)
In this model, a manufacturer will typically require a serial number [request and allocation management system] to ensure that enough serial numbers are available in the right locations to enable manufacture.
An alternative model uses a combination of product code and serial number to achieve uniqueness.
UNIQUE IDENTIFICATION = (PRODUCT CODE) + (SERIAL NUMBER)
Product codes, such as the internationally recognised Global Trade Identifier Number (GTIN) are unique. Therefore, in this type of scheme, the uniqueness of serial numbers need only be managed across all product of the same Product Code.
Given that product codes are normally unique to a single manufacturer, the management of serial numbers for a product can then become the entire responsibility of the individual manufacturer. Typically this simplifies matters as it is not necessary to ask an external agency for groups of serial numbers and it offers the opportunity for simpler rules-based serial number allocation and management to individual manufacturing facilities.
Having established which packaging levels need to be serialised and the method of creating and managing unique identifiers or serial numbers, we will now discuss the information that needs to be applied to the packaging and the mechanism by which this is achieved.
Information Applied to Packaging
Often, the information required to be applied to the packaging is not limited to the unique identifier or serial number described above. Frequently, additional information such as [Batch/Lot Identifier] and [Expiry Date] are also required to be included in the machine readable carrier. Often, if not already present, text describing this information must also be applied to the packaging.
This additional information allows people in the downstream supply chain to make use of the information to improve the efficiency and effectiveness of their processes without the need to obtain information from any other source.
As an example, dispensaries can scan the machine readable carrier, obtain information about the product contained within the carrier and compare this electronically with the prescription to help reduce dispensing errors.
There are many different ways in which information can be placed on a pack in order that it is machine readable.
Where serialisation legislation is concerned, two methods are typically currently mandated: linear barcodes and/or 2D/Datamatrix Barcodes. Radio Frequency Identification (RFID) tags have also been extensively discussed, but at the time of writing had not been mandated.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.
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