What are the steps for serialization in the Pharma supply chain?

What are the steps for serialization in the Pharma supply chain?

Pharma serialization is the process of assigning a unique code number to the packaging of each drug or sealable unit of medical equipment. There are two things to consider in this definition first is a unique number and the second is drug packaging.

The structure of this unique code number is defined within the regulations of the country. The definition of the code number is within the regulation of many countries is largely similar and follows GS1 standards.

Packing of pharmaceutical products has three main parts:

Primary Packaging

Packing in contact with drugs is the primary drug. The most common primary packaging is the aluminum blister used in the vial and bottle industry. Other than the American and Indian market the serialization of the primary packaging is not a compulsory requirement. Because in these market patients can purchase the primary packaging.

Secondary Packaging

The packaging contains the medicine with primary packaging such as packed in a carton. The serialization of this packaging is compulsory for regulation compliance. But EU-FMD regulations require Tamper Evident, along with serialization to ensure that the medicine is first opened by the patient.

Tertiary Packaging

For B2B operations in the supply chain medicines are packed into tertiary packagings such as cases, pallets, and bundles. The serialization of tertiary packaging is a must and is important to ensure traceability in the supply chain.

Implement Pharma Serialization

When preparing regulations on Pharma serialization legislators use guidelines from GS1 organizations which are specialized in traceability. The structure of the serial number is like a 2D Data Matrix code that meets the regulations pharmaceutical market. The process of serialization is completed when this code is printed on the packaging.

To implement the Pharma Serialization following steps need to be taken:

GLN and GTIN:

GLN is the Global Location Number assigned to the locations to be identified by using this number. While GTIN is the Global Trade Item Number which is a globally unique 14-digit number used to identify trade items. These number helps to track the pharma supply chain across the globe.

Serial Number: Serial number must be unique for each GTIN and it's a numeric or alphanumeric character sequence consist of maximum digits.

Lot Information: Lot information is production information of the company such as name, address, country, ownership.

Expiry Date: Expiry details of the drug are mentioned in a separate area.

Most Popular Serialization Method

The common method popular for pharma serialization is the Thermal inkjet and Labeling Technology. Thermal inkjet print 2D Datamatrix on different smooth surfaces at high speed and resolution. White Labeling is used for packaging such as bottles, serum, nylon bags which cannot be printed directly.

Enhanced Supply chain Traceability

When the serialization process is completed the drug becomes traceable throughout the supply chain. The movement of a serialized product is electronically recorded through its complete life cycle with a track and trace system. It is no longer possible for a product, every movement of which is recorded and updated in real-time, to be subjected to illegal activities.

She is a Digital Marketing Strategist in a Software House based in the USA and offers Business Intelligent Solutions. She is writing articles and blog posts for the past six years.