Serialization in the pharmaceutical industry
Medicine counterfeiting, supply chain theft and reimbursement fraud present a serious threat to public health and damage trust in brands. The pharmaceutical industry has a collective duty to ensure medicines are safe for patients and consumers to take and work as intended. That's why we are committed to meeting the latest pharmaceutical serialization and track & trace regulations designed to prevent falsified medicines. As a forward-thinking contract development and manufacturing organization (CDMO), in 2016 we launched a full-scale serialization project and invested around €7 million to ensure reliable and efficient serialization processes and infrastructure for our customers.
Meeting pharmaceutical serialization requirements
The growing problem of medicine counterfeiting has led governments, regulators and industry to take action in order to prevent counterfeit products from entering the market. The identification of individual product units through serialization is an important part of this. Packaging-level serialization of pharmaceutical products became compulsory in the US in November 2017 under the Drug Supply Chain Security Act (DSCSA) and will become compulsory in the EU in February 2019 under the Falsified Medicines Directive (FMD). Other regions have drafted similar legislation for product manufacture and import.
The latest serialization legislation requires an alphanumeric code to be printed in both human-readable and two-dimensional barcode form on the secondary packaging of prescription medicines. This individual identifier contains information such as product code (Global Trade Identification Number (GTIN) or National Trade Identification Number (NTIN)), unique identifier (serial number), batch number, and expiry date to track and verify the authenticity of these medicines at every stage of the pharmaceutical value chain. In addition, product packaging must include tamper-evident features, typically achieved using labels or glued folding boxes.
HERMES PHARMA employs user-friendly secondary packaging designs to satisfy these requirements. One option is a cardboard box that incorporates an additional fourth flap, rather than the three flaps traditionally found on carton packaging. This flap, which has sufficient space for the required serialization codes, is glued down and must be unstuck to open the box, acting as a tamper-evident mechanism. Furthermore, the flap can subsequently be tucked into the box to ensure the contents remain safe and transportable for ease of use.
The importance of serialization when outsourcing product manufacture and packaging
Serialization impacts on all areas of the pharmaceutical industry, from manufacture to marketing. It’s vital that every link in the development, production and supply chain meets the necessary requirements. This is particularly important when outsourcing production and packaging, and it’s essential to choose a partner that has the technical expertise, manufacturing technologies, IT infrastructure and regulatory understanding to meet the varying requirements in different regions.
At HERMES PHARMA, we combine regulatory and technical expertise to ensure our customers have the user-friendly packaging solutions they need to meet global pharmaceutical serialization requirements.
We offer customers:
- In-depth knowledge of global serialization requirements
- Serialization of secondary packaging
- Human-readable and two-dimensional barcode labeling
- Tamper-evident solutions for all our user-friendly secondary packaging options
- Successful onboarding of the leading track & trace solution providers Tracelink, Arvato and SAP
- Integration with other level 4 software solutions, such as Metronic, Antares and Zetes, if required