What is "track and trace" in the pharmaceutical industry?
The term “track and trace” is also used to describe traceability, which also includes the ability to determine the location of a product at any point in the distribution system.
What is Track & Trace?
Track and Trace is the operation by which information on the past and current status of each drug is recorded.
All drugs on the market are tracked on the basis of packaging using GS1 (Global Standards One) keys. The ability to track each unit of medicine is thus ensured by collecting information from each unit at each stage of manufacture and distribution. This track and trace system is also applicable to food products.
What are GS1 (Global Standards One) standards?
GS1 is a non-profit organization that develops and maintains global standards for commercial communication. The best-known of these standards is the barcode, a symbol printed on products that can be scanned electronically.
According to global standards (GS1), drug manufacturers and exporters must print barcodes at different packaging levels – primary, secondary and tertiary – to facilitate product tracking and traceability.
The barcode makes it possible to track and trace the origin of medicines, reducing the risk of genuine medicines being considered spurious, inferior or counterfeit.
The Track & Trace system is applicable in the United States, and the Falsified Medicines Directive is applicable in the European Union.
Track and trace pharmaceutical management worldwide
Pharmaceutical industries face challenges inherent in inadequate supply chain security (leading to theft, detour and even return of products), falsification and particularly stringent legislation.
These challenges, in addition to the worrying safety issues, threaten the sustainability of the sector by adversely affecting margins, brand reputation and research projects.
Many pharmaceutical distribution systems are made up of various structures such as manufacturers, wholesale distributors and pharmacies. It is therefore essential to have secure means of tracking and tracing medicinal products at different levels of the supply chain, through the implementation of product serialization. This is essential to meet the challenges facing the industry.
Track and trace in China
The compliance obligation stipulates that pharmaceutical exporters will adopt a tracking and tracing system and integrate its features for exported medicines using barcode technology in line with global GS 1 standards. This is a serialization and aggregation system.
- Primary packaging
These standards have a specific requirement for primary-level packaging: the integration of the 2D barcode (GS1 Datamatrix ) on medicines, encoding the unique product identification code and the unique serial number of the primary packaging box.
- Secondary packaging
A number of requirements apply to secondary packaging. These involve the incorporation of bar codes (1D or 2D) encoding the unique product identification code (GTIN), the unique serial number of the primary product identification packaging (GTIN), the batch number, the expiration date and the unique serial number of the secondary packaging.
- AT tertiary packaging level
Tertiary packaging requirement: this involves the incorporation of bar codes (1 D) encoding the unique product identification code (GTIN), batch number, expiration date and unique serial number of the tertiary packaging (shipper/carton).
It is also specified that, as part of the tracking and tracing system, manufacturers must keep a serialized file of exported pharmaceutical products for a minimum period of six months after the product’s expiration date.
Track and trace in France
France has also been at the forefront of advances in serialization. The implementation of regulatory requirements in France is designed to guarantee the effectiveness of batch recalls, reduce errors, combat counterfeiting and reimbursement fraud, and increase transparency in the distribution chain.
Since January1, 2011, French CIP13 coding regulations have required all pharmaceutical products prescribed and distributed in France to bear a Datamatrix barcode on their outer packaging.
Legislation governed by the French Health Products Safety Agency (AFSSAPS) requires each product to be printed with a 2D matrix barcode featuring the CIP 13 code, batch number and expiration date.
Track trace in other countries
Many countries have introduced regulations, directives and laws to implement traceability and tracking systems for pharmaceutical products and medicines.
On our map, you can find out the serialization and aggregation requirements in other countries.