Traceability®

Drugs traceability and validation in the pharmaceutical industry

Traceability is the most effective way to secure and control an efficient distribution of pharmaceutical products. It constitutes an essential instrument to face issues such as illegal traffic and drugs alteration. With the biunivocal identification, real time registry of each stage of the distribution chain and validation by the patient-as the last step- we obtain the complete information concerning the origin, logistic process, and consumption of any drug.

What is traceability?

Traceability is the set of mechanisms and norms which allow registering and rebuilding all along the supply chain, the history of the localizations,  transport and use of one item by means of a registered identifier.
Particularly in the pharmaceutical industry, it is the group of events that allow to create the path for each product, starting from its production (or launch into the market) to its final consumption by means of a Univocal Code. Traceability = each product to each patient.

What is validation?

Validation is the action by means of which, the final patient or health professional can prove the authenticity of a drug thanks to the information arising from Farmatrack.

Which are the needed requirements to incorporate traceability?

  • To provide a univocal identification of the product.

  • To integrate Farmatrack® into the product distribution process.

Benefits:

  • It allows performing a follow-up in the path of each product, all along the distribution chain, from its source until its consumption.

  • It facilitates audits for error detection and anomalies in the distribution related processes

  • It offers transparency for the consumer, who can validate the source of the product.

  • Certainty in delivering the right products

  • Decreases the patient’s “risk of death” factor.

  • Determines the physical location of each product, individually in the entry, storage and distribution processes.

  • Assures compliance with the conservation and handling processes

  • It makes possible to assign responsibilities.

Technologies where we operate

Farmatrack® has been approved as the drug traceability solution that complies one hundred percent with GS1 standards. Likewise, it also complies with the GMP norms of the pharmaceutical industry and has passed the quality and security tests of the most important laboratories of the market.

The system works one hundred per cent in the Web, under a SaaS model. It has been developed on a JAVA platform and the data treatment and assurance comply with the industry’s highest standards. The communication and the data exchange with external systems are performed through the web services.

The unit identification, reading and data transport mode supported by Farmatrack includes all the methods homologated and currently used in the market: Lineal Barcode (GS1-128), Datamatrix, and RFID. This technological breadth allows a quick implementation and a high capillarity rate to integrate the solution for all the actors of the supply chain.

Likewise, the identification processes are adapted to the production or reception models of products of each laboratory: printing, tagging, identification at source, etc.

RFID

Código de barras lineal

Datamatrix

Given its development and design features, using Farmatrack will allow:

  • Unified Operation – all the actors involved online –maintaining an exclusive data model per user.

  • Fast implementation

  • Low investment in technology and infrastructure.

  • Dynamic operation: it does not require changes in the logistic operation.

  • Practical implementation: it does not require additional resources

  • A secure model: Encrypted Database – Multiple key certified by each actor.

  • 24x7 availability

  • Multi-Laboratory, Multi-Distributor, Logistic Multi-Operator operation.

How does it work?

Farmatrack® is a transactional engine. A configurable workflow which bases its operation in the “biunivocal” identification principles of a product.

Each unit is identified at source in the process of manufacture or reception (access to the laboratory), by means of a biunivocal code incorporated to the product by means of different methodologies (Tagged at source, identification by ink jet or laser, etc.).

Once the identification process has taken place, each “box” becomes unique. It is a same lot, with the same expiration date and each unit that composes this set is an entity in itself which could be identified and validated all throughout the distribution chain.

This way the traceability process is initiated, generating in a database in real time, each one of the transactions that imply the different instances of the distribution of the product: activation, release, transfer to distributor, internal logistic, sale, delivery to drugstores and intermediate entities, reception by each responsible actor until it reaches the consumer. Then comes the validation of the product by the patient or by the health professional in charge of its application.

The system contains multiple validation cycles depending on each actor of the distribution cycle who receives the product, being the patient the last one validating its consumption.

Each stage of the cycle of the units is validated by the different actors (from the laboratory to the patient) and registered by the system.

Main Benefits:

1. Traceability in real time

2. Detection in real time of the attempt to distribute products which were adulterated, stolen or from a doubtful source.

3. Improve the consumer’s trust regarding the origin and quality of the acquired products (the consumer can verify through the website, SMS or by calling a 0800 number, the source of the product and its authenticity).

4. Improvement of the image of the laboratory when providing the consumer validation methods and product assurance.

5. Information Collection.

6. Verification of the distribution chain: Origin, delivery, destination of each sale, path of the product.

7. Control of refunds and returns.

8. To accurately know the physical location of each unit, facilitating the recall tasks.

9. Optimize the security processes and improve the illicit events follow-up.

10. Save in insurance costs and other general costs of the distribution process.

11. Optimization of inverted logistic circuits.