Documentation for drug serialization with PharmaliZr

Drug serialization is a crucial process to ensure the traceability and authenticity of pharmaceutical products. Serialization documentation includes the steps necessary to get started with the PharmaliZr solution.

How to guarantee the authenticity and traceability of pharmaceutical products? #

PharmaliZr software complies with the European FMD Directive 2011/62/EU (Falsified Medicines Directive) on drug serialization. This is a process that involves assigning a unique serial number to each medicine box. This number includes information such as:

• the date and place of manufacture;
• the batch number;
• the expiration date;
• and the product code.

When the product reaches its final destination, the serial code is scanned and checked to verify if it is authentic and not falsified. The data thus collected is then sent to a centralized system. Regulatory authorities can access this information and ensure that medicines are always safe and effective.

Serialization is part of the regulatory framework for pharmaceutical practice. Healthcare professionals are therefore required to have serialization software that allows them to communicate with the national medicines verification system. The PharmaliZr solution meets this requirement for both PUI and community pharmacies.

PharmaliZr is a system for verifying the authenticity and traceability of a medicine from its manufacture, to its distribution and effective dispensing to the patient.

This system involves placing a unique identifier on each medicine box in the form of a Datamatrix code when it is distributed. All codes are loaded into a central database. The Datamatrix code is then scanned at the time of receipt in the pharmacy, then compared to those recorded in the central database. This is to verify if the medicine is authentic or falsified. In addition, each serialized medicine is equipped with an anti-tampering device.

How does drug serialization work? #

Serialization involves the use of a series of unique codes for each medicine. These are generated using a pharmaceutical product management system (GPP) that provides a unique code for each product and each batch.

The GPP can also provide additional information about the medicine, such as:

• the batch number;
• the manufacturing date;
• the serial number;
• the manufacturer;
• and the place of manufacture.

This information is then printed on the medicine packaging or on a self-adhesive label. The data can be read using a barcode reader. These codes allow pharmaceutical companies, distributors and pharmacies to verify the authenticity of medicines and track them throughout the distribution chain until they are dispensed.

Elements of serialization documentation with PharmaliZr #

Serialization documentation includes user guides that detail the steps necessary to get started with the PharmaliZr solution, including:

• creating an account;
• scanner configuration;
• serialization;
• quarantine;
• dispensing.