12 September 2018

Serialisation: the big challenge

From 2019 onwards, every box of medicine prescribed in Europe will have to carry a unique identification number. Called serialisation, this plan was presented on the 19th of October during agap2 Life Science’s breakfast, which brought together several professionals from the pharmaceutical industry. Nicolas P., Project Manager - Industrial Development Service at Antares, a company specialising in serialisation and data processing, and Amélie B., Serialisation Manager at Aguettant Laboratories, shed light on the impact and the challenges of this transformation.

WHAT IS THE PRINCIPLE OF SERIALISATION?

N.P. : Serialisation is a legal requirement for all pharmaceutical laboratories to ensure each pack of medicine has a unique identification and to record this information in databases that will ensure their traceability. In concrete terms, this means a unique serial number that will be added to the Data Matrix (bar code or QR code on the medicines), in addition to other elements that are already mandatory.

WHO IS CONCERNED BY THIS?

N.P. : All laboratories, such as Aguettant, that produce medicines covered by the national social security are concerned and they will have until January 2019 to implement this European directive. 

WHAT CHALLENGES DOES THE SERIALISATION OF MEDICINES PRESENT FOR YOU, AS A PHARMACEUTICAL LABORATORY?

A.B. : The challenges are mainly industrial in nature. We must integrate the necessary equipment to implement serialisation and to guarantee the inviolability of all our sales units. The main challenge is to maintain our operating costs and the OEE (Overall Equipment Effectiveness) of our production lines.

The second challenge is related to data management. We must be able to store all of the serial numbers and to send them to the relevant authorities in order to guarantee the traceability of the batches. 

WHAT CHANGES WILL THIS INVOLVE?

A.B. : This will require considerable changes in terms of our processes, as we will have to have the necessary equipment to print the serial numbers on the boxes, in addition to the verification, storage and sending of these numbers. This will also require considerable training and support for the production staff in the processing of these serialised packages.

WHAT CHALLENGE DOES THE PATIENT FACE REGARDING THIS SERIALISATION SYSTEM?

A.B. : Around 10% of medicines are thought to be counterfeit throughout the world. This serialisation system is designed to limit the black market. When dispensing a box of medicine, the pharmacist will have to check that its serial number was correctly registered by the pharmaceutical laboratory beforehand. As such, each box of medicine that will be dispensed to patients in hospitals or pharmacies, will benefit from this extra traceability. Today, such systems are already in use in Turkey. Medicines are scanned at each stage of distribution to check that they have not been manipulated or sold on to the black market.

 

AGAP2’S EXPERTISE

Aymeric M., an agap2 consultant with Aguettant, is supporting the laboratory with their implementation of serialisation.

« I am an Automation and Industrial IT Engineer. In order to support Aguettant in implementing serialisation, I am working both on training the production staff on the new centralisation software, and on the maintenance of the new equipment in case of a breakdown or other problem. My job is to have a good command of the whole system, which is both automated and computerised in order to ensure it is optimised. »

Aymeric M., Automation and Industrial IT Engineer