How Skyepharma helps its clients for EU, US, Russian and all other markets ?
Why serialization in the pharmaceutical industry?
More and more medicines are being counterfeited or falsified. Currently 10% of medicines sold worldwide are counterfeit which causes serious damage to public health. This presents a risk to the patient and brings problems associated with the black market. Counterfeiting is estimated to cause 700,000 deaths annually.
It is therefore crucial to secure the supply chain in the fight against Falsified Medicines.
Health authorities and companies have therefore put in place measures to trace products. This process is named serialization which leads us another step closer to patient safety.
Since 2017, Skyepharma has secured its industrial and supply chain expertise, particularly in product serialization and aggregation. We have developed the necessary equipment and skills to understand and support the challenges of our customers on a global level. We are committed to fighting counterfeit products; and we want to make our supply chain transparent. This is why all our products leaving our site are serialized and aggregated when it’s necessary. Choosing us as your partner allows you to be in full compliance with product traceability.
What is serialization?
The serialization system allows the verification of a drug’s compliance from the distribution to the delivery then to the patient. This regulation entered into effect in the European Union on the 9th of February 2019.
All medicine boxes have a unique identifier (Data Matrix code) which is affixed at the exit of the packaging lines. All the identifiers of the boxes are then entered in a global database (in a European list and in the national list). At the time of dispensing all the boxes are scanned to check if the drug is in the database or if it is a falsified drug. Each box is also equipped with tampering evidence device (it can be checked whether the packaging of a drug has been tampered with).
In order to ensure that the code is read and compared with the database, pharmaceutical companies must equip themselves with computer systems dedicated to the serialization process. These operations to verify the authenticity of the medicinal product must be carried out prior to dispensing it to the patient. The steps are as follows: verification of the tampering evidence system, scanning of the code, verification on the file, deactivation of the used code to prevent its reuse.
The unique identifier of the serialization is composed of the following elements:
- Serial Number
- Expiry date
- Lot Number
These elements will act as an “identity card” for the drug.
Data from the European system will not be used to trace or track the location of the product at a specific time. Laboratories will not be able to access drug prescription or patient profile information. It is a drug verification tool that strictly adheres to the GDPR. Only health authorities can access this data in the context of falsification, pharmacovigilance or pharmaco-epidemiology.
Aggregation in pharmaceutical industry
The serialization is done at the box level. In order to move to the next steps of the supply chain, the aggregation process must be set up. The boxes are reconciliated in batches, in crates and then on pallets. At each stage a label is applied and scanned. Each scan is saved in a database before being passed on to the next participant in the supply chain. In this way, we have a global view of the product throughout the entire supply chain as well as traceability of the processes.
Serialization at Skyepharma
The implementation of the serialization at Skyepharma was a big challenge, with strong involvement of our automation and IT experts.
We are following the processes of GS1, the global network that implemented Data Matrix and GTIN. The standards they offer support us in the supply chain. A lot of countries are based on this model, which allows us to be globally consistent.
We have equipped all our packaging lines for serialization and aggregation. The packs are marked with a 2D data-matrix to identify them individually. With this process, each carton is designated to a batch and finally to the pallets.
The serialization being on 5 levels, we have chosen integrators/partners to carry out the 5 steps.
Level 1 = it concerns machines, scanners, …
Level 2 = corresponds to software
Level 3 = corresponds to the server and concentrates all the data management. For these 3 levels, the data is centralized on Seavision site server.
Level 4 = these are the tools for communicating data with the client. Either the platform is imposed by the customer or the partner is chosen. For the connection with our new customers we use TraceLink platform which is the leader in this field. It has the advantage of being able to connect with any other platform and therefore with any type of customer.
Level 5 = it is either up to the customer or the marketing authorization holder to deal with the authorities.
We stand out in terms of traceability because our serialization and aggregation are made up of automatic lines all the way to the crating phase.
Our further actions :
Aggregation is not mandatory everywhere yet. However, we have decided to anticipate future regulations. For example, we have integrated aggregation into our processes which is an important strategic choice that is part of our long-term strategy and development.
This allows us to be equipped for all markets where aggregation is (or is going to be) mandatory, including US, Russian, Saudi-Arabia, etc. The Russian aggregation is complex and will be compulsory from the 1st July 2020. We are ready to offer it out to our clients for that date.
We also plan to add a dedicated end of packaging line to increase our serialization and aggregation capacities at Skyepharma.
“Skyepharma is now fully ready to serialize and aggregate all of our products in addition to offering it as a stand-alone service to the customers that may have a one-off demand or don’t want to invest in this specific technology.” says Laurent Rigaudeau, Business Development & Marketing Director.
Contact us to learn more about serialization and aggregation.