Serialisation in Drug Production
Arvato CSDB Serialises - Securely & Legally Compliant.
Protection Against Counterfeit Drugs
According to the WHO, the trade-in of counterfeit medicines affects all countries worldwide and is increasing massively. At best, counterfeits are ineffective for end consumers - and in the worst case, they are life-threatening. The worst-case affects nearly one million people a year worldwide, where the toxic side effects of counterfeit drug products lead to death.
In order to effectively protect consumers, markets and manufacturers from counterfeits, a legally binding framework for tracing prescription-only medicines was created, for example, with the EU Falsified Medicines Directive (FMD) of 2011 and the Delegated Regulation (EU) 2016/161. Among other things, data matrix codes, database comparisons with national verification systems and solutions for detecting the integrity of product packaging (Tamper Evident sealing) are used.
Arvato CSDB - The Solution for Pharmaceutical Companies
A central element in the fight against counterfeit medicines is digitisation. The Arvato CSDB is used as a proven serialisation solution by over 80 pharmaceutical companies and ensures both a smooth serialisation process and the seamless implementation of legal requirements.
Arvato CSDB - Core Functions at a Glance
Drug serialisation is much more than a code on the package. Nationally as well as internationally, manufacturers and distributors have to meet the legal requirements regarding counterfeit protection.
The serialisation solution must integrate production lines, partners, customers & suppliers - this means comprehensive integration, adaptation of processes and high security measures. Whether at the intersections between ERP software and production and packaging machines, to the systems of external service providers or to national verification systems: The serialisation of medicines requires technical expertise, process know-how and the software solution Arvato CSDB, which reliably controls the entire serialisation process.
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Solutions & Consulting Expertise for the Pharmaceutical Industry
Importance of the topic of serialisation for market participants such as pharmaceutical producers, contract manufacturers, marketing authorisation holders or wholesalers.
Marketing authorisation holder (MAH)
Due to the ever-increasing global regulatory requirements, the topic of serialization is becoming a significant issue for the pharmaceutical marketing authorization holder. Within the production process, they must ensure that the various requirements are implemented before their goods can be released for marketing. Therefore it is recommended that the marketing authorisation holder introduces a system that supports him in orchestrating the relevant serialization processes across all stakeholders.
Arvato Systems offers such a solution with the Arvato CSDB, which not only exchanges master and production data with your business partners very easily via standard interfaces, but also fills the relevant data in the national systems. This enables smooth marketing and prevents additional costs.
Contract manufacturing organization (CMO)
As a contract manufacturer, it is essential for you to design your production processes, which includes the serialization process, efficiently and to network with your customers very easily and flexibly to exchange relevant serialization data. The Arvato CSDB offers you the possibility to orchestrate production orders between the packaging lines and your partner very efficiently.
On the one hand, the Arvato CSDB offers standard interfaces to all well-known line manufacturers to ensure smooth communication with your machinery. On the other hand, we use the Arvato CSDB gateway technology to request or receive production orders and serial numbers securely from your customers.
Pharmaceutical Wholesalers
According to the Falsified Medicines Directive, pharmaceutical wholesalers are also required to verify products physically in their possession and, if necessary, to decommission them. Wholesalers must carry out these processes in different cases.
Based on its experience in the digitization of business processes in the logistics sector, Arvato Systems supports and assists licensed pharmaceutical wholesalers with the necessary change processes. The core of this offering is the Arvato Smart Logistics Platform - Healthcare Suite. This in turn is part of the proven platbricks platform (Arvato Smart Logistics Platform), which has been supporting logistics companies in digitizing their business processes since 2016.
EU countries
Arvato Systems currently supplies National Verification Systems for 17 countries in Europe and successfully connects them to the EU hub. The European Medicines Verification Organization has selected the expert for serialization & anti-counterfeiting as its official service provider. Arvato Systems relies on its own team to implement numerous projects in an international environment.
9 Good Reasons for the Arvato CSDB
The standardised ...
- SECURE - reliable exchange of serialisation data with external partners.
- FLEXIBLE - simple connection via standard interfaces.
- SEEMLESS - fast and complete integration into existing IT landscapes.
integrative …
- TRANSPARENT - reliable reporting of all serialisation events.
- SIMPLE - seamless connection to existing systems (e.g. ERP & MES).
- OVERARCHING - use at both site and line level.
Solution for Drug Serialisation.
- COMPREHENSIVE - management of complex workflow processes.
- INTERNATIONAL - perfectly tailored to national and international regulations.
- CONNECTING - flexible connection to all important line manufacturers.
Why Arvato Systems
Today, our serialisation experts support pharmaceutical manufacturers and retailers worldwide in making medicines counterfeit-proof with IT consulting/process consulting and our own software solution Arvato CSDB (graphic: excerpt customer list).
Our expertise in the healthcare segment covers the entire serialisation process chain end-to-end, from the product to the end customer. Other in-house developments, such as the platbricks Healthcare Suite, offer additional opportunities to optimise processes and expand existing systems.
17 European countries have entrusted us with the operation of their National Verification Systems. The associated regulatory know-how ensures that our customers always have up-to-date processes/systems and thus investment and action security in a complex market.
Focus Reference: Horus Pharma
Together with the Horus Pharma team, our specialists successfully replaced the legacy system for drug serialization with our proven and flexible solution Arvato CSDB (Software as a Service) within a few weeks.
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