Pharmaceutical Companies Implement Serialization Obligations

A majority of pharmaceutical companies have spent a very large amount of time and effort in recent years implementing or upgrading new hardware, software and processes to comply with the mandatory serialization requirement.

In the European Union alone, according to the operating company of the central EU hub system 'EMVO', well over 2,000 pharmaceutical companies are technically connected (as of June 2020). It is important to mention, however, that these figures do not reflect the pure contract manufacturers (CMOs). Due to this, an even higher number of companies can be assumed to have been involved to a high degree in the implementation of the Falsified Medicines Directive in Europe alone - not to mention the implementation for other regions such as Russia, USA, China or Brazil.

Now that initial implementations have been made to meet the requirements, companies are faced with the challenge of efficiently operating, maintaining and expanding the serialization system for additional regions. For many companies, this leads to the conclusion that, for example, the initial choice of serialization software no longer meets the requirements for various reasons and a new partner is therefore sought.

In recent times, we have been holding numerous discussions with a large number of pharmaceutical companies that are considering replacing their existing system for precisely this reason. The experience gained from these discussions shows that the following criteria in particular are the focus of thought as accelerators for the search for alternatives:

For a successful transition to a new serialization solution, it is first advisable, as with any undertaking, to clarify the current situation. To this end, the following information should be evaluated within the internal organization in advance of discussions with alternative providers:

• What goals are being pursued with a change?

• What risks does a change entail?

• Which systems are needed or should be replaced (L3, L4, L5)?

• What is a realistic timeline for a smooth transition?

• Which markets / national databases are served and what is the company's role here (MAH/CMO)?

• Which and how many business partners need to be considered?

• How high is the number of serial numbers required annually?

• Which interfaces (ERP, L2 or L3 systems) have to be considered for a connection?

• What is the scope of the data migration?

This information and a target definition should form the basis for discussions with alternative providers and enable them to submit an individual offer.

However, many companies are currently concerned about which core activities they will have to perform as part of a transition project. For this reason, the most relevant activities from practice, using the example of a change of serialization system in the EU, are listed below in order to provide a better overview which should reduce this uncertainty:

1. Step: Adaptation of standardized specification templates for a reliable validation approach
2. Step: Custom configuration of the new serialization system in a qualified solution environment
3. Step: Standardized connection of all business partners and level 2 systems to reduce overhead
4. Step: Reset one of the OBP client connections by EMVO to use the new serialization solution
5. Step: Execute system validation and EMVO IQE testing.
6. Step: Move to the production environment of the new seralization solution
7. Step: Go live

The extensive experience we have already gained in this context shows that now is exactly the right time to change your serialization system. You will benefit from the following advantages:

As a proven serialization solution, the Arvato CSDB is used by more than 80 pharmaceutical companies and ensures a smooth serialization process as well as the seamless implementation of legal requirements. The Arvato CSDB offers Level 3 to Level 5 functionalities and efficiently carries out the complete processes. In addition, it enables holistic implementation of track & trace requirements, e.g. in the context of Russia.