Serialization solutions: 6 functionalities for lasting success
Implementing a serialization solution in the pharmaceutical industry is a complex undertaking with innumerable challenges and pitfalls. Moreover, there are today almost 40 different legislations on drug serialization in place with varying deadlines and almost as many different requirements.
Evolving legislation and long-term compliance
In Korea, for instance, all pharmaceutical products have to be serialized since January 2016 as per the Pharmaceutical Affairs Act. In the United States, serialization requirements today are limited to marking the unit of sale with a unique data carrier. The Drug Supply Chain Security Act (DSCSA) requires that, by 2023, a pharmaceutical product is traceable through its entire journey. In Brazil, Resolution RDC 54 explicitly includes free samples, not just medicines intended for sale. However, following industry-feedback, Brazil is currently reviewing its legislation on drug serialization. In Russia, drugs are classified into three levels. Pilot serialization programs are supposed to start in November 2016 and pharmaceutical products of the first class have to be serialized from January 2017. The FMD Delegate act requires serialization solutions to be in place in February 2019 in the European Union. Serialization legislation is also in preparation in Japan, Saudi Arabia and many others.
The legal landscape for drug serialization is ever shifting which means long-term compliance is a twofold challenge. Not only will you have to respect changes in the markets you currently cater for. You will also have to be prepared to respect new legislations that are likely to come into place in markets not regulated yet. And what if you want to export to markets not yet covered by your serialization solution? How can you ensure compliance in the long term?
The key functionalities of a Level 3 serialization application
It is of utmost importance to select a serialization software that has strong capabilities at all levels of technology, but most importantly on level 3. Level 3 of a serialization solution should provide key functionalities in the following areas:
Many serialization solutions on the market have only partial configuration capabilities, and some offer no configuration whatsoever. However, without configuration capabilities, it will be difficult to take more than one specific way of marking and serializing into account, let alone deal with different sorts of packaging or product categories.
A viable level 3 application needs to ensure correct AND secure data transmission. Otherwise you might be compliant with serialization legislation but not with data protection and storage requirements.
To offer benefits beyond compliance, a level 3 application should be able to extract meaningful serialization data and merge it with corresponding data from other systems for analysis.
Change Management Support
A standardized, centrally configurable serialization solution can adapt to changes in legislation and customer requirements while ensuring easy change-overs with minimal scope for human error.
A complete Level 3 solution should have centralized configuration capabilities with standardized line level applications to facilitate validation processes.
You need a robust IT system with the lowest RTO (recovery time objective) and highest RPO (recovery point objective) possible.
The future-proof drug serialization level 3 application
Today’s serialization solutions must be equipped to meet tomorrow’s requirements. Therefore, a Level 3 serialization solution needs to leave room for inevitable, future must-haves and be prepared to meet upcoming track and trace challenges. Only a fully level-3 configurable solution with comprehensive capabilities will give you enough flexibility to be prepared for unforeseeable change. To dig deeper into the subject and get more details on the above mentioned six key elements, download our whitepaper “Future-proofing serialization solutions: the importance of strong level 3 capabilities”.