With pharmaceutical supply chains growing longer, it has become necessary to incorporate serialization in companies. The issue of counterfeit goods in the market has been a global issue for decades, more so now with longer supply chains and higher demands for goods. According to WHO, an estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified*. Pharmaceutical companies have tried to combat this issue by working with contract development and manufacturing organization (CDMOs) to find serialization solutions that are sustainable, allow better distribution and reduce supply chain vulnerabilities such as theft, faulty goods, adulterated drugs and packaging or storage concerns. CDMOs are helping pharmaceutical companies to strengthen their manufacturing practices and reduce the challenges of authenticity across the globe.
Some of the challenges that CDMOs encounter while implementing pharmaceutical serialization track and trace are:
1. Taking care of Serialization for Multiple Clients
CDMOs work with different pharmaceutical companies and they provide in depth drug manufacturing and supply services to various pharmaceutical companies. As they have clients at a global level, they have to keep in mind serialization solutions of individual drugs per company. It’s crucial for CDMOs to have access to correct technology and to be able to work with various clients simultaneously. They should be able to modify and seamlessly serialize their products as well as the production and manufacturing lines for different clients.
2. Compliance Across Various Regions
CDMOs are generally responsible for handling the quality of drugs being distributed and to ensure companies are compliant with country/state specific government rules and regulations that have varying global and local standards. This is a huge challenge for CDMOs as they have to maintain extensive databases and have to ensure compliance for all.
3. Selecting appropriate coding technology solutions
CDMOs need to tailor their serialization and labelling solutions to meet the requirements of their different clients. Certain labelling solutions may require different technology and in other cases it could be different printers. It’s the responsibility of CDMOs to making the right decisions for labeling technology and coding i.e. barcode designs, label orientation and layout, etc. All of the labels must be manufactured within a specific timeframe so the supply chain continues functioning uninterrupted.
4. Having knowledge of various markets and their requirements
As mentioned earlier, CDMOs need to be well versed and knowledgeable with different markets and their requirements. They also need to make the right decisions specific to their clients, especially which needs to be based on analysis of the market. CDMOs need to make a call on the number of drugs to be serialized for a market and the type of serialization strategy they’ll use.
Serialization strategies have been adopted more commonly in businesses as of now however, there are still challenges that companies are facing to enforce this. With the help of the right kind of applications, a capable team, and a well thought-out serialization strategy, CDMOs can help pharmaceutical companies with their end-to-end manufacturing and other serialization challenges they may encounter.
CosmoTrace offer long lasting serialization solutions and we offer premium support and services that can help your business with serialization implementation. Our team of experts will make sure you are up to date with all global traceability regulations from start to finish.