The pharmaceutical industry has taken significant steps to implement serialization mandates across the globe to reduce the problems of counterfeiting, theft, diversion, and false returns to manufacturers. Product serialization has helped the pharmaceuticals industry to ensure the integrity of its products when they are transferred between the different stops on the supply chain from contract manufacturers to wholesalers to dispensers and finally to the patient.
This positive effect on the security, stability, and reliability is largely due to the creation and implementation of effective business processes across packaging, importation, sales, exports and returns across CMOs, 3PLs, Customers and regulators on a continuous, ongoing basis. In addition to complying and adhering to the global serialization regulations, managing day to day serialization operations has become an equally important part for the success of the overall project.
Key areas to focus
- Resource Management
While you will want to have a single point of contact managing the Serialization project, no one individual or function can take care of all the activities. It is important to have an experienced serialization team involved to manage the end-to-end serialization project in this complicated world of serialization. Having a strong team will help companies to reduce the complexities of the project and also create a strategic value chain by aligning the business goals with the project and giving an edge over their competitors.
- Supply Chain Management
As pharma manufacturers and their contract partners serialize drugs and ship them around the world, supply chains will need to be closely monitored to achieve continuous compliance and prevent supply chain disruptions that occur from the complexity of the global regulations.
- Data Management
Serialization offers pharma a rich mine of data which results into creating complexities for managing operations if the team doesn’t have a data driven approach to leverage these data to boost their operations. Efficiently managing and reporting these data to the required partners and authorities are also important to solve disruptions much quicker.
- Compliance updates
Varying serialization and reporting requirements of national governments and global regulators makes it really complex for the pharmaceutical companies to keep a track of all the upcoming Serialization and Traceability requirements. Pharma companies need to keep a track of new and emerging country compliance & coding requirements to have an effective readiness plan in place which will address their immediate requirements and value add to their long strategic goals.
- Level 4 Validation
Once you have implemented your level 4 solution software and have completed your initial validation it is important to re-validate the corresponding system changes when any module is released to ensure your software is in the validated state and especially if it is on multi-tenant architecture.
Pharmaceutical industry is a highly regulated industry where the audits and checks are being performed by the regulatory bodies frequently. It is important for the companies to understand the details of various validation documentation that they would receive from their Level 4 solution providers and to ensure that they cover qualification of all of their unique internal processes and with their business partners along with the validation of the system.
- Impact assessment for new releases of a Level 4 system
With upcoming and changing regulations and requirements, new releases of a Level 4 system are a very common thing. The new release can be either for Implementing a new feature or fixing the bug of an existing feature. However, what is critical is with every new release that you perform a risk-based impact assessment to determine how this change will impact your internal process and whether any validation is necessary. For bug fixes, you can retest if you have reported an issue with your solution provider.
- Level 4 system health check
System health check will help companies in identifying the potential risks and errors which might be impacting the performance or progress of the project. Regular system health check will also improve efficiency, provide sustainable organizational structure, and value beyond compliance. It is the benchmark against industry best practices and help the companies in carrying out the operational activities timely and effectively.
CosmoTrace can help you in this journey
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations. We work with different vendors across the globe and are certified Tracelink implementors.
We are well versed with the compliance regulations for various markets and can help you with implementing the serialization project to meet the deadlines.
Our list of services that can be tailored to your needs to ensure that all your concerned areas are covered. The services include:
- Serialization project management
- Technical consulting
- Level 4 system validation
- EMVO alert management
- Impact assessment for Level 4 new releases
- Level 4 system health check