The importance of effective serialization communication practices and training for a successful traceability process.
Serialization is a long-term process that requires pharmaceutical manufacturers to not only install new technology to support the labelling of drug products, but also to update and adapt their internal and external systems and infrastructure. This is likely to evolve over the lifespan of the solution, as will the growth aspirations of companies in the industry.
In the fifth part of our blog series, serialization director Carlos Machado and our senior R&D product manager Matteo Barbieri discuss the importance of joined-up thinking and effective communication during the serialization process. This includes the need to identify the right support partners, keep abreast with new legislation, take a proactive approach to change and ensure training and processes are implemented consistently across all production lines and sites.
Engaging all business functions
Serialization needs to be integrated across all business functions, including IT, sales, marketing and regulatory affairs. A joined-up approach will ensure that the transition to a fully compliant solution will be as smooth as possible, reducing the risk of operational downtime. As deadlines move closer, keeping all teams updated of developments in the project will help to ensure it stays on track. Organizing quarterly meetings with representatives from across business functions will ensure full project visibility, helping to identify potential issues early on. It may also be necessary to increase the frequency of meetings as the project nears completion and the individual dependencies grow in importance.
Connect with experts
With so many moving parts and technical and logistical complexities, smaller and mid-sized companies are increasingly relying on third party providers to oversee the implementation of entire serialization solutions across sites. Choosing the right partner is essential. Factors to consider will include the provider’s track record, whether they demonstrate proactive planning and their understanding of the varying global requirements. Having a dedicated serialization team or expert in place will help to guarantee implementation effectiveness for long-term success.
Stay on top
Serialization requires all manufacturers to implement a solution in order to meet DSCSA and EU FMD regulations that will enter into force in 2018 and 2019 respectively. It is likely that the regulatory landscape will evolve over time and keeping abreast with new developments and communicating these with the affected teams will be important in achieving and maintaining compliance. Putting in place an effective communications plan during the planning process will help to support the flow of information throughout the business helping to avoid costly regulatory errors.
The final instalment of our blog series will discuss the inevitability and importance of serialization, highlighting the need to establish best practice and the advantages of standardization, flexibility and scalability to achieve short and long-term business benefits.
You can read more about the challenges, drivers and benefits of serialization here.