Implementing a serialization solution in time for new regulations in the US and Europe is a huge task. Serialization will transform the entire supply chain and requires pharmaceutical manufacturers to invest in new technology, adapt their current processes and systems and ensure staff understands the new regulatory environment in which they are working. With so much at stake, serialization director Carlos Machado and our senior R&D product manager Matteo Barbieri offer advice on how to plan for serialization, including understanding the scope and potential impact. They also discuss the importance of defining your project, particularly vendor and personnel selection, technical requirements and serialization strategic planning for challenges once the project goes live.
As a first step, you will need to assess your current capabilities in order to plan effectively and scope out the project. Take the time to understand how many products and production lines will be affected. It is likely that you will require input from senior stakeholders, professional project management and assistance from third party specialist partners. Having a roadmap in place early on will enable you to roll out the project across different sites and production lines with minimal disruption to normal business operations and put you on the road to success.
A pharmaceutical manufacturer may operate across multiple sites and geographies, making standardization – a key factor in simplifying your serialization set-up – difficult to achieve. Furthermore, serialization will impact all departments within a company, not just the production line. The warehouse, IT, quality assurance, production and marketing teams will all need to adapt to the new operating process to ensure an aligned company-wide strategy. It’s also important to engage any partners, such as contract manufacturers, packagers, third party logistics (3PLs) providers and distributors, to ensure seamless compliance at all stages of the supply chain.
With so many variables to navigate, choosing reputable and knowledgeable third-party providers to support your serialization journey is advisable, but requires careful consideration. Depending on the scale of the project, you may require a system integrator with specialist knowledge and project management experience who can deliver an end-to-end solution that integrates seamlessly into your existing structure. Regulations are likely to change over time, therefore identifying providers that can plan for the future and provide a solution that can be adapted without re-validating the entire system should be a key consideration.
Larger organizations will be faced with the need to connect thousands of systems across sites and countries. Time to run a test project to identify any weaknesses should be factored in at the start of your project to ensure that any issues can be resolved before the final roll out of the solution. This will allow you to remain fully operational and compliant. Serialization will also produce vast amounts of new data and companies of all sizes will need to consider how data flow, management and storage are integrated into the solution.
While careful serialization strategic planning at the start of the project can help guarantee the successful roll out, it is likely that challenges will arise once the solution is live. Identifying the potential issues in advance will ensure that you have a plan of action that will minimize any downtime. For example, identifying the appropriate maintenance technicians for the various equipment during the serialization strategic planning process will speed up response times should a technical error occur.
Pharmaceutical manufacturers have a lot to consider before, during and after a serialization solution is introduced into the company. Assessing the scope of the project early on and planning for implementation as soon as possible will enable you to stay on track and meet the new regulatory requirements in sufficient time, without having a negative impact on business continuity and performance.
Next up in the series, Carlos Machado and Matteo Barbieri discuss the importance of joined-up thinking and effective communication during the serialization process, highlighting the importance of taking a proactive approach to change and ensuring that processes are implemented consistently across all sites.