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Falsified Medicine Directive 3 of 5 – How to prepare for meeting compliance requirements?

What do European Pharmaceutical companies need to do in meeting compliance requirements in the United States?

They key is to purchase a system that enables the company to pass data on to the regulators in the most accurate and efficient way possible.  All companies in the supply chain have the obligation to report the data to the authority.  Authorities like the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act in the United States are providing guidelines on meeting compliance requirements.

Companies need to plan ahead and ask providers how they will pass correct data in a way that is consistent, high quality and validated. This is a fundamental change in the way the drug industry currently does business and is crucial in meeting compliance requirements. Before, all things that were manufactured physical objects and in the same a batch. Tomorrow there will be objects are physical but also virtual. Requiring each package to match the data in the box and each pack along the production line is different.

 

What do small companies and virtual manufacturers need to do to prepare?

They need to think about, what resources they will need to get this done. How much bandwidth do they have internally to get this done? When choosing a provider, they need to think about what is my side of the deal. Do I have to employ a project manager? How long will this implementation take and how much will they have to invest in serialization?  The compliance allegation is nonnegotiable, they have to get it done as required by Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA).  It is tricky and complicated challenge but there are dedicated experts to get it done

Big drug companies have teams of people with serialization in their job title, however, some small drug companies, have a one-person team, usually the head of manufacturing. These people wear 15 different hats, they don’t have the time to to get the job done because it is such a complicated process, it would totally consume them.

With rfxcel companies in the pharmaceutical supply chain are meeting compliance requirements in 60 business days. That is a big difference between service providers that stretch it for 5 or 6 months. At rfxcel, we like to take the burden away from the customer and actually help with data validation, data management, managing the training partners and designating teams for meeting compliance requirements. Other providers require them to really get their hands dirty and really get into this which requires companies to allocate more time and resources.

 

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil for over 13 years. Glenn focuses on building a company with industry leaders and experts including, Mark Davison.

 

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years experience bringing solutions to the Pharmaceutical industry.