One Year to EU FMD: How to Achieve Compliance by 09 February 2019

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Today marks exactly one year to the deadline for compliance with the European Falsified Medicines Directive (2011/62/EU).

Here's a month-by-month break down on how to comply and optimise your pharmaceutical packaging lines before 09 February 2019.

One Year for EU FMD Implementation: A month-by-month guide to compliance

With one year to go for pharmaceutical manufacturers, packaging sites and Marketing Authorisation Holders (MAHs) to achieve compliance with the Falsified Medicines Directive, the team in Crest Solutions have put together this guide to help you meet the deadline. 

Jobs to be done to achieve compliance: What, How and When

  1. February 2018 - Crucial to the success of your project will be internal senior management engagement. Serialisation is a corporate decision and you need to secure buy-in as soon as possible. Also in February, assemble your internal task team. This group will be cross-functional, from all corners of the organisation. These people have separate interests in your project and you need to properly scope all requirements from the beginning of the project. 
  2. March 2018 - Create a URS (User Requirement Specification) document and engage vendors. A vendor decision should be made by mid-March. For guidance on how to select a vendor, read our free white paper that covers 6 Things to Consider when Selecting a Vendor for Serialisation.
  3. July 2018 - By now you should be in system design together with your vendor for Serialisation, with clear understanding on upcoming project stages to avoid unnecessary delays.
  4. September 2018 - FAT (Factory Acceptance Testing) should be taking place now. 
  5. October 2018 - Validation should be completed, including SAT, IQ and OQ. Engage your operators and team on the line in training at this point, to ensure that go-live is not affected by easy-to-solve knowledge issues. Human error is the number one cause of lines being down in pharmaceutical plants. Avoid this by learning more about the type of training available for and required by your team. For more info, learn about Competency Based Training modules from The Pharmaceutical Academy. 
  6. November 2018 - Complete PQ and team training documentation.
  7. December 2018 - Optimise SOPs and production processes. Leverage the local support offered by your vendor at this stage, to ensure knowledge transfer and smooth running of processes. Crest Solutions offers embedded engineers to sites that are committed to achieving full line efficiencies and product excellence. Learn about our embedded engineers.
  8. January 2019 - Sit back and relax, safe in the knowledge that you have achieved compliance with the Falsified Medicines Directive!
  9. February 09 2019 - Press the button to send serial number data to the European Medicines Verification Organisation (EMVO).

Now you know how to achieve compliance for the EU-FMD, there is no time to waste. It can be done! 

The team in Crest Solutions is here to help - we still have limited space for new clients to advise and implement solutions in time for the deadline in 2019. 

You can get in touch with us here. 

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