From 9 February onward, pharmaceutical companies can no longer legally put products on the European market unless they comply with three critical safety feature requirements: every pack of medicines will be tamper-evidenced; carry a 2D data matrix encoding a Unique Identifier (UI) and the UI must have been uploaded into a Europe-wide system of repositories for systematic checkout at pharmacies.
Achieving readiness to comply with these requirements is a huge undertaking and the question being asked is: “How realistic is the prospect that Europe will be ready in February 2019?” To answer the question, let us look at this as a project — a big, complex project involving many different stakeholders who each have to do their part and be ready, on time.
But — despite plenty of evidence to the contrary — big, complex projects can actually be brought to a successful conclusion in the hands of experienced professionals, following best practice and using the right tools. The question is, what is the state of the EU European FMD Readiness Project when looked at this way?
Breaking the problem down
The starting point, as every experienced project manager knows, should be a critical early project deliverable: to define a breakdown structure to organise a project into manageable chunks of work. So, let us consider the major chunks of work needed to be undertaken to achieve EU-wide FMD compliance.
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