Implementing Serialisation in a Contract Manufacturing Organisation: 6 things to consider when selecting a vendor

Legislation around the Falsified Medicines Directive 2011/62/EU has been widely discussed for some time now and the deadline of 9 February 2019 is fast approaching.

For a Contract Manufacturing Organisation (CMO), the task of optimising for regulations on Track & Trace can present more challenges than most. Lower margins, a lack of resources and a lack of internal IT structure can all present challenges not typically experienced by larger, multi-national drug manufacturers.

Rather than asking whether they will serialise lines, packaging sites are now looking at how they will do this, and before you get started, there are some things to consider. One of the first and most fundamental steps in a successful serialisation strategy is choosing the right vendor – one that is experienced, capable and that has proven their capabilities. Remember, the success of your serialisation project is just as important to your vendor’s business as it is to yours. Use these tips to ensure you choose the right partner for your site.

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