We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in any subsequent quality control steps.

For this reason we would recommend that, when approved by the necessary cross-functional stakeholder group, the artwork is complete with respect to all information that will be presented to the prescribers and patients.

Furthermore, any information on the artwork which is used to identify it throughout it’s subsequent development or use should also be present at this time. This helps avoid gross errors caused by the wrong artwork/packaging component being used.

In addressing this last point, it will often be necessary to understand how any 3rd party service providers identify artworks and packaging components in their processes.