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.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labelling artwork management capabilities in the pharmaceutical, healthcare and other highly regulated industries. Please help me improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our Top 20 Artwork Auditor Tips booklet, go to www.be4ward.com. For a hard copy of the booklet, contact us at firstname.lastname@example.org.