It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps, regardless of the scope of the change that was intended to be made. We are aware of many instances where unintentional changes have occurred to an artwork that would not have been picked up if people were only verifying that the intended changes had been made correctly.
Typically, artwork checks are categorized into four areas:
• All text, characters and symbols are present, correct and, where appropriate, consistent with source text documents.
• All graphical elements are present and correct.
• The intended meaning of the information is clear and as intended.
• All technical requirements have been met, e.g. barcodes, Braille, size, varnish finish etc.
Clearly, in order to verify the above, the individuals performing the checks need to have access to the appropriate requirements information. This is one of the reasons why we would recommend the preparation and formal approval of a change requirement or “brief” document to be included in the artwork process.
It may also be appropriate for different people to verify different aspects of the artwork. For example, qualified proof readers may carry out detailed text and symbol verification activity, whilst local country representatives might verify that the intended meaning of information is still clear when laid out on the artwork.
As an auditor, you should look for evidence that all aspects of the artwork are formally reviewed at the appropriate critical control points. Furthermore, it should be clear who is checking which aspects of the artwork and that all aspects are being verified.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labeling artwork management capabilities in the pharmaceutical, healthcare, and other highly regulated industries. Please help us improve the thinking by adding your comments and share this with others who may have a view.