Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it was not used to manage the creation or changes to all packaging artwork for the business.

Typically, it’s the products which fall outside of the mainstream of activity for a company that find themselves with no adequate packaging artwork management process. Product areas to look out for include:

  • Subsidiary company products.
  • Recently purchased products.
  • Products produced locally for local or regional use.
  • Products produced by 3rd parties.

When auditing artwork capabilities, look for these types of products and then seek evidence that their pack changes are being managed under a QMS which meets the standards we discussed in Tip 1.


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.

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 [email protected]
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