Artwork Auditor Tip 4 – Are critical control points adequately defined?

Artwork Auditor Tip 4 – Are critical control points adequately defined?

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed.

A typical artwork change management process will divide the development of new or changed artwork, and it’s subsequent implementation, into a number of logical steps. Ensuring that there are clear control points in the process that must be fully completed before proceeding is a useful way to minimise this risk.

Typical control points might include:

• Approval of the definition of the change requirement.
• Approval of the artwork.
• Approval of any printer proofs.
• Approval of packaging components for use.
• Batch release to ensure correct version of artwork used.

Look for evidence of clear control points in the process when auditing artwork capabilities. We would suggest that these control points should include the requirement for the appropriate group of stakeholders to sign that they are happy to proceed.


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 For a hard copy of the booklet, contact us at

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