The packaging labeling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal Quality Management Systems (QMS).

Furthermore, the QMS that the artwork capability is managed under should, in some way, link to the company’s corporate level QMS.

Where third party service providers are used to provide all or part of the overall artwork capability, these operations should also be covered by an appropriate QMS which is again linked back to the company’s corporate level QMS.

Therefore, when auditing artwork capabilities, evidence of operating QMS(s) should be obtained. Within the relevant QMS(s) there should be Policies and Procedures which dictate how artwork will be managed. It should be possible to trace the link between all relevant QMS’s through the relevant Policies and Procedures.


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.

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