Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
As with other aspects of medical device design, medical packaging has its own unique set of challenges. Taking a big step back and reconsidering our assumptions can help us make the kind of impact necessary to ensure our future.