loader

Are you testing your packaging containers before use?

A company recently received this 483 observation:

….. Establishment of the reliability of the container and closure supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Specifically, when I requested the firm’s management to review the release data on the packaging containers and closures, your director stated that the jars had been accepted without COA from the vendor and no other testing had been performed.

For more observations pertaining to packaging and labeling, see our new issue 1059  available today.  It has observations pertaining to quality systems, manufacturing controls, and medical devices.

Leave a Reply

Your email address will not be published. Required fields are marked *

Search GMP Trends

Did you know: Our entire report archive has been indexed! This means, our members can search across thousands of 483 observations and pinpoint the exact info they need!