Executive summary. A hold works when staff can see what is held, why it is held, and who can authorize the next step.
Definition
A product hold is a temporary restriction intended to prevent use or movement while a concern is assessed.
Make the hold visible
Identify the affected product and packages, the reason, the time the hold began, and the person responsible for follow-up. The physical location and the record should tell the same story.
Write the hold reason so receiving, inventory, and clinical staff all understand it. Vague labels lead to accidental release or unnecessary delay.
Treat release as a decision
Release should follow documented evidence that the concern is resolved and, where appropriate, approval from an authorized reviewer. Note what changed between the hold and the release.
If the product cannot be released, record the final disposition and the related communications. That closes the evidence trail for the item.
Frequently asked questions
Can a hold be removed because the product is needed urgently?
Urgency does not remove the need for a documented, authorized decision. Define escalation routes for time-sensitive situations in advance.
Referenced standards and further reading
- FDA: Identification of Suspect Product and Notification ↗U.S. Food and Drug Administration
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