If a potency test is out of specification, which action should NOT be performed?

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When a potency result is out of specification, the priority is containment and investigation, not release. Immediately quarantining the batch prevents distribution of potentially nonconforming material and preserves evidence for the subsequent analysis. Documenting corrective actions in CAPA ensures there is a formal record of what was done and how the issue will be addressed, supporting regulatory compliance and traceability. Conducting root cause analysis helps identify why the potency failed and what controls need to change to prevent recurrence. Dispensing the product would release non-conforming material to patients, which is unsafe and not permitted until the issue is resolved and the potency is verified again.