After a potency test shows out-of-spec results, which action should be taken?

• A. Dispense the product
• B. Quarantine the product
• C. Continue production
• D. Consult the supplier

Answer: (B)

Out-of-spec potency means the product doesn’t meet the required specification, so the top priority is to prevent any potentially unsafe or ineffective material from reaching patients. Quarantining the affected inventory isolates it in a controlled area, preserving traceability and signaling quality assurance to conduct the formal disposition process (retesting, rework, return to supplier, or disposal) based on investigation results. This approach protects patients, maintains regulatory compliance, and enables a proper root-cause analysis without spreading the problem. Dispensing the product would risk patient safety, continuing production would propagate the issue, and while consulting the supplier is part of the investigation, it doesn’t address immediate risk on its own.