When a potency test for a compound in production is out of specification, which action should NOT be performed?

• A. Dispense the product
• B. Immediately quarantine the product
• C. Perform a root cause analysis to investigate why the issue occurred
• D. Document corrective and preventative actions in a CAPA report

Answer: (A)

Potency must meet specification before any product is released. If potency is out of specification during production, the immediate step is to quarantine the affected material to prevent its distribution. Dispensing the product would allow a subpotent or inconsistent product to reach patients, which is unsafe and violates regulatory requirements. After quarantine, conduct a root cause analysis to identify why potency deviated—factors could include process variation, raw material quality, equipment calibration, or an analytical method issue. Then implement corrective and preventive actions (CAPA) to address the root cause and strengthen the system, and document all findings and actions in CAPA records. The final disposition of the quarantined material should follow the investigation and CAPA outcomes, which may include retesting, rework, or disposal.