What is the first action when a batch has a suspicious quality problem?

• A. Quarantine the batch
• B. Immediately release to stock
• C. Re-label and distribute
• D. Discard immediately

Answer: (A)

When a batch shows a suspicious quality problem, the priority is to prevent any use or distribution until the issue is understood. Quarantining the batch achieves this by isolating it from all inventory, so it cannot be released to stock or dispatched to customers. This preserves material for investigation, maintains traceability, and allows QA to review the problem, collect samples, perform tests, and determine the proper disposition. Releasing to stock would risk patient safety, and re-labeling and distributing would hide the problem and violate regulatory controls. Discarding immediately might be wasteful or inappropriate without a formal disposition from QA after investigation. The quarantine step buys time to correctly assess and manage the issue.