Quality assurance is process-oriented, aiming to prevent defects by improving the development and production processes. Quality control is product-oriented, focusing on identifying defects in the final product through testing and inspection. Because QA works to prevent problems by refining how things are made, while QC checks the actual product for defects, the correct pairing assigns the defects-detection role toQuality Control and the process-improvement role to Quality Assurance. The other option would swap these roles, which doesn’t fit how these concepts are defined.

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.

Full-face respirators are used when there is a real risk of exposure to hazardous drugs through splashes or aerosols, providing both eye protection and a seal around the entire face to protect the respiratory tract. This is crucial during deep cleaning of the C-PEC, when residues can become airborne, during spills larger than what the spill kit can handle, or whenever splashes could occur. In these situations, protecting both eyes and breathing is essential because exposure can happen through inhalation or ocular contact, and standard eye protection alone would not prevent inhalation of hazardous drug aerosols. They are not required for routine handling outside the C-PEC, where less intensive protection is typically adequate, and they are not unnecessary for spill cleanups; the need for respiratory protection rises when the spill is large or splashes are anticipated.

Exact product identity and lot-number traceability are being tested. The only option that has both the correct product and the exact lot number is Product XYABA 2% with Lot# 0101202225. The other choices fail because they either change the product name (XYABAA), the strength (1% instead of 2%), or provide an incorrect lot number (different digits or format). Using the exact combination is essential for accurate identification, traceability, and safety in handling and recalls.