Which unit is responsible for monitoring operations that are associated with the GLP quality system?

• A. The Quality Assurance Unit (QAU)
• B. The Marketing Unit
• C. The Procurement Unit
• D. The Human Resources Unit

Answer: (A)

In GLP work, quality assurance provides the independent monitoring that keeps the GLP quality system honest and functioning. The QA unit observes and checks how studies are planned, conducted, recorded, and reported, ensuring adherence to protocol, SOPs, and regulatory requirements. It conducts audits and inspections of facilities, equipment, procedures, and records, verifies data integrity and traceability, and follows up on any deviations with documented investigations and corrective actions. This ongoing, independent oversight helps prevent conflicts of interest and maintains the credibility of the study results. Other units like Marketing, Procurement, and Human Resources handle promotion, purchasing, and personnel matters, not GLP study monitoring.