How does GLP regulate the number of QA inspections required for a study?

• A. Inspections must be adequate and of sufficient number to ensure study integrity
• B. Inspections must be performed daily
• C. There is a fixed number of inspections per study
• D. QA inspections are optional and not required for most studies

Answer: (A)

Under GLP, the role of QA is to monitor all aspects of the study to protect data integrity and reliability. The number and scope of QA inspections must be adequate to detect deviations and ensure that the study is conducted, recorded, and reported in compliance with GLP. Since studies vary in complexity, risk, and criticality, there isn’t a universal fixed number of inspections. Instead, a risk‑based QA plan guides how often and how thoroughly inspections occur, ensuring timely identification of issues and prompt corrective actions. Inspections cover facilities, equipment, personnel adherence to SOPs, and the accuracy and completeness of records and data, reinforcing that the study’s results are trustworthy. Optional inspections or a rigid daily schedule would not reliably safeguard integrity, whereas having enough inspections to address the specific risks of a study ensures its credibility.