Question

What is the main purpose of quality assurance in GLP studies?

• A. \( \text{To work as a police force throughout studies.} \)
• B. \( \text{To work as a helping hand while performing study work.} \)
• C. \( \text{To work as a scheme to catch every mistake happening during the study.} \)
• D. \( \text{For monitoring the effectiveness of quality control program of a study.} \)

Hint:

Think of QA as the "auditor" or "checker of checks" in GLP – they make sure the quality control measures are actually working.

Answer 1

The Correct Option is D

Good Laboratory Practice (GLP) studies aim to ensure the quality, reliability, and integrity of non-clinical safety studies. Quality Assurance (QA) in GLP plays a crucial role in achieving this. The main purpose of QA is to independently monitor the conduct and reporting of studies to ensure that they are performed according to GLP principles and Standard Operating Procedures (SOPs). This involves verifying that the quality control (QC) measures are in place and are effective in ensuring the quality of the data and processes. QA is not primarily a "police force" or a system to catch every single mistake, although identifying deviations is part of their role. Their main function is to provide assurance to management and regulatory authorities that the study is being conducted with the required level of quality and integrity through systematic and independent oversight of the QC system.