GLP Regulations and Compliance Flashcards

Which federal regulation governs Good Laboratory Practice (GLP) standards for nonclinical laboratory studies submitted to the FDA?

Answer: 21 CFR Part 58

21 CFR Part 58 establishes the FDA's GLP regulations for nonclinical laboratory studies.

Under GLP regulations, who is primarily responsible for ensuring the study is conducted in accordance with the protocol?

Answer: Study Director

The Study Director is the single point of study control and bears primary responsibility for protocol compliance.

What is the minimum retention period for raw data and specimens under FDA GLP regulations?

Answer: 2 years after the date the application is approved

Under 21 CFR Part 58, raw data must be retained for at least 2 years after the date the application is approved or until 5 years after the study is completed if no application is filed.

Which OECD Principles of GLP document serves as the international equivalent standard for nonclinical safety studies?

Answer: OECD Series on Principles of GLP No. 1

The OECD Series on Principles of GLP No. 1 is the internationally recognized GLP standard adopted by OECD member countries.

Under GLP, a protocol amendment must be signed by which individual before implementation?

Answer: Study Director

Protocol amendments must be authorized by the Study Director's signature before they are implemented.

Which statement correctly describes the role of the Quality Assurance Unit (QAU) under GLP regulations?

Answer: The QAU monitors studies and inspects facilities but does not direct the conduct of studies

The QAU performs monitoring, facility inspections, and reporting functions while remaining independent from study conduct.