SQA GLP Regulations and Compliance 1 — Questions and Answers
Question 1: Which federal regulation governs Good Laboratory Practice (GLP) standards for nonclinical laboratory studies submitted to the FDA?
- 21 CFR Part 58 (Correct answer)
- 21 CFR Part 11
- 21 CFR Part 820
- 21 CFR Part 210
Correct answer: 21 CFR Part 58
21 CFR Part 58 establishes the FDA's GLP regulations for nonclinical laboratory studies.
Question 2: Under GLP regulations, who is primarily responsible for ensuring the study is conducted in accordance with the protocol?
- Study Director (Correct answer)
- Quality Assurance Unit
- Sponsor
- Test Facility Management
Correct answer: Study Director
The Study Director is the single point of study control and bears primary responsibility for protocol compliance.
Question 3: What is the minimum retention period for raw data and specimens under FDA GLP regulations?
- 2 years after the date the application is approved (Correct answer)
- 5 years from study completion
- 10 years from study initiation
- Until the sponsor requests destruction
Correct 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.
Question 4: Which OECD Principles of GLP document serves as the international equivalent standard for nonclinical safety studies?
- OECD Series on Principles of GLP No. 1 (Correct answer)
- ICH E6 Guideline
- ISO 17025
- EPA FIFRA GLP Standards
Correct 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.
Question 5: Under GLP, a protocol amendment must be signed by which individual before implementation?
- Study Director (Correct answer)
- Sponsor
- Quality Assurance Unit
- Test Facility Management
Correct answer: Study Director
Protocol amendments must be authorized by the Study Director's signature before they are implemented.
Question 6: Which statement correctly describes the role of the Quality Assurance Unit (QAU) under GLP regulations?
- The QAU monitors studies and inspects facilities but does not direct the conduct of studies (Correct answer)
- The QAU is responsible for designing study protocols
- The QAU approves all raw data entries
- The QAU serves as the Study Director's direct supervisor
Correct 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.
SQA GLP Regulations and Compliance 1
Which federal regulation governs Good Laboratory Practice (GLP) standards for nonclinical laboratory studies submitted to the FDA?