SQA GLP Regulations and Compliance

Question 1

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

Accepted Answer

21 CFR Part 58

Answer

21 CFR Part 11

Answer

21 CFR Part 820

Answer

21 CFR Part 210

Question 2

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

Accepted Answer

Study Director

Answer

Quality Assurance Unit

Answer

Sponsor

Answer

Test Facility Management

Question 3

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

Accepted Answer

2 years after the date the application is approved

Answer

5 years from study completion

Answer

10 years from study initiation

Answer

Until the sponsor requests destruction

Question 4

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

Accepted Answer

OECD Series on Principles of GLP No. 1

Answer

ICH E6 Guideline

Answer

ISO 17025

Answer

EPA FIFRA GLP Standards

Question 5

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

Accepted Answer

Study Director

Answer

Sponsor

Answer

Quality Assurance Unit

Answer

Test Facility Management

Question 6

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

Accepted Answer

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

Answer

The QAU is responsible for designing study protocols

Answer

The QAU approves all raw data entries

Answer

The QAU serves as the Study Director's direct supervisor