SQA GLP Regulations and Compliance 1

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 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?

Accepted Answer

Study Director

Answer

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?

Accepted Answer

2 years after the date the application is approved

Answer

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?

Accepted Answer

OECD Series on Principles of GLP No. 1

Answer

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?

Accepted Answer

Study Director

Answer

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

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA GLP Regulations and Compliance 1