SQA GLP Regulations and Compliance 2

Question 1

What does the EPA's GLP standard under TSCA (40 CFR Part 792) primarily apply to?

Accepted Answer

Health and environmental effects studies submitted under TSCA

Answer

40 CFR Part 792 applies to nonclinical health and environmental effects studies submitted to the EPA under the Toxic Substances Control Act.

Question 2

Under GLP regulations, what must accompany each final study report to certify compliance?

Accepted Answer

A Quality Assurance Statement

Answer

A Quality Assurance Statement signed by the QAU must be included in the final report to document compliance inspections.

Question 3

Which term describes a written record that permanently documents a change or correction to raw data under GLP?

Accepted Answer

Audit trail

Answer

An audit trail is the GLP-required record showing who made a change to raw data, when, and why.

Question 4

Under GLP, which document provides the overall plan for a nonclinical study including objectives and methods?

Accepted Answer

Protocol

Answer

The protocol is the formal document that outlines the study's purpose, design, methods, and statistical analysis plan.

Question 5

What is the purpose of the Master Schedule Sheet in a GLP-compliant facility?

Accepted Answer

To provide an inventory of all studies conducted at the facility

Answer

The Master Schedule Sheet is a summary of all studies conducted at the test facility, used to assess workload and track study status.

SQA - Society of Quality Assurance Practice Test