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

Food additive safety studies

Answer

Medical device clinical trials

Answer

Drug bioavailability studies

Question 2

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

Accepted Answer

A Quality Assurance Statement

Answer

A sponsor sign-off letter

Answer

A facility inspection certificate

Answer

An IRB approval letter

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

Amendment

Answer

Protocol deviation

Answer

Signed annotation

Question 4

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

Accepted Answer

Protocol

Answer

Standard Operating Procedure

Answer

Master Schedule Sheet

Answer

Study Report

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

To list all SOPs currently in use

Answer

To document animal care procedures

Answer

To record equipment calibration dates

Question 6

Which GLP requirement mandates that laboratory equipment be periodically inspected, cleaned, and maintained?

Accepted Answer

Equipment calibration and maintenance requirements under 21 CFR 58.63

Answer

21 CFR Part 11 electronic records rule

Answer

ISO 9001 preventive maintenance clause

Answer

EPA RCRA equipment standards