SQA GLP Regulations and Compliance 2 — Questions and Answers
Question 1: What does the EPA's GLP standard under TSCA (40 CFR Part 792) primarily apply to?
- Health and environmental effects studies submitted under TSCA (Correct answer)
- Food additive safety studies
- Medical device clinical trials
- Drug bioavailability studies
Correct answer: Health and environmental effects studies submitted under TSCA
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?
- A Quality Assurance Statement (Correct answer)
- A sponsor sign-off letter
- A facility inspection certificate
- An IRB approval letter
Correct answer: A Quality Assurance Statement
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?
- Amendment
- Protocol deviation
- Audit trail (Correct answer)
- Signed annotation
Correct answer: Audit trail
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?
- Protocol (Correct answer)
- Standard Operating Procedure
- Master Schedule Sheet
- Study Report
Correct answer: Protocol
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?
- To provide an inventory of all studies conducted at the facility (Correct answer)
- To list all SOPs currently in use
- To document animal care procedures
- To record equipment calibration dates
Correct answer: To provide an inventory of all studies conducted at the facility
The Master Schedule Sheet is a summary of all studies conducted at the test facility, used to assess workload and track study status.
Question 6: Which GLP requirement mandates that laboratory equipment be periodically inspected, cleaned, and maintained?
- Equipment calibration and maintenance requirements under 21 CFR 58.63 (Correct answer)
- 21 CFR Part 11 electronic records rule
- ISO 9001 preventive maintenance clause
- EPA RCRA equipment standards
Correct answer: Equipment calibration and maintenance requirements under 21 CFR 58.63
21 CFR 58.63 requires that equipment used in GLP studies be adequately maintained, cleaned, and calibrated.
SQA GLP Regulations and Compliance 2
What does the EPA's GLP standard under TSCA (40 CFR Part 792) primarily apply to?