SQA Regulatory Submissions and Compliance 3

Question 1

What is the role of a 'Monitoring Authority' in the OECD GLP framework?

Accepted Answer

A national authority responsible for inspecting test facilities to verify GLP compliance within that country

Answer

Under OECD GLP, the Monitoring Authority is the national regulatory body (e.g., FDA in the US) that inspects test facilities to verify compliance.

Question 2

Which section of an NDA requires a summary of all GLP nonclinical pharmacology and toxicology studies?

Accepted Answer

Module 4: Nonclinical Study Reports (CTD format)

Answer

In the Common Technical Document (CTD) format, Module 4 contains all nonclinical study reports including GLP toxicology data.

Question 3

What does a 'Data Audit' by a regulatory agency such as the FDA typically involve during a GLP inspection?

Accepted Answer

Comparing raw data to reported results in the final study report to verify accuracy and completeness

Answer

Regulatory data audits trace data from original raw records to final reported values, verifying accuracy and detecting fabrication or manipulation.

Question 4

Under US GLP regulations, which agency has GLP oversight authority for pesticide studies submitted under FIFRA?

Accepted Answer

U.S. Environmental Protection Agency (EPA)

Answer

The EPA has GLP regulatory authority over nonclinical studies submitted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Question 5

What is the purpose of a 'Compliance Status Letter' issued by an OECD Monitoring Authority to a GLP test facility?

Accepted Answer

To certify that the test facility has been inspected and found to operate in compliance with GLP Principles

Answer

Compliance Status Letters certify that a facility has undergone inspection and been found compliant with OECD GLP Principles, supporting mutual recognition of study data.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Regulatory Submissions and Compliance 3