SQA Regulatory Submissions and Compliance 2

Question 1

What is the purpose of the OECD Test Guidelines Programme in the context of GLP?

Accepted Answer

To provide internationally harmonized methods for conducting nonclinical safety tests accepted by all OECD member countries

Answer

To replace GLP regulations in all OECD countries

Answer

To set maximum residue limits for pesticides in food

Answer

To establish clinical trial design standards

Question 2

Which element is required in a GLP compliance statement submitted with a regulatory application?

Accepted Answer

A statement that the study was conducted in accordance with GLP regulations, signed by the Study Director

Answer

Signature of the FDA reviewer

Answer

Sponsor's financial disclosure statement

Answer

IRB approval documentation

Question 3

Under the OECD Principles of GLP, which document must be referenced when a nonclinical safety study uses an OECD Test Guideline method?

Accepted Answer

The specific OECD Test Guideline number and version must be cited in the protocol and final report

Answer

Only the sponsor's internal SOP for the method needs to be cited

Answer

No citation is required if the method is widely known

Answer

The original literature source for the method must be cited instead of the OECD guideline

Question 4

What is the significance of the OECD Mutual Acceptance of Data (MAD) framework for US sponsors submitting studies internationally?

Accepted Answer

Studies conducted under GLP in one OECD member country are accepted by other member countries, eliminating the need to duplicate studies

Answer

US GLP studies are automatically accepted by all countries globally, not just OECD members

Answer

MAD applies only to agricultural chemical safety studies, not pharmaceutical studies

Answer

MAD requires re-inspection of the test facility by each receiving country's regulatory agency

Question 5

Which FDA guidance document provides the agency's current thinking on GLP regulations for nonclinical laboratory studies?

Accepted Answer

FDA's Bioresearch Monitoring compliance program guidance manuals for GLP inspections

Answer

ICH E6(R2) Good Clinical Practice guideline

Answer

FDA's 21 CFR Part 11 electronic records guidance

Answer

FDA's process validation guidance for pharmaceutical manufacturing

Question 6

When a GLP study is conducted at multiple test sites (multisite study), what additional GLP requirements apply?

Accepted Answer

Each site must have a Principal Investigator, the Study Director retains overall responsibility, and each site's activities must be covered by the protocol

Answer

Each site must have its own Study Director

Answer

A separate QAU must be established at each site independently

Answer

The sponsor must conduct GLP inspections at each site before the study begins