SQA Regulatory Submissions and Compliance

Question 1

Which regulatory submission to the FDA requires GLP-compliant nonclinical safety data as a prerequisite for approval?

Accepted Answer

New Drug Application (NDA) and Investigational New Drug Application (IND)

Answer

Both IND and NDA submissions require GLP-compliant nonclinical safety data to support human exposure and marketing approval.

Question 2

What must a sponsor include in an IND submission regarding GLP compliance of nonclinical studies?

Accepted Answer

A statement indicating whether each study was conducted in compliance with GLP and an explanation if not

Answer

The IND must include a statement for each nonclinical study indicating GLP compliance status and justification for any non-compliance.

Question 3

Which FDA center is responsible for issuing GLP inspection citations for pharmaceutical nonclinical studies?

Accepted Answer

FDA's Bioresearch Monitoring (BIMO) program within CDER and CBER

Answer

FDA BIMO programs within CDER and CBER conduct GLP inspections and issue citations for pharmaceutical nonclinical studies.

Question 4

What is the consequence of a GLP inspection finding that results in an FDA Form 483 issuance?

Accepted Answer

The form lists inspectional observations that must be addressed by the facility with a written response

Answer

FDA Form 483 documents inspectional observations that require a formal written response from the facility management.

Question 5

Which action by the FDA represents the most serious enforcement outcome following a GLP inspection?

Accepted Answer

Issuance of a Warning Letter citing GLP violations

Answer

An FDA Warning Letter is the most serious pre-legal enforcement action, indicating significant GLP violations requiring immediate correction.

SQA - Society of Quality Assurance Practice Test