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

510(k) premarket notification for Class I devices only

Answer

Biologics License Application for marketing only, not IND stage

Answer

GRAS (Generally Recognized as Safe) self-affirmation only

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

A full copy of all raw data from each study

Answer

A signed QAU statement for each study

Answer

A facility inspection report from the FDA

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's Center for Food Safety and Applied Nutrition (CFSAN)

Answer

FDA's Center for Veterinary Medicine (CVM) for all human studies

Answer

FDA's Office of Regulatory Affairs alone

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

The facility is immediately shut down pending correction

Answer

All ongoing studies at the facility are automatically invalidated

Answer

The FDA requires the sponsor to repeat all affected studies

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

Issuance of a Form 483 with one observation

Answer

A telephone inquiry from the FDA inspector

Answer

An informal email requesting clarification of procedures

Question 6

Under 21 CFR Part 58, which action may the FDA take when a nonclinical study is found to not have been conducted in accordance with GLP?

Accepted Answer

Disqualify the data from the study for consideration in the support of any application for a research or marketing permit

Answer

Automatically reject the entire NDA

Answer

Impose criminal penalties on all laboratory personnel

Answer

Require all studies at the facility to be repeated under FDA supervision