SQA Regulatory Submissions and Compliance 1 — Questions and Answers
Question 1: Which regulatory submission to the FDA requires GLP-compliant nonclinical safety data as a prerequisite for approval?
- New Drug Application (NDA) and Investigational New Drug Application (IND) (Correct answer)
- 510(k) premarket notification for Class I devices only
- Biologics License Application for marketing only, not IND stage
- GRAS (Generally Recognized as Safe) self-affirmation only
Correct answer: New Drug Application (NDA) and Investigational New Drug Application (IND)
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?
- A statement indicating whether each study was conducted in compliance with GLP and an explanation if not (Correct answer)
- A full copy of all raw data from each study
- A signed QAU statement for each study
- A facility inspection report from the FDA
Correct answer: A statement indicating whether each study was conducted in compliance with GLP and an explanation if not
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?
- FDA's Bioresearch Monitoring (BIMO) program within CDER and CBER (Correct answer)
- FDA's Center for Food Safety and Applied Nutrition (CFSAN)
- FDA's Center for Veterinary Medicine (CVM) for all human studies
- FDA's Office of Regulatory Affairs alone
Correct answer: FDA's Bioresearch Monitoring (BIMO) program within CDER and CBER
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?
- The form lists inspectional observations that must be addressed by the facility with a written response (Correct answer)
- The facility is immediately shut down pending correction
- All ongoing studies at the facility are automatically invalidated
- The FDA requires the sponsor to repeat all affected studies
Correct answer: The form lists inspectional observations that must be addressed by the facility with a written response
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?
- Issuance of a Warning Letter citing GLP violations (Correct answer)
- Issuance of a Form 483 with one observation
- A telephone inquiry from the FDA inspector
- An informal email requesting clarification of procedures
Correct answer: Issuance of a Warning Letter citing GLP violations
An FDA Warning Letter is the most serious pre-legal enforcement action, indicating significant GLP violations requiring immediate correction.
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?
- Disqualify the data from the study for consideration in the support of any application for a research or marketing permit (Correct answer)
- Automatically reject the entire NDA
- Impose criminal penalties on all laboratory personnel
- Require all studies at the facility to be repeated under FDA supervision
Correct answer: Disqualify the data from the study for consideration in the support of any application for a research or marketing permit
Non-GLP compliant study data may be disqualified for regulatory consideration, meaning it cannot be used to support applications.
SQA Regulatory Submissions and Compliance 1
Which regulatory submission to the FDA requires GLP-compliant nonclinical safety data as a prerequisite for approval?