KAPS Regulatory Affairs and Quality Assurance 3 — Questions and Answers
Question 1: Under the Hatch-Waxman Act, what type of exclusivity is granted to the first ANDA applicant to file a Paragraph IV certification?
- 5-year new chemical entity exclusivity
- 3-year new clinical investigation exclusivity
- 180-day generic drug exclusivity (Correct answer)
- 7-year orphan drug exclusivity
Correct answer: 180-day generic drug exclusivity
The first applicant to file an ANDA with a Paragraph IV certification challenging a listed patent is awarded 180-day marketing exclusivity if successful.
Question 2: Which of the following changes to an approved NDA requires a Prior Approval Supplement (PAS) before implementation?
- A minor label change to correct a typographical error
- Addition of a new indication not included in the original approval (Correct answer)
- A change in the expiration dating period supported by new stability data
- A change in batch size within approved validated ranges
Correct answer: Addition of a new indication not included in the original approval
Adding a new indication is a major change requiring FDA approval via a PAS before the change can be implemented.
Question 3: What is the function of an Out-of-Specification (OOS) investigation in pharmaceutical QA?
- To retest samples until a passing result is obtained
- To systematically determine the root cause of a result that falls outside established specifications (Correct answer)
- To automatically reject and destroy the batch in question
- To notify the FDA of a manufacturing deviation
Correct answer: To systematically determine the root cause of a result that falls outside established specifications
OOS investigations follow a structured, two-phase approach (laboratory and full-scale investigation) to determine if the failure was caused by laboratory error or an actual manufacturing issue.
Question 4: Under ICH Q9, which risk assessment tool uses a numerical approach by multiplying Severity, Occurrence, and Detectability scores?
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Failure Mode and Effects Analysis (FMEA) (Correct answer)
- Preliminary Hazard Analysis (PHA)
Correct answer: Failure Mode and Effects Analysis (FMEA)
FMEA calculates a Risk Priority Number (RPN) by multiplying Severity × Occurrence × Detectability to prioritize risk mitigation efforts.
Question 5: Which section of the Common Technical Document (CTD) contains the clinical study reports?
- Module 2
- Module 3
- Module 4
- Module 5 (Correct answer)
Correct answer: Module 5
Module 5 of the CTD contains clinical study reports, including pharmacokinetic studies, clinical pharmacology, and controlled clinical trials.
Question 6: A stability study conducted at 40°C/75% RH for 6 months is classified as which type of stability testing per ICH Q1A?
- Long-term stability testing
- Intermediate stability testing
- Accelerated stability testing (Correct answer)
- Stress testing
Correct answer: Accelerated stability testing
ICH Q1A defines 40°C ± 2°C / 75% RH ± 5% RH as the accelerated storage condition for products intended for storage below 25°C.
Question 7: Under 21 CFR Part 803, a manufacturer of a marketed device must submit a Medical Device Report (MDR) within how many days of becoming aware of a malfunction that could cause serious injury?
- 5 days
- 15 days
- 30 days (Correct answer)
- 45 days
Correct answer: 30 days
21 CFR 803.50 requires device manufacturers to submit a 30-day MDR for malfunctions that could cause or contribute to serious injury if the malfunction were to recur.
KAPS Regulatory Affairs and Quality Assurance 3
Under the Hatch-Waxman Act, what type of exclusivity is granted to the first ANDA applicant to file a Paragraph IV certification?