KAPS Regulatory Affairs and Quality Assurance 3

Question 1

Under the Hatch-Waxman Act, what type of exclusivity is granted to the first ANDA applicant to file a Paragraph IV certification?

Accepted Answer

180-day generic drug exclusivity

Answer

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?

Accepted Answer

Addition of a new indication not included in the original approval

Answer

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?

Accepted Answer

To systematically determine the root cause of a result that falls outside established specifications

Answer

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?

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

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?

Accepted Answer

Module 5

Answer

Module 5 of the CTD contains clinical study reports, including pharmacokinetic studies, clinical pharmacology, and controlled clinical trials.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Regulatory Affairs and Quality Assurance 3