Practice Test Geeks(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test
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Regulatory Affairs and Quality Assurance Flashcards

7 cards from real KAPS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Regulatory Affairs and Quality Assurance flashcards as text

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

    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.

  2. Which of the following changes to an approved NDA requires a Prior Approval Supplement (PAS) before implementation?

    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.

  3. What is the function of an Out-of-Specification (OOS) investigation in pharmaceutical QA?

    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.

  4. Under ICH Q9, which risk assessment tool uses a numerical approach by multiplying Severity, Occurrence, and Detectability scores?

    Answer: Failure Mode and Effects Analysis (FMEA)

    FMEA calculates a Risk Priority Number (RPN) by multiplying Severity × Occurrence × Detectability to prioritize risk mitigation efforts.

  5. Which section of the Common Technical Document (CTD) contains the clinical study reports?

    Answer: Module 5

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

  6. A stability study conducted at 40°C/75% RH for 6 months is classified as which type of stability testing per ICH Q1A?

    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.

  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?

    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.