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
Under the Prescription Drug User Fee Act (PDUFA), what is the review timeline goal for a Priority Review NDA?
Answer: 6 months
Priority Review designation sets a PDUFA goal of 6 months from the date of filing, compared to 10 months for standard review applications.
What does a Qualified Person (QP) certification signify in EU pharmaceutical regulations?
Answer: The QP certifies that each batch has been manufactured, controlled, and released in compliance with EU GMP and marketing authorization requirements
Under EU Directive 2001/83/EC, a Qualified Person must certify that each batch of a medicinal product has been manufactured and checked in compliance with applicable law before it is released to the market.
Which of the following correctly describes the role of the Pharmaceutical Inspection Co-operation Scheme (PIC/S)?
Answer: A non-binding cooperative arrangement among drug regulatory authorities to harmonize GMP standards and inspections
PIC/S is a non-binding cooperative arrangement between regulatory authorities that facilitates the harmonization of GMP standards, inspection procedures, and inspector training worldwide.
A pharmaceutical manufacturer discovers a potential safety issue with a marketed product. Under 21 CFR Part 7, which recall classification indicates the most serious health hazard?
Answer: Class I
Class I recall is the most serious category, indicating that use of or exposure to the violative product will cause serious adverse health consequences or death.
In pharmaceutical stability testing, what is the purpose of a 'bracketing' design?
Answer: Testing only the extreme samples of design factors (e.g., lowest and highest strengths, smallest and largest container sizes) on the assumption that intermediates are represented
Bracketing, per ICH Q1D, is a design where only the extremes of certain design factors are tested, with the assumption that results represent all intermediate levels.
Which FDA database or system is used by manufacturers to submit electronic adverse event reports for marketed drugs under the MedWatch program?
Answer: FDA Adverse Event Reporting System (FAERS)
FAERS (FDA Adverse Event Reporting System) is the database that receives and stores adverse event reports submitted by manufacturers, healthcare professionals, and consumers for marketed drugs and biologics.
Under ICH Q10, what are the four main elements of the Pharmaceutical Quality System (PQS)?
Answer: Process performance and product quality monitoring, CAPA, change management, and management review
ICH Q10 identifies four PQS elements: process performance and product quality monitoring system, CAPA system, change management system, and management review of process performance and product quality.