Compliance Monitoring & Auditing Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compliance Monitoring & Auditing flashcards as text
A regulatory affairs team is preparing for a pre-approval inspection (PAI). Which area is FDA most likely to focus on during a PAI for a new drug application?
Answer: Consistency between the approved NDA and actual manufacturing process
PAIs verify that the manufacturing process, controls, and data described in the NDA are consistent with actual facility practices before product approval.
What is the significance of the 'closing meeting' at the end of a GMP audit?
Answer: It is when findings are communicated to auditee management to allow for initial response and clarification
The closing meeting provides an opportunity to communicate audit observations to site management, allow factual corrections, and discuss preliminary findings before the formal report.
Under ICH Q9 (Quality Risk Management), which tool uses a structured team approach to identify failure modes, their effects, and their likelihood before they occur?
Answer: Failure Mode and Effects Analysis (FMEA)
FMEA is a prospective risk assessment tool that systematically identifies potential failure modes, their effects, and severity to prioritize risk reduction activities.
A compliance auditor notes that out-of-specification (OOS) investigations are consistently concluding 'laboratory error' without assignable cause documentation. This pattern most likely indicates:
Answer: Potential manipulation of OOS results to avoid manufacturing investigations
A pattern of OOS results attributed to undocumented laboratory error without assignable cause suggests potential data integrity issues or inadequate OOS investigation procedures.
Which document would a regulatory affairs professional consult to determine the specific GMP requirements applicable to the manufacture of APIs for use in human drugs?
Answer: ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)
ICH Q7 provides GMP guidance specific to the manufacturing of APIs for use in human medicinal products and has been adopted by FDA, EMA, and other major agencies.
A compliance team discovers that change control records for a validated cleaning process were not created when the detergent concentration was altered six months ago. This is most accurately described as:
Answer: An unauthorized change that may invalidate the cleaning validation
Altering a validated process parameter without change control can invalidate the validation and constitutes an unauthorized change requiring retrospective assessment.
Under the FDA Voluntary Action Indicated (VAI) classification, what does this outcome mean for the inspected facility?
Answer: Objectionable conditions were found but FDA does not require regulatory action at this time
VAI indicates that FDA found some objectionable conditions but determined that regulatory action is not warranted; the facility should still address findings voluntarily.