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
Which of the following is the primary purpose of a risk-based audit frequency model in pharmaceutical compliance?
Answer: To allocate audit resources proportionally to the compliance risk of each area
Risk-based audit frequency ensures that higher-risk processes and suppliers receive more frequent scrutiny, optimizing resource allocation.
A supplier of a critical API is audited and found to use a process not described in the Drug Master File (DMF). This finding should trigger:
Answer: A change control evaluation and potential regulatory submission
Undisclosed process changes to a registered API process may require a regulatory filing (e.g., CBE, PAS) and must be evaluated through change control.
During a mock FDA inspection, an employee is asked a question they cannot answer. The best practice is to:
Answer: Direct the inspector to the SME and follow up with verified information
Employees should never guess; they should direct inspectors to the appropriate subject matter expert and provide accurate, verified responses.
In the context of environmental monitoring in aseptic manufacturing, which metric is most useful for trending compliance performance over time?
Answer: Action and alert level exceedance rates by location
Trending action and alert level exceedance rates by location identifies patterns of contamination risk and measures the effectiveness of controls.
What is the primary distinction between a 'critical' and a 'major' audit observation under EU GMP guidelines (EMA Annex)?
Answer: Critical observations pose an immediate risk to patient safety or data integrity; major observations indicate significant non-compliance without immediate risk
Under EU GMP, critical observations indicate immediate risk to patient safety or data integrity, while major observations reflect significant GMP failures without immediate risk.
A compliance monitoring program detects a deviation in water system conductivity that exceeds the alert limit. Which action is MOST appropriate as a first step?
Answer: Initiate an investigation to determine root cause before making a batch disposition decision
Alert limit exceedances require investigation to determine cause and impact before any batch disposition decision can be made.
Which of the following best describes the role of a Quality Management Review (QMR) in a pharmaceutical compliance program?
Answer: A periodic senior management review of quality system performance metrics to drive continual improvement
QMR is a scheduled senior management review of quality system metrics, trends, and resources to ensure the QMS remains effective and drives improvement.