CRAP Compliance Monitoring & Auditing 3 — Questions and Answers
Question 1: Which of the following is the primary purpose of a risk-based audit frequency model in pharmaceutical compliance?
- To reduce audit staff workload
- To allocate audit resources proportionally to the compliance risk of each area (Correct answer)
- To meet FDA's minimum audit schedule requirements
- To ensure all departments are audited equally each year
Correct 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.
Question 2: 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:
- Immediate supplier disqualification
- A change control evaluation and potential regulatory submission (Correct answer)
- An internal deviation report only
- A supplier corrective action request (SCAR) with no further action
Correct 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.
Question 3: During a mock FDA inspection, an employee is asked a question they cannot answer. The best practice is to:
- Provide a best-guess answer to appear knowledgeable
- Direct the inspector to the SME and follow up with verified information (Correct answer)
- Refer all questions to the quality director
- Decline to answer and request the question in writing
Correct 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.
Question 4: In the context of environmental monitoring in aseptic manufacturing, which metric is most useful for trending compliance performance over time?
- Total particulate counts per batch
- Action and alert level exceedance rates by location (Correct answer)
- Number of environmental samples collected
- Cost per environmental monitoring sample
Correct 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.
Question 5: What is the primary distinction between a 'critical' and a 'major' audit observation under EU GMP guidelines (EMA Annex)?
- Critical observations always result in import bans; major observations do not
- Critical observations pose an immediate risk to patient safety or data integrity; major observations indicate significant non-compliance without immediate risk (Correct answer)
- Major observations require CAPA; critical observations require regulatory reporting
- Critical observations apply only to sterile products
Correct 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.
Question 6: 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?
- Reject all batches manufactured on that day
- Initiate an investigation to determine root cause before making a batch disposition decision (Correct answer)
- Immediately notify the FDA
- Recalibrate the conductivity sensor and continue manufacturing
Correct 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.
Question 7: Which of the following best describes the role of a Quality Management Review (QMR) in a pharmaceutical compliance program?
- A batch-level review of manufacturing records
- A periodic senior management review of quality system performance metrics to drive continual improvement (Correct answer)
- A pre-approval inspection checklist
- An annual audit of the quality department only
Correct 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.
CRAP Compliance Monitoring & Auditing 3
Which of the following is the primary purpose of a risk-based audit frequency model in pharmaceutical compliance?