CRAP Compliance Monitoring & Auditing 2 — Questions and Answers
Question 1: During a GMP audit, an investigator finds a batch record with a correction made without an adjacent signature and date. This is best classified as:
- A critical observation requiring immediate CAPA
- A data integrity violation (Correct answer)
- An acceptable practice if initialed elsewhere on the page
- A minor finding requiring no action
Correct answer: A data integrity violation
Unsigned, undated corrections to batch records constitute a data integrity violation under ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
Question 2: Which audit type is conducted by a firm on its own operations to identify deficiencies before a regulatory inspection?
- Second-party audit
- Third-party audit
- First-party (internal) audit (Correct answer)
- For-cause audit
Correct answer: First-party (internal) audit
A first-party or internal audit is self-initiated by the organization to proactively identify compliance gaps.
Question 3: A pharmaceutical manufacturer receives an FDA Form 483 with three observations. What is the appropriate initial response timeframe?
- 30 days (Correct answer)
- 45 days
- 60 days
- 15 business days
Correct answer: 30 days
FDA expects a written response to Form 483 observations within 15 business days (approximately 21 calendar days), but industry convention often targets 30 calendar days.
Question 4: A Corrective and Preventive Action (CAPA) plan is deemed ineffective during a follow-up audit. What should happen next?
- Close the CAPA and open a new deviation report
- Escalate to senior management and revise the CAPA with root cause re-analysis (Correct answer)
- Accept the CAPA as partially effective
- Notify the FDA immediately
Correct answer: Escalate to senior management and revise the CAPA with root cause re-analysis
An ineffective CAPA requires escalation, root cause re-analysis, and revision of the corrective measures to address the underlying issue.
Question 5: Under 21 CFR Part 820 (Quality System Regulation), which document formally grants approval for a product or process to proceed after an audit finding is resolved?
- Design History File
- Device Master Record
- CAPA closure record (Correct answer)
- Product release certificate
Correct answer: CAPA closure record
The CAPA closure record formally documents that the corrective action was implemented and verified as effective, enabling process or product release to proceed.
Question 6: An audit team discovers that supplier qualification records are incomplete for 40% of critical raw material vendors. This is most appropriately classified as:
- Minor observation
- Major observation (Correct answer)
- Critical observation
- Informational finding
Correct answer: Major observation
Incomplete supplier qualification for a significant portion of critical vendors represents a systemic major observation, indicating a breakdown in the quality system.
Question 7: Which regulatory framework specifically requires pharmaceutical manufacturers to conduct periodic product quality reviews (PQRs) or annual product reviews (APRs)?
- ICH Q7
- 21 CFR Part 211.180(e) (Correct answer)
- ICH Q10
- 21 CFR Part 820.100
Correct answer: 21 CFR Part 211.180(e)
21 CFR Part 211.180(e) requires annual product reviews for drug products to assess quality standards and the need for changes.
CRAP Compliance Monitoring & Auditing 2
During a GMP audit, an investigator finds a batch record with a correction made without an adjacent signature and date.
This is best classified as: