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
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:
Answer: A data integrity violation
Unsigned, undated corrections to batch records constitute a data integrity violation under ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
Which audit type is conducted by a firm on its own operations to identify deficiencies before a regulatory inspection?
Answer: First-party (internal) audit
A first-party or internal audit is self-initiated by the organization to proactively identify compliance gaps.
A pharmaceutical manufacturer receives an FDA Form 483 with three observations. What is the appropriate initial response timeframe?
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.
A Corrective and Preventive Action (CAPA) plan is deemed ineffective during a follow-up audit. What should happen next?
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.
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?
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.
An audit team discovers that supplier qualification records are incomplete for 40% of critical raw material vendors. This is most appropriately classified as:
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.
Which regulatory framework specifically requires pharmaceutical manufacturers to conduct periodic product quality reviews (PQRs) or annual product reviews (APRs)?
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.