CRAP Compliance Monitoring & Auditing 2

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:

Accepted Answer

A data integrity violation

Answer

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?

Accepted Answer

First-party (internal) audit

Answer

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?

Accepted Answer

30 days

Answer

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?

Accepted Answer

Escalate to senior management and revise the CAPA with root cause re-analysis

Answer

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?

Accepted Answer

CAPA closure record

Answer

The CAPA closure record formally documents that the corrective action was implemented and verified as effective, enabling process or product release to proceed.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Compliance Monitoring & Auditing 2