CRAP Compliance Monitoring & Auditing 4

Question 1

Under FDA's 21 CFR Part 11, which of the following electronic records practices is required for GMP compliance?

Accepted Answer

Audit trails must be computer-generated, time-stamped, and protected from alteration

Answer

21 CFR Part 11 requires computer-generated, time-stamped audit trails that capture creation, modification, and deletion of GMP electronic records.

Question 2

A regulatory affairs professional is reviewing a third-party contract manufacturer (CMO). Which document most comprehensively defines the quality responsibilities between the two parties?

Accepted Answer

Quality Technical Agreement (QTA)

Answer

The Quality Technical Agreement (QTA) formally delineates GMP responsibilities, including change control, deviations, and batch release, between the sponsor and CMO.

Question 3

During a supplier audit, you find that the vendor's SOP for equipment cleaning has not been reviewed or revised in 8 years. This is primarily a concern related to:

Accepted Answer

Document control and periodic review failure

Answer

GMP regulations require periodic review of SOPs to ensure they reflect current practices; failure to review represents a document control deficiency.

Question 4

An FDA Warning Letter cites repeated failure to investigate consumer complaints. Under 21 CFR Part 211, which section specifically governs complaint handling for drugs?

Accepted Answer

21 CFR 211.198

Answer

21 CFR 211.198 requires written procedures for handling drug product complaints, including investigation of all complaints involving possible product failure.

Question 5

Which statistical tool is most appropriate for monitoring a continuous manufacturing process parameter over time to detect out-of-control conditions?

Accepted Answer

Statistical Process Control (SPC) chart

Answer

SPC charts (e.g., X-bar, R-charts) are designed for real-time monitoring of process parameters to detect statistically significant shifts or trends.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Compliance Monitoring & Auditing 4