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
Under FDA's 21 CFR Part 11, which of the following electronic records practices is required for GMP compliance?
Answer: Audit trails must be computer-generated, time-stamped, and protected from alteration
21 CFR Part 11 requires computer-generated, time-stamped audit trails that capture creation, modification, and deletion of GMP electronic records.
A regulatory affairs professional is reviewing a third-party contract manufacturer (CMO). Which document most comprehensively defines the quality responsibilities between the two parties?
Answer: Quality Technical Agreement (QTA)
The Quality Technical Agreement (QTA) formally delineates GMP responsibilities, including change control, deviations, and batch release, between the sponsor and CMO.
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:
Answer: Document control and periodic review failure
GMP regulations require periodic review of SOPs to ensure they reflect current practices; failure to review represents a document control deficiency.
An FDA Warning Letter cites repeated failure to investigate consumer complaints. Under 21 CFR Part 211, which section specifically governs complaint handling for drugs?
Answer: 21 CFR 211.198
21 CFR 211.198 requires written procedures for handling drug product complaints, including investigation of all complaints involving possible product failure.
Which statistical tool is most appropriate for monitoring a continuous manufacturing process parameter over time to detect out-of-control conditions?
Answer: Statistical Process Control (SPC) chart
SPC charts (e.g., X-bar, R-charts) are designed for real-time monitoring of process parameters to detect statistically significant shifts or trends.
A medical device company uses a software tool to manage nonconformances. Under 21 CFR Part 820, the software validation status of this tool must be:
Answer: Validated regardless of whether it is commercial off-the-shelf (COTS) or custom
Under 21 CFR Part 820.70(i), software used as part of the quality system must be validated for its intended use, regardless of whether it is COTS or custom.
A compliance audit reveals that employees are trained on SOPs after performing the tasks rather than before. This is classified as a deficiency because:
Answer: GMP requires personnel to be trained prior to performing regulated activities
GMP regulations require that personnel be trained before performing GMP-related tasks to ensure they understand requirements prior to execution.