CRAP Continuous Improvement & Updates 2

Question 1

A regulatory affairs team discovers that a competitor received a Complete Response Letter (CRL) for a similar product due to labeling deficiencies. What is the BEST continuous improvement action?

Accepted Answer

Conduct an internal gap analysis of your own labeling against the cited deficiencies

Answer

Proactive gap analysis using publicly available regulatory actions on comparable products helps prevent similar deficiencies before submission.

Question 2

Which CAPA element specifically ensures that corrective actions taken in response to a regulatory finding are verified as effective?

Accepted Answer

Effectiveness check

Answer

An effectiveness check (or effectiveness review) verifies that the implemented corrective action actually resolved the root cause and that the problem has not recurred.

Question 3

FDA issues an updated guidance document that narrows acceptable impurity thresholds for a marketed drug. Under 21 CFR Part 314, what is the manufacturer's obligation?

Accepted Answer

Assess the impact and file a Prior Approval Supplement if manufacturing changes are needed

Answer

Changes affecting product quality or specifications in an approved application generally require a supplement, with the type (PAS, CBE-30, Annual) depending on the risk level of the change.

Question 4

During a management review, a company identifies that deviations related to label reconciliation have increased 40% over six months. The MOST appropriate continuous improvement response is to:

Accepted Answer

Open a CAPA, investigate root cause, and implement systemic corrective measures

Answer

A sustained upward deviation trend requires a formal CAPA with root cause investigation and systemic corrective actions, not just retraining.

Question 5

What is the primary purpose of a post-implementation review (PIR) after a regulatory-driven process change?

Accepted Answer

To verify that the change achieved its intended outcome without introducing new risks

Answer

A PIR confirms that implemented changes met their objectives and did not create unintended consequences, closing the PDCA loop.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Continuous Improvement & Updates 2