CAPA CAPA Change Control & Management 1

Question 1

What is the primary purpose of change control within a CAPA system?

Accepted Answer

To ensure changes are documented, reviewed, and approved before implementation

Answer

Change control ensures that any modification to a process, product, or system is formally evaluated and authorized before it is enacted.

Question 2

Which document typically initiates the formal change control process within a CAPA?

Accepted Answer

Change Request (CR)

Answer

A Change Request formally describes the proposed change, its rationale, and its potential impact, triggering the review and approval workflow.

Question 3

In the context of CAPA, what does 'impact assessment' during change control evaluate?

Accepted Answer

The potential effect of the change on product quality, safety, and regulatory compliance

Answer

Impact assessment identifies all systems, processes, and documents that may be affected so that risks to quality and compliance are understood before approval.

Question 4

When must a CAPA-driven change be verified before full implementation in a regulated US environment?

Accepted Answer

After a risk-based review confirms the change does not introduce new hazards

Answer

21 CFR Part 820 and FDA expectations require that changes be verified or validated as appropriate before implementation to ensure they achieve the desired outcome without introducing new risk.

Question 5

Which of the following best describes 'uncontrolled change' in a CAPA context?

Accepted Answer

A modification implemented without formal approval, documentation, or assessment

Answer

Uncontrolled change bypasses the formal change control process, creating regulatory risk and potential product quality issues.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA CAPA Change Control & Management 1