Comprehensive Guide to CAPA in Pharmaceutical Quality Management – Study Guide, Exam Review & Practice Questions 2026/2027

Comprehensive Guide to CAPA in Pharmaceutical Quality Management
Comprehensive Guide to CAPA in Pharmaceutical Quality Management
Study online at https://quizlet.com/_jsmqfb

1. What does CAPA stand for? Corrective and Preventive Ac-
tion




2. What is the ultimate purpose of CAPA? To assure that a problem can
never be experienced again.

3. What is the first step in the CAPA process? Identification of the problem.

4. What should be included in the identification step? Source of information, de-
tailed explanation of the
problem, and documentation
of evidence.

5. What is evaluated in the evaluation step of CAPA? The need for action and the
level of action required based
on potential impact and risks.

6. What must be assessed during the evaluation step? Potential impact of the prob-
lem and assessment of risk.

7. What does the investigation step require? A written procedure to ensure
a complete investigation.

8. What is the goal of the analysis step in CAPA? To determine the root cause of
the problem.

9. What must be documented during the analysis step? All possible causes and the re-
sults of data collection.

10. What is an action plan in the CAPA process?

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