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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. The GMP document system includes various types of documents. Which of the following is NOT typically included?
Response:

A) Master plans.
B) Manufacturing instructions.
C) Test instructions.
D) Personal employee emails.

2. Biological product deviation reports are crucial for:
Response:

A) Logging daily employee attendance
B) Reporting changes in executive leadership
C) Cataloging cafeteria incidents
D) Tracking deviations in biological product manufacturing or handling

3. Remote audits are particularly useful when:Response:

A) The organization is too large for in-person audits
B) The weather conditions are unfavorable
C) In-person travel is restricted
D) Auditors prefer not to travel

4. Which of these events typically triggers a CAPA in a quality management system?
Response:

A) An annual review meeting
B) An observed deviation from standard operating procedures
C) A scheduled audit with no findings
D) A successful product launch

5. What are essential elements to review in Certificates of Analysis (COAs)?
(Choose two)
Response:

A) Appropriate retention and accessibility
B) Color of the product
C) Completeness and internal review
D) Marketing claims

Solutions: