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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Reviewing test methods against compendial requirements is important to ensure:
Response:

A) The quickest method is chosen for all tests.
B) Methods are chosen based on their complexity.
C) Only non-compendial methods are used in the lab.
D) Compliance with both general and informational compendial chapters as needed.

2. ICH Q10 integrates elements of _____ and continual improvement into the quality management system.
Response:

A) investor relations
B) profit maximization
C) product lifecycle
D) competitive analysis

3. Audit evidence should be _____ to confirm audit completion and findings.
Response:

A) estimated
B) documented
C) ignored
D) deleted

4. What are the goals of a metrology program in pharmaceutical manufacturing?
(Choose two)
Response:

A) Achieving celebrity endorsements for the manufacturing process
B) Maintaining compliance with regulatory requirements
C) Showcasing the facility's technological advancements on social media
D) Ensuring measurement accuracy and reliability

5. Which compendium is a requirement for marketing authorization in the United States?
Response:

A) Japanese Pharmacopoeia (JP)
B) European Pharmacopoeia (EP)
C) United States Pharmacopoeia (USP)
D) All of the above

Solutions: